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Abiomed, part of Johnson & Johnson MedTech is recruiting for a highly-motivated Manufacturing Quality Engineer II based in Danvers, MA. 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 the highest quality standards are met to save lives and recover hearts.

Responsibilities:

• 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.
• Support non-conformance investigations, including cause analysis, documenting findings, and approving material dispositions. Promptly address any 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), test method validations (TMV).
• Collaborate with manufacturing engineering to ensure the implementation of necessary process controls and validations in alignment with industry standards (GMP).
• 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 related Engineering field.
• 2+ years of experience in QA/QE in the medical device field.
• 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.

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.