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.