• Staff Specialist, Windchill PLM

    Stryker (Portage, MI)


    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.

     

    Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

     

    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.