H-1B1 Singapore Visa Quality Engineer Jobs
Quality Engineer jobs in the U.S. are open to Singaporean nationals through H-1B1 visa sponsorship, a consulate-processed path with no lottery and a 5,400-annual cap that goes largely unused. Employers in manufacturing, semiconductors, and medical devices regularly file for this role, and your specialty occupation status is well-established under the U.S.-Singapore Free Trade Agreement.
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About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
The Senior Quality Engineer, Risk Management has various objective/functions related to Third Party Manufacturing (TPM) plants and PQA functions. During routine operations, the Senior PQA Analyst is responsible for supporting the day to day Quality Assurance activities related to the TPM plants including but not limited to approval of manufacturing direction to the production floor, review and approval of manufacturing, laboratory, and raw material investigations, assess product impact analysis and corrective and preventive action for events, review and approval of changes as applicable. The Senior PQA Analyst also is responsible to evaluate supplier change notification, monitor process track and trending, and perform annual Product Quality Reviews. This person also acts as a liaison between AbbVie regulatory areas and TPM plants for regulatory submission.
Responsibilities
- Maintains an effective liaison and cooperative relationship with other AbbVie Areas including but not limited Quality, Regulatory, Technical, Supply Chain, along with the TPM sites.
- Ensures that bulk drug substance and/or drug product production at TPM sites is performed as per current good manufacturing practices, according to local procedures and as per specifications and manufacturing directions provided by AbbVie QA Operations.
- Ensures TPM procedures including but not limited to raw material specification, product specification, test methods, supplier change notification, shipping, are in compliance with cGMP, policies, regulatory approvals, and Quality Technical Agreement with TPM site.
- Review and approve manufacturing directions to the production floor.
- Provide support to PQA in global projects and events to ensure intended results are achieved; including planning, risk analysis, and implementation.
- Ensures investigations of TPM plant events related but not limited to process, laboratory, raw materials are completed thoroughly and documented accurately, including adequate product impact analyses and corrective and preventive action for plant events are documented.
- Perform annual Product Quality Review according to AbbVie global procedure to comply with regulatory requirements.
- Participates in Trend Review Board to monitor process track and trending.
- Participates in the Global Change Review Board (GCRB) meeting as TPM representative to evaluate global changes related but not limited to supplier change notifications, process, laboratory, and regulatory submissions that impacts all sites.
- Generates detailed change management plans related to TPM plants changes to ensure intended results are achieved; including planning, risk analysis, and implementation.
Qualifications
- Bachelor’s degree preferably in Engineering or Science
- Six years of experience within the Pharmaceutical operations, preferably Biologic manufacturing process
- Knowledge of GMP regulations and standards affecting pharmaceutical products
- Comprehensive knowledge and application of business and quality concepts
- Strong analytical skills and attention to detail
- Change plan, Exception Reports, SAP and LRMS experience is highly preferred
- Proven ability to adapt communication style for a variety of modes as well as for multicultural audiences
- Strong interpersonal relations / communications skills. Ability to effectively communicate across all levels of the organization
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
The Senior Quality Engineer, Risk Management has various objective/functions related to Third Party Manufacturing (TPM) plants and PQA functions. During routine operations, the Senior PQA Analyst is responsible for supporting the day to day Quality Assurance activities related to the TPM plants including but not limited to approval of manufacturing direction to the production floor, review and approval of manufacturing, laboratory, and raw material investigations, assess product impact analysis and corrective and preventive action for events, review and approval of changes as applicable. The Senior PQA Analyst also is responsible to evaluate supplier change notification, monitor process track and trending, and perform annual Product Quality Reviews. This person also acts as a liaison between AbbVie regulatory areas and TPM plants for regulatory submission.
Responsibilities
- Maintains an effective liaison and cooperative relationship with other AbbVie Areas including but not limited Quality, Regulatory, Technical, Supply Chain, along with the TPM sites.
- Ensures that bulk drug substance and/or drug product production at TPM sites is performed as per current good manufacturing practices, according to local procedures and as per specifications and manufacturing directions provided by AbbVie QA Operations.
- Ensures TPM procedures including but not limited to raw material specification, product specification, test methods, supplier change notification, shipping, are in compliance with cGMP, policies, regulatory approvals, and Quality Technical Agreement with TPM site.
- Review and approve manufacturing directions to the production floor.
- Provide support to PQA in global projects and events to ensure intended results are achieved; including planning, risk analysis, and implementation.
- Ensures investigations of TPM plant events related but not limited to process, laboratory, raw materials are completed thoroughly and documented accurately, including adequate product impact analyses and corrective and preventive action for plant events are documented.
- Perform annual Product Quality Review according to AbbVie global procedure to comply with regulatory requirements.
