New · posted Nov 5
Johnson & Johnson · Medical Devices
Staff Quality Systems Engineer
- Danvers, MA
- On-site
- Full-time
- Senior & Principal
The role
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.
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
What you need
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 ([email protected]) or contact AskGS to be directed to your accommodation resource.
Pay and benefits
$96,000 – $155,250 a year
Employer providedThe anticipated base pay range for this position is
$96,000.00 - $155,250.00
Retirement pension plan and 401(k) savings plan
Vacation (120 hours per year)
Sick time
13days
Holiday pay (13 days per year)
Parental leave (480 hours)
Bereavement, caregiver and volunteer leave
Where you'll work
Danvers, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Danvers, MAWorking conditions
Job Function
Quality
Job Sub Function
Quality Systems
Job Category
Professional
All Job Posting Locations
Danvers, Massachusetts, United States of America
Equal opportunity, accessibility and legal noticesJohnson & Johnson's statements, word for word
Additional Description for Pay Transparency
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Job intelligence
The context around this role
Live data · November 5, 2026
Salary intelligence
How the pay compares
This role's midpoint is 7% above the US median for Quality Systems & Document Control roles at this level.
This roleEmployer provided
Senior & Principal roles in the US21 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $96,000 | — | $155,250 |
| All US (middle half) | $97,000 | $117,000 | $125,500 |
This role: Johnson & Johnson's own published range. Comparisons: the base pay employers published on open Quality Systems & Document Control roles at the same level on Regulatory Jobs, November 5, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Systems & Document Control
The general path across 81 open Quality Systems & Document Control roles on Regulatory Jobs, with the titles they carry most. Not Johnson & Johnson's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership9
- Investigations and CAPA8
- Quality systems and risk8
- GMP and compliance4
- Lab testing and methods3
- Documentation and SOPs2
- Regulatory submissions1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Systems & Document Control work in medical devices, led by the seven this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485Named in the posting
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devicesNamed in the posting
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devicesNamed in the posting
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilanceNamed in the posting
- Health CanadaCanada Medical Devices Regulations(official source, opens in a new tab)Health Canada's licensing and quality requirements for medical devices (SOR/98-282)Named in the posting
- PMDAJapan PMDA(official source, opens in a new tab)Japan's Pharmaceuticals and Medical Devices AgencyNamed in the posting
- TGAAustralia TGA(official source, opens in a new tab)Australia's Therapeutic Goods AdministrationNamed in the posting
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- FDAMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program shared by five regulators
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID database
- ISOISO 9001(official source, opens in a new tab)Quality management systems requirements
Company hiring pulse
Johnson & Johnson on Regulatory Jobs
- 39
- Open roles
- 39
- Distinct roles
- 17
- Locations
By discipline
- Quality20 51%
- Clinical11 28%
- Regulatory8 21%
By level
- Senior & Principal13 33%
- Manager12 31%
- Director7 18%
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Staff Quality Systems Engineer at Johnson & Johnson
Applications close November 14. $96K–$155K a year, employer provided.