Staff Specialist, Windchill PLM
Staff Specialist, Windchill PLM
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Job Description
Staff Specialist Windchill PLM
Portage MI
Stryker is hiring aStaff Specialist Windchill PLMinPortage MIto 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:
- Bachelors 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.
Required Experience:
Staff IC
Employment Type
Full-Time
