Manufacturing 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 Med Tech, 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.

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Supply Chain Engineering

Quality Engineering

Scientific/Technology

Danvers, Massachusetts, United States of America

We are searching for the best talent for a Manufacturing Quality Engineer I to be based in Danvers, MA. This role is part of the Abiomed group of Johnson & Johnson and will contribute to the manufacturing of life‑saving medical devices. You will play a crucial role in ensuring the highest quality standards are met to save lives and recover hearts.

• Provide quality engineering support in the development and manufacturing of new and existing medical devices.
• Ensure compliance of manufacturing processes and areas with all applicable quality system regulations.
• Support non‑conformance investigations, including cause analysis, documenting findings, and approving material dispositions. Promptly address quality concerns through corrections, corrective/preventative actions, and escalations.
• Validate manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and test method validations (TMV).
• Collaborate with manufacturing engineering to implement necessary process controls and validations in alignment with industry standards (GMP).
• Support the Quality Management System by developing, creating, and editing SOPs.

• A bachelor’s degree in a related engineering field is preferred.
• Experience with formal problem‑solving methodologies and deductive skills.
• Good understanding of FDA QSRs, ISO
  13485, ISO
  14971.
• Experience with root‑cause investigations.

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, please email the Employee Health Support Center (ra-) or contact AskGS to be directed to your accommodation resource.

Customer Centricity, Data Savvy, Document Management, Execution Focus, Good Automated Manufacturing Practice (GAMP), Issue Escalation, Lean Supply Chain Management, Process Control, Process Improvements, Quality Control (QC), Quality Services, Quality Standards, Quality Systems Documentation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy

$65,000.00 – $

• Vacation – 120 hours per calendar year
• Sick time – 40 hours per calendar year (48 hours for Colorado residents, 56 hours for Washington residents)
• 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 visit