Quality Engineer Jobs at Thermo Fisher Scientific with Visa Sponsorship
Quality Engineer jobs at Thermo Fisher Scientific sit at the intersection of regulatory compliance and scientific manufacturing, covering everything from incoming inspection to CAPA management across life sciences and diagnostics. Thermo Fisher has a consistent track record of sponsoring international candidates for quality-focused engineering positions.
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Get Access To All JobsWork Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
How Will You Make an Impact
The Manager, QA Document Control & Training Compliance provides site leadership and governance for GMP document control, records management, learning management, and training compliance across a large sterile injectable pharmaceutical manufacturing operation. The role ensures controlled documents and training systems remain compliant, inspection-ready, accurate, traceable, and effective throughout their lifecycle.
This leader serves as the site system owner and subject-matter expert for document and learning management processes, builds a high-performing compliance team, partners with Manufacturing, Quality Control, Engineering, Technical Operations and other functions, and drives sustainable improvements that support aseptic manufacturing, data integrity, operational readiness, and timely delivery to customers and patients.
A Day in the Life
Leadership & Quality Systems Governance
- Lead, coach, and develop the Document Control and Training Compliance team; establish objectives aligned with site Quality and business priorities and foster a culture of quality, accountability, teamwork, and continuous improvement.
- Act as site process/system owner for the electronic document management system (eDMS) and learning management system (LMS), including governance, access, workflows, business processes, data integrity, and sustained compliance.
- Own procedures, standards, metrics, and governance for controlled documents, GMP records, training administration, curricula, and qualification records.
- Partner cross-functionally to identify compliance risks, resolve systemic issues, implement CAPAs and change controls, and improve Quality Management System effectiveness.
Document Control & Records Management
- Oversee the complete lifecycle of controlled GMP documents, including SOPs, work instructions, forms, specifications, protocols, master batch records and other site-controlled content: authoring, review, approval, issuance, effective-date management, revision, periodic review, obsolescence, archival and retrieval.
- Ensure document workflows meet cGMP, Good Documentation Practices (GDP), corporate Quality standards, site procedures, and applicable regulatory requirements.
- Maintain robust version control, access control, traceability, reconciliation, and archival practices for paper and electronic GMP records.
- Own or oversee periodic review programs and ensure documents are reviewed, revised, retired, and made effective within established timelines.
- Manage GMP record retention, archive, retrieval, and destruction processes in accordance with approved retention requirements.
- Drive continuous improvement and standardization of document-control workflows to reduce cycle time, backlog, errors, and compliance risk.
Training Compliance & Learning Management
- Lead the site training compliance program and maintain the LMS in a validated and compliant state in accordance with regulations, corporate requirements, and site procedures.
- Oversee training lifecycle activities including course creation, assignment, effective-date coordination, training verification, curricula creation and maintenance, qualification status, inactivation, and removal of obsolete training.
- Ensure training requirements are role-based, current, and aligned with approved procedures and job responsibilities; monitor completion and escalation of overdue or at-risk training.
- Provide governance for GMP onboarding and new-hire training and ensure appropriate integration with functional and aseptic/sterile manufacturing qualification programs.
- Partner with functional SMEs to improve training effectiveness, instructional design, curricula architecture, and training-change impact assessments.
- Analyze training compliance data and trends to identify gaps, recurring issues, and opportunities to improve learning effectiveness and inspection readiness.
Inspection Readiness, Metrics & Continuous Improvement
- Serve as the primary Quality Systems point of contact for document-control and training inquiries during regulatory inspections, corporate audits, and client audits; retrieve evidence promptly and ensure responses are accurate and complete.
- Develop and report KPIs for document lifecycle performance, periodic reviews, training completion, overdue training, curricula health, records management, and related compliance indicators for Quality Review and site governance forums.
- Ensure audit and inspection observations related to documentation or training are investigated, remediated, and sustained through effective corrective and preventive actions.
- Maintain continuous inspection readiness and promote behaviors consistent with cGMP, GDP, data integrity, and a strong site Quality culture.
Education
Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Quality Assurance, or related field required. (Master’s preferred).
Experience
- Minimum 6 years of experience in pharmaceutical or biopharmaceutical manufacturing, Quality Systems, compliance, document control, or GMP training, with at least 3 years in a leadership or people-management role.
