Staff Specialist, Windchill PLM

Work Flexibility: Hybrid or Onsite

Staff Specialist, Windchill PLM

Portage, MI

Stryker is hiring a Staff Specialist, Windchill PLM in Portage, MI to lead the technical execution, development, and continuous improvement of the Windchill (onePLM) system for our Instruments Division. This role includes mentoring global Business Admins, overseeing Quality Management System (QMS) compliance with medical device regulations, and collaborating with Global Process Owners to implement and maintain quality and regulatory processes across our global systems, all within a fast-paced, innovative environment.

What you will do:

• Mentor and support new change management engineers and business admins.
• Lead and participate in validation activities (IQ, OQ, PQ) and change control processes.
• Manage CAPA and NC actions related to onePLM administration and PLM Help Queue.
• Create and modify Windchill workflows and prioritize tickets with business leads.
• Trend and analyze PLM Help Queue issues using INC tags for continuous improvement.
• Ensure QMS compliance with internal and external regulatory requirements (FDA, ISO, etc.).
• Own configuration of Business Admin QMS procedures and support Management Review forums.
• Drive GMP/GDP practices and liaise with notified bodies for certification changes.

What you will need:

Basic Qualifications:

• Bachelor’s degree in science, engineering, business or related discipline.
• 4+ years of experience in manufacturing environment or equivalent.
• Experience in regulated environment and interaction with regulatory agencies.
• Knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)

Preferred Qualifications:

• Knowledge of the Quality System Regulations (21 CFR Part 820) and ISO 13485 Regulations as it relates to change management.
• Thorough knowledge and understanding of US and International Medical Device Regulations.

Travel Percentage: 10%

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.