Senior Manager, Quality Systems Risk Management - Process Owner

Stryker Corporation Portage , MI 49002

Posted 2 weeks ago

Job Description:

Who we want

Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes finding ways to simplify, standardize and automate.

Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

What you will do

Collaborate with Corporate, Division, and Global Quality & Operations leaders and other key business partners on the design and implementation of the company-wide Risk Management processes, including harmonization and alignment across connected and adjacent systems.

  • Provide strategic direction and oversight to the following functions:

  • Company-wide harmonized Risk Management processes and related enabling processes/technologies.

  • Authoritative input for said processes for the Global Quality Manual, QMS planning, and company-wide Management Review processes.

  • Company-wide processes and requirements for assessment of the effectiveness of the Risk Management 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 as it relates to Risk Management.

  • Primary Corporate contact for Corporate Office regulatory and health authority inspections related to Risk Management.

  • Provide active Risk Management mentoring to Division Risk leaders and their management teams.

  • Resolve or elevate issues with effectiveness or efficiency to/through top leadership, including the Corporate, Division, GQO, and SLT teams.

  • Lead the selection, and oversee implementation of, enabling technology to support the processes listed above.

What you need

  • Bachelor's degree in engineering, computer science, software development, life sciences, or related technical discipline.

  • Master's degree preferred.

  • Minimum 10 years of relevant experience in medical device risk 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.

  • Strong leadership, influencing, and negotiation skills. The ability to manage complexity in a cross-functional matrix environment.

  • Proven abilities to successfully interact with the highest levels of leadership, up to the SLT.

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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Senior Manager, Quality Systems Risk Management - Process Owner

Stryker Corporation