- Experience supporting a large, complex GMP manufacturing site; sterile injectable, aseptic processing, biologics, or other highly regulated manufacturing experience strongly preferred.
- Demonstrated experience managing GMP document lifecycle processes and electronic document management systems (eDMS).
- Demonstrated experience with LMS administration, training compliance, curricula management, or GMP learning systems.
- Experience supporting regulatory inspections and customer/client audits and providing rapid, accurate documentation and training evidence.
- Working knowledge of applicable cGMP requirements, including FDA 21 CFR Parts 210/211, Good Documentation Practices, data integrity principles, and pharmaceutical Quality Systems; familiarity with ICH Q10 preferred.
- Experience with systems such as Veeva, MasterControl, TrackWise, SuccessFactors, ComplianceWire, or similar Quality/document/training platforms is preferred.
- Quality, Lean, Six Sigma, training, or instructional-design certification is an asset.
Knowledge, Skills, Abilities
- Strong knowledge of cGMP, GDP, controlled-document practices, records management, training compliance, and Quality Systems governance.
- Ability to translate regulatory and corporate requirements into practical, sustainable site processes and controls.
- Excellent leadership, coaching, change-management, and team-development capabilities.
- Advanced organizational, record-keeping, analytical, and problem-solving skills with exceptional attention to detail and accuracy.
- Ability to manage competing priorities, high transaction volumes, and time-sensitive commitments in a fast-paced regulated manufacturing environment.
- Strong written, verbal, presentation, and interpersonal communication skills; able to interact effectively with operators, technical SMEs, site leadership, customers, auditors, and regulatory inspectors.
- Proficiency with electronic Quality systems, databases, reporting tools, and Microsoft Office applications.
- Ability to lead cross-functional projects and influence without direct authority while maintaining a strong customer-service and compliance mindset.
Physical Requirements/Work Environment
Position requires ordinary ambulatory skills and physical coordination sufficient to move throughout office and manufacturing areas and to sit, stand, walk, reach, bend, stoop, kneel, and crouch periodically. May enter controlled manufacturing and cleanroom areas and must be able to comply with site gowning, hygiene, PPE, and safety requirements, including restrictions applicable to sterile manufacturing areas. Ability to use a computer, keyboard, and monitor and review electronic and paper records for prolonged periods. May occasionally lift and move light to medium materials in accordance with site requirements.
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
How Will You Make an Impact
The Manager, QA Document Control & Training Compliance provides site leadership and governance for GMP document control, records management, learning management, and training compliance across a large sterile injectable pharmaceutical manufacturing operation. The role ensures controlled documents and training systems remain compliant, inspection-ready, accurate, traceable, and effective throughout their lifecycle.
This leader serves as the site system owner and subject-matter expert for document and learning management processes, builds a high-performing compliance team, partners with Manufacturing, Quality Control, Engineering, Technical Operations and other functions, and drives sustainable improvements that support aseptic manufacturing, data integrity, operational readiness, and timely delivery to customers and patients.
A Day in the Life
Leadership & Quality Systems Governance
- Lead, coach, and develop the Document Control and Training Compliance team; establish objectives aligned with site Quality and business priorities and foster a culture of quality, accountability, teamwork, and continuous improvement.
- Act as site process/system owner for the electronic document management system (eDMS) and learning management system (LMS), including governance, access, workflows, business processes, data integrity, and sustained compliance.
- Own procedures, standards, metrics, and governance for controlled documents, GMP records, training administration, curricula, and qualification records.
- Partner cross-functionally to identify compliance risks, resolve systemic issues, implement CAPAs and change controls, and improve Quality Management System effectiveness.
Document Control & Records Management
- Oversee the complete lifecycle of controlled GMP documents, including SOPs, work instructions, forms, specifications, protocols, master batch records and other site-controlled content: authoring, review, approval, issuance, effective-date management, revision, periodic review, obsolescence, archival and retrieval.
- Ensure document workflows meet cGMP, Good Documentation Practices (GDP), corporate Quality standards, site procedures, and applicable regulatory requirements.
- Maintain robust version control, access control, traceability, reconciliation, and archival practices for paper and electronic GMP records.
