Director, Design Assurance (Implants) in Mahwah, NJ at Stryker Corporation

Date Posted: 11/30/2019

Job Snapshot

Job Description

The Director, Design Assurance (Implants) will lead a team to ensure Stryker Joint Replacement has a suitable, adequate and effective quality management system by overseeing the division’s Design Assurance and Quality Systems functions.  This leader's focus will be on New Product Development, Sustaining Engineering, Patient-Specific Solutions, and Product Sterility/Biocompatibility.

Primary Responsibilities:

  • 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 Stryker 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., Stryker Joint Replacement affiliates, other Stryker Divisions, Stryker GQO, Stryker Corporate, and health authorities).
  • Prefer knowledge of lean/Six Sigma methodologies. 

Work From Home: Occasional

Travel Percentage: 20%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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