New · posted Oct 23
Johnson & Johnson · Medical Devices
Sr. Quality Engineer
- Danvers, MA +1 more
- On-site
- Full-time
- Senior & Principal
Closes Oct 29, 2026 · 7 days left
The role
In this role, you will have the unique opportunity to contribute to the manufacturing of life-saving medical devices. As part of our "Patients First!" culture, you will play a crucial role in ensuring that high standards of product quality, compliance, and patient safety are maintained.
This individual will be a member of the Quality organization, primarily supporting operations at the Danvers, MA site, with additional support for the Woburn, MA site. The Sr. Quality Engineer will provide Quality Engineering support across manufacturing and quality operations, including areas such as production, incoming inspection, nonconformance management, equipment and calibration, process validation, and other Quality functions as business needs and priorities require.
The successful candidate must be comfortable working across functional boundaries and adapting responsibilities to support changing operational and Quality priorities.
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 Sr. Quality Engineer, located in Danvers, MA or Woburn, MA.
A pre-identified candidate for consideration has been identified. However, all applications will be considered.
You will be responsible for
Developing, modifying, applying and maintaining quality evaluation and control systems/protocols. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs and analyzes inspection and testing processes, mechanisms and equipment. Conducts quality assurance tests and performs statistical analysis to assess the level of control and manage product quality risks. Undertakes root cause analysis of incidents requiring corrective action.
This individual will need to be able to support both the Danvers and Woburn sites.
- Document production nonconformity, conduct investigation, assess product risk, recommend disposition in collaboration with other members of MRB.
- Define and implement action plans and effectiveness monitoring for CAPA originated from Internal/external audits .
- Coaches team members regarding any Quality Engineering non-conformance, subsequent corrective, and preventive actions, by documenting, investigating, and conducting root cause analysis, and successfully implementing corrective actions.
- Ensures timely escalation of any Quality Engineering issues or concerns to the next management level.
- Identifies, under limited supervision, any Quality Engineering non-conformance, subsequent corrective, and preventive actions, by documenting, investigating, and conducting root cause analysis, and successfully implementing corrective actions.
- Support process validations/revalidation on current and new processes. (IQ, OQ, PQ)
- Support incoming inspection department as needed.
- Collaborate with equipment department for PM and calibration procedural updates. Support for non-conformities from failed calibration, etc.
Other
- Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.
- This role is eligible for immigration sponsorship, if required. Relocation support is not available for this position.
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, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.
What you need
Qualifications/Requirements
- Bachelor’s degree in Engineering or a related technical field and 2–4 years of relevant Quality Engineering or related experience.
- Solid understanding of IQ, OQ, PQ validation processes and GMP compliance.
- Proven track record to work independently and manage multiple tasks effectively.
- Excellent problem-solving skills and a proactive approach to challenges.
- Strong communication skills, with the ability to mentor and lead teams effectively.
Preferrednice to have
- Working knowledge of SAP.
- Preferred certifications: ASQ Certified Quality Engineer (CQE).
- Knowledge of electrical systems, Schematic drawing and IPC 610 is a plus.
- Experience in medical device industry working under FDA regulations (21 CFR part 820), ISO 13485 and EU MDR. ISO 13485 Internal audit certificate is a plus.
Pay and benefits
$79,000 – $127,650 a year
Employer providedThe anticipated base pay range for this position is
$79,000.00 - $127,650.00
Pension and 401(k) savings plan
Vacation (120 hours per year)
Sick time
Holiday pay (13 days)
Parental leave
Immigration sponsorship eligibility
Where you'll work
Danvers, MA +1 moreOn-siteOpen in Maps (opens in a new tab)
Also posted for: Woburn, MA
More jobs in Danvers, MA +1 moreWorking conditions
Job Function
Supply Chain Engineering
Job Sub Function
Quality Engineering
Job Category
Scientific/Technology
All Job Posting Locations
Danvers, Massachusetts, United States of America, Woburn, Massachusetts, United States of America
From the posting
About Johnson & Johnson
About MedTech
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
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 · October 23, 2026
Salary intelligence
How the pay compares
This role's midpoint is 13% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in Massachusetts27 roles publishing pay
Senior & Principal roles in the US313 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $79,000 | — | $127,650 |
| Massachusetts (middle half) | $106,250 | $124,000 | $133,000 |
| All US (middle half) | $102,500 | $119,000 | $137,500 |
This role: Johnson & Johnson's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 23, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 927 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Johnson & Johnson's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 29 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance7
- Investigations and CAPA7
- Documentation and SOPs5
- Collaboration and leadership5
- Validation and qualification3
- Lab testing and methods1
- Regulatory submissions1
- Quality systems and risk1
- Data and digital systems1
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
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
Company hiring pulse
Johnson & Johnson on Regulatory Jobs
- 39
- Open roles
- 38
- Distinct roles
- 19
- Locations
By discipline
- Quality24 62%
- Regulatory13 33%
- Compliance & Safety2 5%
By level
- Senior & Principal13 33%
- Associate & Specialist12 31%
- Manager10 26%
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Sr. Quality Engineer at Johnson & Johnson
Applications close October 29. $79K–$128K a year, employer provided.