- Own or oversee periodic review programs and ensure documents are reviewed, revised, retired, and made effective within established timelines.
- Manage GMP record retention, archive, retrieval, and destruction processes in accordance with approved retention requirements.
- Drive continuous improvement and standardization of document-control workflows to reduce cycle time, backlog, errors, and compliance risk.
Training Compliance & Learning Management
- Lead the site training compliance program and maintain the LMS in a validated and compliant state in accordance with regulations, corporate requirements, and site procedures.
- Oversee training lifecycle activities including course creation, assignment, effective-date coordination, training verification, curricula creation and maintenance, qualification status, inactivation, and removal of obsolete training.
- Ensure training requirements are role-based, current, and aligned with approved procedures and job responsibilities; monitor completion and escalation of overdue or at-risk training.
- Provide governance for GMP onboarding and new-hire training and ensure appropriate integration with functional and aseptic/sterile manufacturing qualification programs.
- Partner with functional SMEs to improve training effectiveness, instructional design, curricula architecture, and training-change impact assessments.
- Analyze training compliance data and trends to identify gaps, recurring issues, and opportunities to improve learning effectiveness and inspection readiness.
Inspection Readiness, Metrics & Continuous Improvement
- Serve as the primary Quality Systems point of contact for document-control and training inquiries during regulatory inspections, corporate audits, and client audits; retrieve evidence promptly and ensure responses are accurate and complete.
- Develop and report KPIs for document lifecycle performance, periodic reviews, training completion, overdue training, curricula health, records management, and related compliance indicators for Quality Review and site governance forums.
- Ensure audit and inspection observations related to documentation or training are investigated, remediated, and sustained through effective corrective and preventive actions.
- Maintain continuous inspection readiness and promote behaviors consistent with cGMP, GDP, data integrity, and a strong site Quality culture.
Education
Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Quality Assurance, or related field required. (Master’s preferred).
Experience
- Minimum 6 years of experience in pharmaceutical or biopharmaceutical manufacturing, Quality Systems, compliance, document control, or GMP training, with at least 3 years in a leadership or people-management role.
- Experience supporting a large, complex GMP manufacturing site; sterile injectable, aseptic processing, biologics, or other highly regulated manufacturing experience strongly preferred.
- Demonstrated experience managing GMP document lifecycle processes and electronic document management systems (eDMS).
- Demonstrated experience with LMS administration, training compliance, curricula management, or GMP learning systems.
- Experience supporting regulatory inspections and customer/client audits and providing rapid, accurate documentation and training evidence.
- Working knowledge of applicable cGMP requirements, including FDA 21 CFR Parts 210/211, Good Documentation Practices, data integrity principles, and pharmaceutical Quality Systems; familiarity with ICH Q10 preferred.
- Experience with systems such as Veeva, MasterControl, TrackWise, SuccessFactors, ComplianceWire, or similar Quality/document/training platforms is preferred.
- Quality, Lean, Six Sigma, training, or instructional-design certification is an asset.
Knowledge, Skills, Abilities
- Strong knowledge of cGMP, GDP, controlled-document practices, records management, training compliance, and Quality Systems governance.
- Ability to translate regulatory and corporate requirements into practical, sustainable site processes and controls.
- Excellent leadership, coaching, change-management, and team-development capabilities.
- Advanced organizational, record-keeping, analytical, and problem-solving skills with exceptional attention to detail and accuracy.
- Ability to manage competing priorities, high transaction volumes, and time-sensitive commitments in a fast-paced regulated manufacturing environment.
- Strong written, verbal, presentation, and interpersonal communication skills; able to interact effectively with operators, technical SMEs, site leadership, customers, auditors, and regulatory inspectors.
- Proficiency with electronic Quality systems, databases, reporting tools, and Microsoft Office applications.
- Ability to lead cross-functional projects and influence without direct authority while maintaining a strong customer-service and compliance mindset.
Physical Requirements/Work Environment
Position requires ordinary ambulatory skills and physical coordination sufficient to move throughout office and manufacturing areas and to sit, stand, walk, reach, bend, stoop, kneel, and crouch periodically. May enter controlled manufacturing and cleanroom areas and must be able to comply with site gowning, hygiene, PPE, and safety requirements, including restrictions applicable to sterile manufacturing areas. Ability to use a computer, keyboard, and monitor and review electronic and paper records for prolonged periods. May occasionally lift and move light to medium materials in accordance with site requirements.
