Sr. Quality Engineer

NCSL International; 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 the manufacturing of life-saving medical devices. Based in Danvers or Woburn, you will uphold high quality standards, compliance and patient safety across functions.

Responsibilities include CAPA, audits, nonconformances, root cause analysis, and coordinating with equipment and incoming inspection. The role requires a Bachelor's in Engineering and 2–4 years of Quality Engineering experience, with GMP and FDA/regulatory

Qualifications

• Solid understanding of IQ, OQ, PQ validation processes and GMP compliance.
• Ability to work independently and manage multiple tasks.
• Excellent problem-solving and proactive approach to challenges.
• Strong communication skills and ability to mentor and lead teams.

Responsibilities

• Document production nonconformity, investigate, assess risk and disposition with MRB.
• Define and implement CAPA plans and effectiveness monitoring from audits.
• Coach team on quality non-conformance, root cause analysis, and corrective actions.
• Escalate quality issues to management promptly.
• Identify non-conformances under limited supervision and implement corrective actions.
• Support process validations/revalidation (IQ/OQ/PQ).
• Support incoming inspection as needed.
• Collaborate with equipment team on PM and calibration updates, and address non-conformities.

Skills

Quality Engineering

Problem solving

Communication

Leadership

Education

Bachelor's degree in Engineering or related field

Tools

SAP

Job description

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

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

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. 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.

You will be responsible for

The successful candidate must be comfortable working across functional boundaries and adapting responsibilities to support changing operational and Quality priorities.

• 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

• 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.
• This role is eligible for immigration sponsorship, if required. Relocation support is not available for this position.

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. 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.

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 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