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!

The Supplier Quality/Quality Inspection Manager is responsible for cross-functional Quality Assurance, Quality Management/Compliance and activities associated with all Abiomed products and processes with a focus on quality inspections and supplier quality activities in the Danvers plant.

Key Responsibilities:

• Supervise Quality Inspection and Supplier Quality Engineering associates, support quality metrics, reporting and help resolve quality issues.
• Ensure compliance of the quality activities to all applicable quality system regulations
• Lead/manage and assign tasks both long and short term for the Quality Inspection and Supplier Quality Engineering team, including training, development, mentoring, goal setting and budgeting.
• Lead and support MRB activities ensuring appropriate resourcing to minimize value of MRB material and limit part shortages.
• Monitor and analyze production information to support risk management and to provide direction for corrective and preventive actions and/or process improvement activities (CAPA)
• Work cross-functionally to ensure necessary process controls and validations are in place and best practices are followed (GMP)
• Resolve incoming inspection yield issues by driving tighter vendor process capabilities and ensuring appropriate internal drawing tolerances.
• Lead analysis of defective components found in Incoming Inspection and work with suppliers to resolve (SCARs)
• Lead the supplier evaluation process, supplier scorecards and supplier audits. Ensure ASL and supporting documentation required per SOPs is up to date.
• Support internal and external auditing requirements (system compliance)

Job Qualifications:

• BS Degree in a Scientific or Engineering discipline; MS preferred.
• 5+ years of experience in QA/QE in medical device field
• 2+ years managing and leading Quality teams at the company or corporate level.
• Experience with manufacturing of complex products in an ECA, ideally catheter-based or cardiac assist devices preferred.
• Experience with formal problem-solving methodologies and deductive skills
• Experience with handling non-conforming material and assemblies; including root cause investigations pertaining to such non-conformities.
• Knowledge of global quality systems and regulatory requirements (21 CFR Part 11/210/211/820, ISO 13485, Ordinance 169, ISO14971)
• Strong knowledge of GMP, SOPs and quality systems
• Advanced skills with MS Office applications (Word, Excel, Access) and Adobe Acrobat
• Works on multiple assignments in collaboration with various department system owners
• Ability to communicate and work independently with scientific/technical personnel.
• Excellent interpersonal, verbal, and written communication skills are essential.
• Ability to positively influence groups across an organization to embrace a common philosophy.
• Ability to manage and execute on multiple, critical projects simultaneously.
• Strong ethics to escalate issues in the face of competing priorities.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
• Experience with SAP or other ERP system is a plus.

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.