The Quality Plant Manager is responsible for supporting the supply chain (from supplier management through shipment of product to our customers) and ensuring all production and supplier related activities are in compliance with Abiomed internal policies and documentation. Provide leadership to the team and those with whom they interact.
Primary Duties and Responsibilities:
Manage Manufacturing and Supplier Quality Engineering and support supplier quality metrics, reporting and help resolve supplier quality issues
Lead and support MRB activities ensuring appropriate resourcing to minimize value of MRB material and limit part shortages
Lead internal audits or production, including all environmental and finished goods; external audits of suppliers and SCAR activities, when needed
Qualify new suppliers with Manufacturing Supplier Engineering group
Develop and improve existing quality data systems for suppliers and production and provide regular quality data for the plant
Ensure the company has risk-based decision making quality processes in place when needed to perform this function
Support all obsolescence programs with respect to suppliers
Skills/Requirements
Job Qualifications:
BS in engineering or life sciences field; Masters preferred
Proficient knowledge and application of global medical device regulations: QSR/GMP/GCP/ISO/PMDA
Minimum of 10 years Quality Assurance / Quality Systems experience in the medical device industry
Minimum of 3 years in quality management, managing/leading teams
Medical device manufacturing experience required
Prior QA factory support experience in environmental monitoring and QA supplier management
Working knowledge and practical application of 21 CFR Part 820, ISO 13485 and ISO 14971
Experience with US FDA, PMDA and EU regulated companies
Superior analytical, statistical and communication skills (written, verbal and presentation)
Professional presence, articulate, experienced
Demonstrated application of strong statistical technique skills and engineering mindset
