Director, Quality Systems – Design Controls Lead - Portage, MI - Stryker Corporation

Date de publication : 6/26/2019

Résumé de l'offre

Description de l'offre

Responsible for setting the direction for our company-wide practices and processes for Design Controls.  This person also leads the architecture, planning, management, and implementation of said systems.  This individual is considered the company’s primary subject matter expert that represents Stryker in industry groups and with global regulatory agencies to influence industry practice and to ensure Stryker is fully in compliance with global practices, regulations, and standards.  This leader also selects, develops, and guides Global and Division Process Owners for instilling the company-wide processes across Stryker and at each design division and location.  This person may have direct reports representing specific areas of company-wide engineering practice.

  • Collaborate with senior Corporate, Division, Global Quality, and Engineering leadership and other key stakeholders on the design and implementation of the company-wide Design Controls processes, including boundaries for harmonization and alignment.
  • Provide strategic direction, oversight, and governance for the following Corporate Engineering functions:
    • Company-wide harmonized Design Control processes, including product security and software design, and related enabling processes/technologies.
    • Governance and oversight for said processes within the Global Quality Manual, QMS planning, and company-wide Management Review processes.
    • Company-wide processes and requirements for assessment of the effectiveness of the Design Control processes.
    • Metric analysis and reporting related to assuring the effectiveness of these processes and support of related functions.
    • Leading expert for assessment of M&A targets, integrations, and post-integration remediation actions.
    • Primary Corporate point of contact for Corporate Office regulatory and health authority inspections.
  • Partner with senior Division R&D leadership and their management teams.
  • Provide active Design Controls leadership and coaching to Global Process Owners.
  • Resolve or elevate issues with effectiveness or efficiency to/through senior leadership, including the R&D Council, RAQA Heads, and senior GQO QA and AO leaders.
  • Lead the selection, and oversee implementation of, enabling technology to support the processes listed above.
  • Bachelor’s degree, minimum, in Engineering, computer science, software development, life sciences, or other related technical degrees.
  • Master’s degree in Engineering or Engineering Management preferred.
  • Minimum 15 years of relevant experience in medical device design, development, and management.
  • Minimum 5 years of Design Engineering management.
  • Experience in multi-divisional program/project design leadership strongly preferred.
  • Extensive experience in designing and implementing Quality System processes in support of devices governed by the FDA, ISO, and other regulatory authorities.
  • Experience with product security and software design required.
  • Experience with IS systems (programming, technology management, electronic document management systems, and software validation) preferred.
  • Technical writing skills specific to a regulated compliance environment.
  • Strong leadership, influencing, and negotiation skills.  The ability to manage complexity in a cross-functional matrix environment.
  • Excellent written and oral communications and interpersonal relationship skills.
  • Proven abilities to successfully interact with the highest levels of leadership, up to the SLT.
  • Will be required to lead resolution of complex, multi-variate problems and situations in diverse cultures and teams.

Work From Home: No

Travel Percentage: Up to 25%

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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