Abiomed
Quality Engineering Manager
Job#: 281109
Positions: 1
Posted: 06/23/2015
Job Type: Full Time
Location: Danvers, MA
Department: Quality
Salary: Commensurate with Experience
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Job Description

Job Responsibilities:

The Quality Engineering Manager is responsible for supporting new programs, manufacturing, and other sustaining/maintenance activities with regard to the quality engineering function.

Primary Duties and Responsibilities:

  • Develop, implement, and improve new and existing product quality requirements
  • Support quality engineering in product development, including design control and risk management
  • Lead cross-functional teams to perform and maintain risk assessments
  • Oversee and direct quality engineering processes/results with senior program managers and functional managers to support all sustaining activities including manufacturing quality, CAPA, supplier quality, and complaint handling
  • Develop, improve and maintain existing company quality objectives, track and trend performance
  • Manage long and short term planning for the Quality Engineering team, including training, development, and goal-setting.
  • Design and implement process improvements for the Quality Engineering function, including design controls, risk management, problem solving, root cause analysis and the application of statistical methods
  • Ensure robust processes are employed in new product development




Skills/Requirements

Job Qualifications:

  • Masters degree in sciences and engineering plus 8 years of experience in medical device industry with 3 years in quality management or Bachelors degree in sciences or engineering and 10 years of same experience
  • Must have ASQ certifications in CQE or CSSBB. Demonstrated application of strong statistical technique skills and engineering mindset;
  • Working knowledge and practical application of CFR Part 820, FDA GMP/GLP, MDD, ISO, AAMI, and CEN.
  • Superior analytical, statistical, and communication skills (written, verbal and presentation).
  • SAP experience (Quality Module), and Managing international teams a plus
  • Adept at creating and communicating a clear vision among team members and the company and effectively aligning resources to achieve department and company goals.
  • Skilled at addressing management and influencing senior level leaders regarding matters of significance to the organization.
  • Ability to effectively prioritize and manage multiple activities and responsibilities.

ABIOMED is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Veteran/Disabled.

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