See all Quality Engineer Jobs at Thermo Fisher Scientific
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Quality Engineer Jobs at Thermo Fisher Scientific.
Get Access To All JobsTips for Finding Quality Engineer Jobs at Thermo Fisher Scientific
Align your credentials to FDA-regulated environments
Thermo Fisher's Quality Engineer roles in life sciences and diagnostics require familiarity with FDA 21 CFR Part 820 and ISO 13485. Documenting hands-on experience with these standards on your resume directly matches what hiring managers screen for.
Target sites with active manufacturing operations
Thermo Fisher's sponsorship activity for Quality Engineers clusters around its manufacturing and production facilities, not corporate offices. Search by location for sites in states like Massachusetts, Pennsylvania, and California where regulated manufacturing runs continuously.
Browse open Quality Engineer roles on Migrate Mate
Use Migrate Mate to filter Quality Engineer openings at Thermo Fisher Scientific by visa type, so you only see roles where sponsorship is confirmed. This removes the guesswork before you invest time in a full application.
Clarify your OPT or CPT timeline during screening
If you're on F-1 OPT, tell the recruiter your authorization end date and STEM extension eligibility upfront. Quality Engineer roles often take 60 to 90 days to fill, and Thermo Fisher needs that lead time to align filing deadlines with your start date.
Understand how TN status works for this role
Canadian and Mexican nationals can qualify for TN status under the engineer category if the Quality Engineer role requires a relevant bachelor's degree. Confirm with your hiring contact that the job description lists a specific engineering or science degree requirement, since TN adjudicators scrutinize this closely.
Confirm PERM sponsorship intent before accepting an offer
For Green Card sponsorship through EB-2 or EB-3, Thermo Fisher typically initiates PERM labor certification after you've established a performance record. Ask explicitly during offer negotiation whether the role is eligible for immigrant visa sponsorship and what the expected timeline looks like.
Frequently Asked Questions
Does Thermo Fisher Scientific sponsor H-1B visas for Quality Engineers?
Yes, Thermo Fisher Scientific sponsors H-1B visas for Quality Engineer positions. The company participates in the H-1B cap lottery each April and also files cap-exempt petitions for qualifying facilities. Because Quality Engineer roles require a specific technical degree, they generally satisfy USCIS specialty occupation requirements, which strengthens the petition.
Which visa types are commonly used for Quality Engineer roles at Thermo Fisher Scientific?
H-1B is the most common route for Quality Engineers at Thermo Fisher. F-1 OPT and CPT are used for recent graduates entering quality roles, with STEM OPT extensions available for qualifying degree holders. TN visa status is an option for Canadian and Mexican nationals in engineering classifications, and Green Card sponsorship via EB-2 or EB-3 is available for longer-term employees.
What qualifications does Thermo Fisher Scientific expect for Quality Engineer roles?
Most Quality Engineer postings at Thermo Fisher require a bachelor's degree in engineering, life sciences, or a closely related field. Practical experience with quality management systems, nonconformance handling, and root cause analysis is standard. Familiarity with ISO 13485, FDA 21 CFR Part 820, or GMP environments is a strong differentiator, particularly for roles in medical devices or bioproduction.
How do I apply for Quality Engineer jobs at Thermo Fisher Scientific?
You can search and apply through Thermo Fisher's careers portal directly. To focus specifically on roles that include visa sponsorship, use Migrate Mate to browse verified Quality Engineer openings at Thermo Fisher filtered by visa type. Applications typically require a resume, and some postings ask for a brief cover letter outlining relevant quality systems experience.
How do I manage the timing between my visa status and a Quality Engineer offer at Thermo Fisher Scientific?
Timing is the most common friction point for international candidates. If you're on OPT, confirm how many months of authorization remain and whether your degree qualifies for a STEM extension, which provides up to 24 additional months. For H-1B, petitions filed under the cap have an October 1 start date, so offers extended in spring need a gap plan or an OPT bridge. Raise this with your recruiter early.