Johnson & Johnson is seeking a Manufacturing Quality Engineer to ensure the highest quality standards are met for life-saving medical devices, specifically the Impella heart pump and its associated sensors and optical benches, manufactured at their Danvers and Woburn, Massachusetts facilities.
Requirements
- Minimum of 4 years of experience in quality, preferably in the medical device manufacturing industry.
- Experience in medical device industry working under FDA regulations (21 CFR part 820), ISO 13485 and EU MDR.
- Solid understanding of IQ, OQ, PQ validation processes and GMP compliance.
- Working knowledge of SAP preferred.
- Knowledge of electrical systems, Schematic drawing and IPC 610 is a plus.
Responsibilities
- Document production non conformity, 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.
- Confers with team members on process validations for current and new Quality Engineering processes for subsequent operational integration and supply chain implementation.
- 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)
Other
- Bachelor's degree in engineering or a related field. The typical engineering degree requirement is waived for candidates with +6 years of experience in quality role.
- 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.
- Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.
