Sr. Quality Engineer

Johnson & Johnson Co.; Danvers (MA); On-site; USD 79,000 - 128,000; Full time

Job summary

Johnson & Johnson in Danvers, MA, seeks a Sr. Quality Engineer to support operations at the Danvers and Woburn sites. You will drive quality engineering across manufacturing, including nonconformance, CAPA, process validation, and calibration.

The role emphasizes GMP compliance, IQ/OQ/PQ validation, and collaboration across teams to ensure patient safety and product quality. Medical device familiarity is a plus.

Qualifications

• Bachelor’s degree in Engineering or a related field.
• Solid understanding of IQ, OQ, PQ validation processes and GMP compliance.
• Proven ability to work independently and manage multiple tasks.
• Excellent problem‑solving skills and a proactive approach to challenges.
• Strong communication skills with the ability to mentor and lead teams.

Responsibilities

• Develop and maintain quality evaluation and control systems.
• Inspect and test production equipment for precision and accuracy.
• Design inspection processes and analyze testing mechanisms.
• Perform QA tests and statistical analysis to manage product quality risks.
• Lead root cause analysis and CAPA actions.
• Document production nonconformities and coordinate MRB disposition.
• Support CAPA from audits and monitor effectiveness.
• Coach team on non-conformance, corrective actions, and root cause analysis.

Skills

IQ/OQ/PQ validation

GMP knowledge

Problem solving

Communication skills

Mentoring teams

Education

Bachelor’s degree in Engineering

Tools

SAP

CQE certification

Job description

Job Function

Supply Chain Engineering

Job Sub Function

Quality Engineering

Job Category

Scientific/Technology

Job Locations

Danvers, Massachusetts, United States of America, Woburn, Massachusetts, United States of America

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 Description

We are searching for the best talent for a Sr. Quality Engineer, located in Danvers, MA or Woburn, MA.

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.

Purpose: 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.

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.
• 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.

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.

Preferred Skills

• 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.
• Other: Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day‑to‑day interactions with team.

Additional Eligibility and Support

This role is eligible for immigration sponsorship, if required.

Relocation support is not available for this position.

Equal Opportunity Employment

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.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs.

Pay Transparency and Benefits

The anticipated base pay range for this position is : $79,000.00 - $127,650.00

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 period
• 10 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

Company Culture (Reiteration)

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 https://www.jnj.com/.