Sr. Quality Engineer

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.

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Job Description:

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.

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.

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. 

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.

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The anticipated base pay range for this position is :

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