Senior 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

At Abiomed, part of Johnson & Johnson, we are currently seeking a highly skilled and motivated individual to join our team as a Sr. Manufacturing Quality Engineer to support our capital products line (Automated Impella Controller). In this role, you will have the unique opportunity to contribute to manufacturing life‑saving medical devices. As part of our "Patients First!" culture, you will play a crucial role in ensuring the highest quality standards are met to save lives and recover hearts.

This position will be located in Danvers, MA.

• Provide quality engineering support in the development and manufacturing of new and existing capital products
• Ensure compliance of manufacturing processes and areas to all applicable quality system regulations
• Lead Quality reporting such as, key performance metrics, goals, and objectives for capital products
• Lead and support activities related to the Material Review Board for capital products
• Lead non‑conformance investigations, including cause analysis, documenting findings, and approving material dispositions. Promptly address any quality concerns through corrections, corrective/preventative actions, and Escalations for capital products
• Update and maintain risks management files including PFMEA
• Monitor and analyze production information to support risk management and provide direction for corrective and preventive actions (CAPA) and/or process improvement activities for capital products
• Validate manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), Test method validations (TMV) for capital products
• Collaborate with manufacturing engineering to ensure the implementation of necessary process controls and validations, while adhering to established guidelines (GMP)
• Support process optimization using design of experiments (DOE) and retrospective data analysis to understand and minimize sources of process variation affecting products. Identify key process input variables and key process output variables
• Support Quality Management System (process development, creating and editing new and existing SOPs). Support internal and external auditing requirements in manufacturing for capital products

A minimum of Bachelor's or equivalent University degree is required with a focus in engineering or a related field preferred.

• Experience in medical device industry working under FDA regulations (21 CFR part 820), ISO 13485 and EU MDR.
• Experience with formal problem‑solving methodologies and deductive skills.
• Good understanding of FDA QSRs, ISO
  13485, ISO
  14971.
• 6+ years of experience in QA/QE in the medical device field.
• Experienced in qualification of production equipment and validation of production processes.
• Experience with handling non‑conforming material and assemblies, including root cause investigations.
• Highly preferred:
  • Experience with manufacturing capital equipment that is software enabled. Equivalent experience in the manufacturing of similar products will also be considered.
  • ASQ CQE certification is a plus
  • Degree in Software or Electrical engineering is a plus
  • ISO 13485 Internal audit (or lead Auditor) certificate is a plus.
  • Experience working with electrical medical devices
  • Understanding and experience with IEC 62304 software life cycle

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive…