Quality Assurance Engineer Visa Sponsorship Jobs in Delaware
Quality assurance engineer visa sponsorship jobs in Delaware are concentrated around Wilmington, where financial services firms, pharmaceutical companies, and technology contractors drive consistent demand. Major employers including JPMorgan Chase, DuPont, and AstraZeneca have established engineering operations in the state, making Delaware a practical target for international QA professionals seeking sponsorship.
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Get Access To All JobsINTRODUCTION
Designs, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products. Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution. Designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products. Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary. May assure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma).
Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Some barriers to entry exist at this level (e.g., dept/peer review). Level at which career may plateau. Determines methods and procedures on new assignments and may coordinate activities of other personnel (Team Lead).
Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Networks with key contacts outside own area of expertise.
Essential Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
- Model all quality values and coaches others on BSH quality system requirements and standards to elevate team's ability to produce high-quality products and implement best practices that emphasize defect prevention, reduction in variation and waste and provide for continuous improvement. Collaborate and communicate effectively with junior level employees, peers and cross-functional teams across all levels of the organization.
- Participate as a core team to plan tasks, address resource needs and provides technical quality engineering expertise to the development of products and manufacturing processes to ensure robust product builds and the production of high-quality products and manufacturing practices.
- Accountable for ensuring that the products produced meet applicable regulatory and quality standards and customer expectations.
- Owns the development, training delivery and monitoring of procedures, investigation procedures and test methods to assure compliance with QMS, Medical Device Quality System Regulation and Medical Device Directive Requirements.
- Acts with urgency to identify and lead the timely resolution of quality issues.
- Accountable for risk management, defect investigation, customer complaint and corrective action activities. Leads quality projects and will provide cost, schedule and resource needs for assigned projects. Responsible for monitoring and providing regular communication and updates on success factors such as progress, schedule, budget, project risks and resource of needs gaps.
- Reviews technical publications, articles and abstracts to stay abreast of technical developments in the industry. Collaborates with other engineers and promotes learning, development and knowledge transfer. Mentors and coaches less senior staff.
- Provides technical expertise for Non-Conformance Events risk assessments and planned deviations.
- Accountable for the creation of technical protocols, technical reports, and complaint investigation reports.
- Accountable for processes such as MRB, NCE, CAPA and SCAR process.
- Accountable for review and approval process for ECO’s product related change orders, engineering studies, sustaining engineering products, specifications, drawings, manufacturing procedures, design process verification and validation documentation.
- Develops Product Quality Plans.
- Lead plant efforts to maintain quality requirements and certifications. Accountable compliance required facility and supplier audits and Notified Body and FDA inspections.
- May participate in external collaborations.
- May present results and progress for management and key external customer review.
- Identify and recommend improvements to the organization, processes, procedures and the Quality Management System.
- Drives the development of efficient, consistent processes and builds a workplace culture of continuous improvement. Champions opportunities to implement new tools, technologies and methods.
QUALIFICATIONS
Education
- Bachelor’s Degree (Technical Field Preferred), May have Master’s Degree, May have PhD
Experience
- 8+ Years with Bachelor’s Degree
- 6+ Years with Master’s Degree
- 3+ Years with PhD
Skills Required
- Advanced knowledge of ERP and PLM Systems, word processing, spreadsheet programs and databases
- Ability to lead and motivate a high performing project team and supervise execution of projects, keep to timelines and prioritize resources
- Excellent ability to read, analyze and interpret professional journals, technical procedures and government regulations.
- Excellent collaboration and interpersonal skills. Adapts communication style to suite different audiences. Creates precise, accurate technical documentation. Able to facilitate group discussions.
- Very good working knowledge of medical device Quality System Regulations (21CFR820), ISO 13485 and MDD requirements.
- Ability to develop and deliver high quality presentations
- Comprehensive knowledge of manufacturing, investigation and quality improvement methodologies such as GMP, GDP CIMS, Lean, Root Cause and Root Cause Failure Analysis, TQM, SPC and Six Sigma
- Advanced ability to analyze data and come to valid scientific conclusions
- Ability to simultaneously manage multiple large-scale projects in various lifecycle stages
Beneficial
- Working knowledge of FDA and ISO regulations that govern the Medical Device
- Certified Quality Engineer
- Experience with sterilization and cleanroom processes.
Why join Hologic?
We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
The annualized base salary range for this role is $119,300 - $186,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.
Agency and Third-Party Recruiter Notice
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
INTRODUCTION
Designs, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products. Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution. Designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products. Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary. May assure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma).
Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Some barriers to entry exist at this level (e.g., dept/peer review). Level at which career may plateau. Determines methods and procedures on new assignments and may coordinate activities of other personnel (Team Lead).
Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Networks with key contacts outside own area of expertise.
Essential Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
- Model all quality values and coaches others on BSH quality system requirements and standards to elevate team's ability to produce high-quality products and implement best practices that emphasize defect prevention, reduction in variation and waste and provide for continuous improvement. Collaborate and communicate effectively with junior level employees, peers and cross-functional teams across all levels of the organization.
- Participate as a core team to plan tasks, address resource needs and provides technical quality engineering expertise to the development of products and manufacturing processes to ensure robust product builds and the production of high-quality products and manufacturing practices.
- Accountable for ensuring that the products produced meet applicable regulatory and quality standards and customer expectations.
- Owns the development, training delivery and monitoring of procedures, investigation procedures and test methods to assure compliance with QMS, Medical Device Quality System Regulation and Medical Device Directive Requirements.
