Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed’s “Patients First!” culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.

I Am Abiomed | I Am Heart Recovery | Patients First!

Job Responsibilities:

The Sr Quality Systems Engineer is responsible for supporting the Quality Assurance organization and ensuring compliance of the Quality Management System (QMS). This position is responsible for integrating and maintaining quality management systems and providing quality system support for the Danvers site. This position will be primarily responsible for managing the CAPA program for the entire organization.

Principle Duties and Responsibilities :

• Must have in depth knowledge of and ability to apply quality system regulation, including QSR, ISO 13485, MDSAP and MDD/MDR.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities.
• Contribute to the development of Quality System performance measures, data collection, trending, and reporting.
• Assures that data obtained during all quality activities is complete, accurate and documented consistently with company policies and procedures.
• Lead and Manage Corrective and Preventive Action (CAPA) program and improve the CAPA system efficiency as necessary.
• Support and/or lead 3rd party audits, including follow-up on actions. Lead Back Room, communicate and coordinate associated activities across the organization.
• Support Internal Audit program, e.g., participate/lead Internal audits, follow up on the finding with auditee through effective closure, present the data for trending, etc.
• Ensure compliance of QMS through authoring and updating Standard Operating Procedures (SOP).
• Establish and support to Abiomed global training program.
• Support New Product Development projects, as needed.
• Other Duties as assigned.

Qualifications

Job Qualifications:

• BS degree in Regulatory Affairs, Clinical Assurance, Life Sciences or related field. MS preferred.
• Lead Auditor Certification highly preferred.
• 5+ years Quality Assurance / Quality Systems experience in an FDA-regulated industry (Medical device).
• Must be proactive and able to work independently with minimal supervision; strong collaboration skills are essential.
• Knowledge and application of QSR/GMP/GCP/ISO regulations as related to medical device manufacturing.
• Working knowledge and practical application of 21 CFR Part 820, ISO 13485, and ISO 14971.
• Strong analytical and statistical skills.
• Ability to Communicate ideas and information clearly, effectively, and frequently (oral and written).
• Ability to exercise judgment to determine methods, techniques, and evaluation criteria for obtaining results.
• Able to work in a fast-paced work environment, prioritize tasks and manage multiple projects at once.

Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.