Abiomed
Quality Plant Manager - Aachen
Job#: 342952
Positions: 1
Posted: 04/29/2016
Job Type: Full Time
Location: Aachen, Germany
Department: Quality
Salary: Commensurate with Experience
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Job Description

Job Responsibilities:

The Quality Plant Manager is responsible for supporting the supply chain (from supplier management through shipment of product to our customers) and ensuring all operational quality systems are in compliance with Abiomed internal policiesand documentation. Provide leadership to the team and those with whom they interact.

 

Principle 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
  • SAP experience is a plus
  • Six sigma certification is a plus

ABIOMED is an Equal Employment Opportunity/Affirmative Action employer.  We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, veteran status, disability or national origin.

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