Staff Specialist, Windchill PLM - Stryker Corporation : Job Details

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 one. PLM 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 . 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...Specialist, Staff, Healthcare, Manufacturing, Management, Business