- Acts with urgency to identify and lead the timely resolution of quality issues.
- Accountable for risk management, defect investigation, customer complaint and corrective action activities. Leads quality projects and will provide cost, schedule and resource needs for assigned projects. Responsible for monitoring and providing regular communication and updates on success factors such as progress, schedule, budget, project risks and resource of needs gaps.
- Reviews technical publications, articles and abstracts to stay abreast of technical developments in the industry. Collaborates with other engineers and promotes learning, development and knowledge transfer. Mentors and coaches less senior staff.
- Provides technical expertise for Non-Conformance Events risk assessments and planned deviations.
- Accountable for the creation of technical protocols, technical reports, and complaint investigation reports.
- Accountable for processes such as MRB, NCE, CAPA and SCAR process.
- Accountable for review and approval process for ECO’s product related change orders, engineering studies, sustaining engineering products, specifications, drawings, manufacturing procedures, design process verification and validation documentation.
- Develops Product Quality Plans.
- Lead plant efforts to maintain quality requirements and certifications. Accountable compliance required facility and supplier audits and Notified Body and FDA inspections.
- May participate in external collaborations.
- May present results and progress for management and key external customer review.
- Identify and recommend improvements to the organization, processes, procedures and the Quality Management System.
- Drives the development of efficient, consistent processes and builds a workplace culture of continuous improvement. Champions opportunities to implement new tools, technologies and methods.
QUALIFICATIONS
Education
- Bachelor’s Degree (Technical Field Preferred), May have Master’s Degree, May have PhD
Experience
- 8+ Years with Bachelor’s Degree
- 6+ Years with Master’s Degree
- 3+ Years with PhD
Skills Required
- Advanced knowledge of ERP and PLM Systems, word processing, spreadsheet programs and databases
- Ability to lead and motivate a high performing project team and supervise execution of projects, keep to timelines and prioritize resources
- Excellent ability to read, analyze and interpret professional journals, technical procedures and government regulations.
- Excellent collaboration and interpersonal skills. Adapts communication style to suite different audiences. Creates precise, accurate technical documentation. Able to facilitate group discussions.
- Very good working knowledge of medical device Quality System Regulations (21CFR820), ISO 13485 and MDD requirements.
- Ability to develop and deliver high quality presentations
- Comprehensive knowledge of manufacturing, investigation and quality improvement methodologies such as GMP, GDP CIMS, Lean, Root Cause and Root Cause Failure Analysis, TQM, SPC and Six Sigma
- Advanced ability to analyze data and come to valid scientific conclusions
- Ability to simultaneously manage multiple large-scale projects in various lifecycle stages
Beneficial
- Working knowledge of FDA and ISO regulations that govern the Medical Device
- Certified Quality Engineer
- Experience with sterilization and cleanroom processes.
Why join Hologic?
We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
The annualized base salary range for this role is $119,300 - $186,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.
Agency and Third-Party Recruiter Notice
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
Quality Assurance Engineer Job Roles in Delaware
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Search Quality Assurance Engineer Jobs in DelawareQuality Assurance Engineer Jobs in Delaware: Frequently Asked Questions
Which companies sponsor visas for quality assurance engineers in Delaware?
Delaware's largest visa sponsors for quality assurance engineers include financial services firms like JPMorgan Chase and Bank of America, life sciences companies like AstraZeneca and Incyte, and chemical and materials firms with roots in the state like DuPont. Defense and government contractors operating near Dover also file sponsorship petitions for QA roles with software testing and systems validation responsibilities.
Which visa types are most common for quality assurance engineer roles in Delaware?
The H-1B visa is the most common visa category for quality assurance engineers in Delaware, as QA roles involving software testing, automation frameworks, or systems validation typically qualify as specialty occupations requiring a related bachelor's degree. Some employers also sponsor L-1B visas for QA engineers transferring from a foreign affiliated office. Australian citizens may qualify for the E-3 visa as an alternative to the H-1B visa.
Which cities in Delaware have the most quality assurance engineer sponsorship jobs?
Wilmington accounts for the majority of quality assurance engineer sponsorship activity in Delaware, driven by its concentration of financial institutions, pharmaceutical headquarters, and technology firms. Newark, home to the University of Delaware and nearby corporate campuses, is a secondary hub. Dover sees some demand from government-adjacent contractors, though Wilmington remains the primary city for international QA candidates targeting Delaware employers.
How to find quality assurance engineer visa sponsorship jobs in Delaware?
Migrate Mate filters job listings specifically by visa sponsorship availability, making it straightforward to browse quality assurance engineer roles posted by Delaware employers who actively sponsor. Because QA titles vary widely across industries, searching variations like "QA engineer," "software quality engineer," and "test automation engineer" on Migrate Mate will surface the broadest set of sponsorship-eligible opportunities across Wilmington, Newark, and surrounding areas.
Are there state-specific considerations for quality assurance engineers seeking sponsorship in Delaware?
Delaware's incorporation-friendly legal environment draws a high density of financial and pharmaceutical corporations to Wilmington, which increases the pool of employers with established immigration programs and in-house legal teams experienced with H-1B sponsorship. The University of Delaware in Newark also creates a pipeline of graduates familiar to local employers, meaning QA candidates with ties to that institution may find it easier to engage hiring managers who regularly recruit from it.
What is the prevailing wage for sponsored quality assurance engineer jobs in Delaware?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.