Staff Quality Systems Engineer
Johnson & Johnson MedTech · Danvers, MA
- Level
- Senior
- Team
- Quality
- Base pay
- $96k–$155k
- Degree
- Preferred
- Experience asked
- 7+ years
- Certification
- Black Belt preferred
- Industry
- Medical devices
- Posted
- Yesterday
The role in 30 seconds
A senior quality role at Johnson & Johnson MedTech (medical devices) in Danvers, MA.
- They ask for
- 7+ years · degree preferred · Black Belt preferred
- Tools it names
- Lean, Six Sigma, Black Belt, Root cause, FMEA, CAPA
- Base pay
- $96k–$155k
- Day to day
- some off-shift / weekend coverage
Read from the posting. The full description is below.
From the plant jobs report · week of November 2, 2026
Quality Engineer roles in Massachusetts: typical posted base $107k–$155k. This one lists $96k–$155k.
Median of the low and high ends of 52 live postings that list pay, out of 84 quality engineer openings in Massachusetts, read from manufacturers' own careers sites.
Massachusetts plant jobs report →Pay by team and state →What moves pay →
How this role compares
Against 83 other live quality postings in Massachusetts.
- Base pay
- In line with similar roles
- Experience asked
- More than usual (7+ vs 5+)
Typical $102k–$138k, from 38 postings that list pay.
Similar roles usually ask 5+ years.
Skills these teams ask for most
- ✓ Root cause 67%
- ✓ FDA / GMP 51%
- ✓ CAPA 44%
- Validation (IQ/OQ/PQ) 44%
- ✓ ISO 13485 39%
- ✓ Supplier quality 35%
✓ = this posting asks for it too. % = share of similar postings that mention it.
Stands out: this posting asks for Black Belt, DOE, SAP, which few similar roles mention. If you have it, lead with it.
At a glance
Pulled from the posting text. If it's not listed here, the posting didn't say.
How to get in at this plant
Five moves over a week or two. The first one takes ten minutes.
- 1
Pick 2–3 people on the Quality team at Johnson & Johnson MedTech
We found 1 person at this company and state: 1 in this kind of role. Engineers who joined in the last year or two reply the most. See them ↓
- 2
Send a short, curious note
One real question about their work. No favors yet. Each person gets a different note, written for this role.
Write to Shuhui → (free) - 3
Turn a reply into a short call
Questions worth asking about this team:
- What does a normal week look like on your team?
- Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
- How much of the job is customer complaints versus prevention?
- How does off-shift and weekend coverage work?
- The posting mentions a Black Belt. Does the company sponsor certification?
- 4
Apply with someone vouching for you
If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.
- 5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.
This plant: Johnson & Johnson MedTech in Danvers
No other open roles at this site right now · 1 person we found in quality roles at Johnson & Johnson MedTech.
Full description from Johnson & Johnson MedTechAs posted on their careers site.ShowHide
Qualifications/Requirements
- ✓Bachelor’s degree in engineering, Life Sciences, or related field; advanced degree preferred.
- ✓Minimum 5–7 years of experience in quality engineering /quality systems within the medical device industry.
- ✓Deep understanding of FDA QSR (21 CFR Part 820), ISO 13485, and EU MDR.
- ✓Proven experience managing CAPAs and NCs in a regulated environment.
- ✓Strong analytical skills and proficiency in quality tools (e.g., 8D, FMEA, Six Sigma, Lean).
- ✓Experience with electronic QMS platforms (e.g., EtQ,SAP).
- ✓Excellent communication, leadership, and project management skills.
- ✓Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE), Lean Six Sigma Black Belt or similar preferred.
- ✓Experience with complaint handling, design controls, and post-market surveillance preferred.
- ✓Familiarity with global regulatory
requirements
(e.g., USFDA, Health Canada, TGA, PMDA) preferred.
- ✓Ability to influence cross-functional teams and drive quality culture preferred.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function
Quality
Job Sub Function
Quality Systems
Job Category
Professional
All Job Posting Locations
Danvers, Massachusetts, United States of America
Job Description
We are searching for the best talent for a Staff Quality Systems Engineer to lead and optimize CAPA and Nonconformance (NC) processes within a regulated medical device environment. This role will be based in Danvers, MA.
Purpose: This role is instrumental in driving quality system improvements, ensuring global regulatory compliance, and mentoring junior engineers. The position includes travel to support cross-site initiatives, supplier quality activities, and audit readiness.
You will be responsible for
- •Lead complex investigations of product and process nonconformances using advanced root cause analysis methodologies (e.g., Fault Tree Analysis, 5 Whys, Fishbone, DOE).
- •Oversee the end-to-end CAPA and NC process, ensuring timely execution, thorough documentation, and effective implementation of corrective and preventive actions.
- •Serve as a subject matter expert (SME) for CAPA and NC processes during internal audits, FDA inspections, and Notified Body assessments.
- •Analyze CAPA/NC trends and metrics to identify systemic issues and recommend strategic quality improvements.
- •Collaborate with cross-functional teams including Manufacturing, R&D, Regulatory Affairs, and Supplier Quality to resolve quality issues and implement sustainable solutions.
- •Support risk management activities in accordance with ISO 14971, including risk assessments related to CAPAs and NCs.
- •Mentor and train junior quality engineers and other stakeholders on CAPA/NC processes, regulatory requirements, and quality tools.
- •Contribute to the development and continuous improvement of the Quality Management System (QMS), including SOPs, work instructions, and templates.
- •Lead or support global harmonization initiatives for CAPA/NC processes across multiple sites or business units.
- •Up to 10% travel may be required to support:
- •Regulatory inspections and internal audits at other facilities
- •Training and collaboration with global teams