Work Flexibility: Hybrid or Onsite

Support the development of the quality management system in accordance with relevant regulatory requirements for medical devices.
Oversee, support, and ensure that an effective and efficient quality management system is built and maintained. Responsibility for ensuring
that all applicable quality system regulations are met in order to receive regulatory clearance/certification.

What you will do:

Supports QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, MDD, and individual country requirements).Engage in the development of optimum future state of QMS for business needs.Identify improvements and inputs into the quality planning process.Execute development and/or modification of Stryker's QMS.Support Management Review and Quality Planning Review and related forums.Assess and quantify requirements for QMS requirements to optimize structure.Support GMP and GDP within Quality organization.Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS.Support QMS training development and delivery.Contribute to the development, maintenance, and improvements of policies and procedures.Support implementation of best-in-class practices and benchmark against industry leaders and regulatory requirements.Support notified body communication.Ensure QMS reflects actual activities, business needs and supports NPD requirement.Participate in relevant QMS IS discussions.Basic project management understanding.Key contributor to QMS business process(es) and understand IS system support requirements.Support internal and external quality system audits.Understands system integration.Support IS change control assessment and approval.

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What you will need:

Level 8 qualification in an Engineering, Science or business related discipline0-2 years experience

Travel Percentage: None