- Participates in Trend Review Board to monitor process track and trending.
- Participates in the Global Change Review Board (GCRB) meeting as TPM representative to evaluate global changes related but not limited to supplier change notifications, process, laboratory, and regulatory submissions that impacts all sites.
- Generates detailed change management plans related to TPM plants changes to ensure intended results are achieved; including planning, risk analysis, and implementation.
Qualifications
- Bachelor’s degree preferably in Engineering or Science
- Six years of experience within the Pharmaceutical operations, preferably Biologic manufacturing process
- Knowledge of GMP regulations and standards affecting pharmaceutical products
- Comprehensive knowledge and application of business and quality concepts
- Strong analytical skills and attention to detail
- Change plan, Exception Reports, SAP and LRMS experience is highly preferred
- Proven ability to adapt communication style for a variety of modes as well as for multicultural audiences
- Strong interpersonal relations / communications skills. Ability to effectively communicate across all levels of the organization
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
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Get Access To All JobsTips for Finding Visa Sponsorship as a Quality Engineer
Align your credentials to U.S. specialty occupation standards
Pull the O*NET profile for Quality Engineer and confirm your NUS, NTU, or polytechnic degree maps to its required field of study. Consular officers assess specialty occupation at the interview, so document the degree-to-role connection before you apply.
Target industries with consistent H-1B1 filing histories
Semiconductor fabrication, aerospace, and medical device manufacturers file H-1B1 visa petitions for Quality Engineers far more consistently than generalist employers. Narrow your search to these sectors to avoid landing at a company that has never navigated consulate-processed sponsorship.
Search verified sponsoring employers on Migrate Mate
Use Migrate Mate to filter employers by H-1B1 filing history for Quality Engineer roles. This surfaces companies that have already handled the DOL Labor Condition Application process, which shortens your path from offer to visa stamp considerably.
Confirm the employer will certify the LCA before you resign
The DOL must certify the Labor Condition Application before your consular interview can proceed. Ask the hiring manager whether their legal team has handled LCA filings before, and get a written timeline for that step as a condition of accepting the offer.
Check prevailing wage requirements using OFLC Wage Search
Your offered salary must meet the DOL prevailing wage for Quality Engineer in the specific metro area where you'll work. Run the OFLC Wage Search before salary negotiations so you know the floor and can flag underpayment risks early in the process.
Prepare your nonimmigrant intent documentation for the consular interview
Unlike H-1B visa, H-1B1 does not confer dual intent, so the consular officer will probe your ties to Singapore. Bring CPF statements, property records, or proof of family residence to demonstrate you intend to return after your authorized stay.
Frequently Asked Questions
Does a Quality Engineer role qualify as a specialty occupation for H-1B1 Singapore?
Yes. Quality Engineer is classified under engineering and applied sciences occupations, which USCIS recognizes as specialty occupations requiring at least a bachelor's degree in a directly related field. Your degree in mechanical, industrial, or manufacturing engineering from a Singaporean university supports this classification, provided your employer documents the degree-to-role connection in the Labor Condition Application.
How does the H-1B1 Singapore differ from H-1B for Quality Engineer roles?
H-1B1 has no lottery, no USCIS petition approval process, and a dedicated annual cap of 5,400 visas for Singaporeans that rarely fills. For Quality Engineers, this means you can pursue sponsorship year-round without the April registration window that H-1B requires. The trade-off is that H-1B1 does not allow dual intent, so demonstrating nonimmigrant intent at the consular interview is a real requirement H-1B holders don't face.
How do I find employers that have sponsored Quality Engineers on H-1B1 Singapore before?
Migrate Mate lets you filter job listings by visa type and employer filing history, so you can identify companies that have already handled H-1B1 Labor Condition Applications for engineering roles. Starting your search this way filters out employers unfamiliar with the consulate-processed pathway, which is the most common source of delays for Singaporean applicants in technical roles.
Can I switch employers while on H-1B1 as a Quality Engineer in the U.S.?
Yes, but each employer change requires a new Labor Condition Application certified by DOL and a new H-1B1 stamp obtained at a consulate outside the U.S. There is no portability provision equivalent to what H-1B holders have under AC21. If your new employer's LCA process takes longer than expected, you may need to time your consular visit carefully to avoid a gap in work authorization.
What documents does a Quality Engineer need for the H-1B1 consular interview?
You'll need your certified Labor Condition Application, offer letter specifying your role and salary, academic transcripts and degree certificates confirming your engineering qualification, DS-160 confirmation, and evidence of nonimmigrant intent such as CPF records or proof of ties to Singapore. Quality-specific certifications like ASQ credentials can strengthen your specialty occupation case but are not required by USCIS or the consulate.
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