Director, Design Assurance (Implants)

Stryker in Mahwah, NJ

  • Industry: Engineering - Biological And Biomedical Engineer
  • Type: Full Time
position filled
Ensure divisional achievement of quality targets. Provide a strategic direction and tactical focus to the Quality Assurance organization and the Joint Replacement division. Oversee effective utilization and understanding of Quality Assurance systems in our regulated environment. Provide strategic direction to and tactical interaction with Company Global Supply affiliates supplying the Recon division. Provide a platform for process improvement through the training and utilization of Lean/Six Sigma methodologies. Serve as alternate management representative in the absence of Vice President, Design Assurance. Requirements 10+ years related experience in a manufacturing and product development environment Applied knowledge of regulatory requirements, including ISO 9001, ISO 13485, Quality System Regulation and Medical Device Directive Applied knowledge and demonstrated ability to effectively utilize quality data and establish strategy and execution for quality improvements. Demonstrated ability to lead complex projects Demonstrated ability to lead people in a multi-discipline, multi-technology, team-based organization. Demonstrated verbal, written and interpersonal skills Demonstrated ability to lead in a cross-functional team environment and to interact effectively with management from other internal/external functions (e.g., Company Joint Replacement affiliates, other Company Divisions, Company GQO, Company Corporate, and health authorities). Prefer knowledge of lean/Six Sigma methodologies.

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