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Abiomed, part of Johnson & Johnson MedTech, is recruiting for a Senior Manufacturing Quality Engineer located in Danvers, MA. In this role, you will have the unique opportunity to contribute to manufacturing of 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.

• Provide quality engineering support in the development and manufacturing of new and existing medical devices.
• Ensure compliance of manufacturing processes and areas to all applicable quality system regulations.
• Lead Quality reporting such as, key performance metrics, goals, and objectives.
• Lead and support activities related to the Material Review Board.
• 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.
• Monitor and analyze production information to support risk management and provide direction for corrective and preventive actions (CAPA) and/or process improvement activities.
• Validate manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), Test method validations (TMV).
• 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.

• A Bachelor's degree in a relevant Engineering field is necessary.
• 6+ years of experience in QA/QE in the medical device field.
• Experience with manufacturing of complex products in environmentally controlled area, catheter-based or cardiac assist devices preferred. Equivalent experience in the manufacturing of similar products will also be considered.
• Experience with formal problem-solving methodologies and deductive skills.
• Good understanding of FDA QSRs, ISO13485, ISO14971.
• Experience with handling non-conforming material and assemblies, including root cause investigations.
• Experienced in qualification of production equipment and validation of production processes.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

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