Work Flexibility: Hybrid

Primarily responsible for the strategic development of the Skawina, Poland site quality management system (QMS) in accordance with applicable ISO standard(s), regulations including Stryker Corporate and divisional procedures. This individual will develop & lead the QMS, Document Control, Change Management, and NC/CAPA processes at this site.

Key Areas of Responsibility

Will work within the site’s QMS structure, with responsibility to ensure an effective and efficient QMS is built and maintained, which includes, but not limited to:

Responsible for the development, maintenance, and improvement of QMS policies and procedures.Ensure QMS reflects actual activities, business needs and supports new product development (NPD) and product transfer requirements.Manage QMS activities to support achievement of project milestones, applicable to the site.Assist in the on boarding training of other QMS specialist within the quality management system of the Skawina site and Stryker’s procedures.Liaise with notified bodies to attain, maintain and manage certification changes, if any.Coordinate the preparation, participation and follow-up for Stryker internal, Corporate, and third party audit / inspection activities.Ensure management review(s), quality review(s) are performed as per QMS requirements.Maintain a high level of QMS awareness across Stryker and medical device industry. Interpret applicable regulations such as FDA, ISO and Stryker policies.Support development of QMS training curricula and programs.Ensure the QMS key process indicators (KPIs) are reviewed and updated as per defined interval.Perform trend analysis of the QMS key performance indicators to identify areas for improvement.The Staff QMS Specialist must be able to work independently under general supervision with considerable latitude for initiative and independent judgment.

Qualifications Knowledge Skills

BS in a science, engineering, business, or related discipline. Master’s degree or equivalent preferred. 6+ years of experience within the medical devices, engineering, manufacturing, or related field required in a regulated industry.Strong Relationship, problem solving, continuous improvement, data management, and training skills.Proven ability to be self-directed, self-motivated, and able to prioritize and resolve competing demands and priorities required.Expert working knowledge of regulatory requirements, standards, and regulations.Strong communication, influencing, and consensus-building skills.Analytical ability to draw insights from data and define executable actions.Experience in developing, implementing, and/or improving Quality System processes, procedures, and/or electronics systems.Working knowledge of, and experience with the following regulations/standards preferred:21 CFR Part 820MDSAPISO standards (e.g., ISO 13485:2016, ISO 14971:2019)Good to have TrackWise.

Travel Percentage: 10%