New · posted Oct 19
Embecta · Medical Devices
Senior Quality Engineer
- Remote, US
- Remote
- Full-time
- Senior & Principal
Open until filled
The role
Ensure product complaint investigations, procedures, and other activities comply with FDA Quality System Regulations, ISO, and Medical Device Directives for Vigilance. Maintain good laboratory practices (GLP) consistent with product development objectives and regulatory requirements. Review Customer complaint investigations for validity and assures they are processed and investigated in compliance with Corporate and Unit policies and procedures. Revise SOPs and enforce compliance with equipment maintenance protocols, hazmat management, as well as biohazard and disposal management on behalf of the laboratory team. Perform FTIR analysis to identify various materials, including completing foreign matter complaint investigations. Program mechanical lab equipment such as Chatillon. Perform qualitative and quantitative analysis and critically analyze data generated. Provide audit support (preparation, lab tour and related activities). 100% telecommuting role. Reports to company headquarters in Parsippany, NJ. Can work remotely or telecommute.
embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. Driven by innovation, purpose, and a commitment to improving lives, we are expanding our portfolio of solutions to serve even more patients, healthcare providers, and communities around the world.
What you need
Master’s degree in Engineering (any) or related field of study and three (3) years of work experience in the job offered or related occupation in which the required experience was gained. In lieu of a Master’s degree in Engineering (any) or related field of study and three (3) years of work experience in the job offered or related occupation in which the required experience was gained, employer will also accept a Bachelor’s degree in Engineering (any) or related field of study and five (5) years of work experience in the job offered or related occupation in which the required experience was gained. Must also have demonstrated experience in the following: Regulatory and international standards requirements including 21 CFR 820, ISO 13485, and ISO 14971 to support quality engineering activities; Statistics for trend analysis and complaint data evaluation; Product failure modes; Quality Engineering tools such as: Root Cause Analysis, Design of Experiments and Statistical Analysis; Quality Audit Management (Internal and External) - performing internal audits and representing the QMS during external notified body audits; Corrective and Preventive Action (CAPA) to investigate root causes; and Engineering Design Change Management and DHF Management for Medical Devices.
Primary Work Location:
300 Kimball Dr, Parsippany, NJ 07054
Additional Locations:
N/A
Work Shift:
Not Specified
To apply, submit a resume to https://nj.gov/labor/career-services/, OR submit a resume to https://www.embecta.com/en-us/careers, OR mail resume to Embecta Corp., Attn: HR, 300 Kimball Dr, Parsipanny, NJ 07054. Must reference Job Title & Job Code: R21-00608359 EOE.
Pay
$139,922 – $168,800 a year
Employer providedSalary offered for the position is: $139,922.00 - $168,800.00/year.
Equal opportunity, accessibility and legal noticesEmbecta's statements, word for word
embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Job intelligence
The context around this role
Live data · October 20, 2026
Salary intelligence
How the pay compares
This role's midpoint is 28% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in New Jersey15 roles publishing pay
Senior & Principal roles in the US302 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $139,922 | — | $168,800 |
| New Jersey (middle half) | $105,750 | $130,000 | $148,750 |
| All US (middle half) | $102,625 | $120,250 | $137,500 |
This role: Embecta's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 20, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 895 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Embecta's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 10 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance2
- Investigations and CAPA2
- Quality systems and risk2
- Lab testing and methods1
- Documentation and SOPs1
- Data and digital systems1
- Collaboration and leadership1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
Company hiring pulse
Embecta on Regulatory Jobs
- 2
- Open roles
- 2
- Distinct roles
- 2
- Locations
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Senior Quality Engineer at Embecta
Open until filled. $140K–$169K a year, employer provided.