Document QMS Controller

September 19, 2024

Stryker

Skawina

OTHER

We are excited to be named one of the World’s Best Workplaces by Fortune Magazine!
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.

Will work within the QMS team, under general supervision, ensures compliance to Document Control and QMS processes and procedures and is responsible for, but not limited to:

Document Control responsibilities:

Responsible for activities related to document routing, distribution and release to assure that the latest effective documents are available as required.
Ensure prompt archiving, storage and timely retrieval of documents and information, as needed to complete investigations, audits and/or reports.
Excellent knowledge of document control process, revise and update procedures to improve practices and systems as per current best practices.
Drive implementation of external Stryker documents to local QMS, be the single point of contact for Skawina site.

QMS responsibilities:

Contribute in developing optimum future state of QMS for business needs, aligned with Corporate, Divisional & Skawina QMS.
Support management review and quality planning review & other forums.
Support, develop and deliver training on compliance and overall QMS requirements to various departments in Skawina site.
Support and participate in internal, Corporate and third party compliance audits.
Lead or collaborate with NC/CAPA investigations related to findings derived from Internal or external audits.
Support and communicate with notified bodies to manage change notification for Skawina site certification(s).
Liaise with relevant functional groups, facilitate and mentor teams through all stages of the document control and QMS processes.
Support & monitor Skawina site document control and QMS KPIs and provide detailed updates in various quality & business review forums.

Qualifications:

BS in a science, engineering, or related discipline.
1+ years of experience within the medical devices, engineering, manufacturing, or related field required in a regulated industry.
1+ year of experience in document control or quality system areas.
Must possess strong leadership, project management and presentation skills.
Strong Relationship, problem solving, continuous improvement, data management, and training skills.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Med Surg, 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.

We regret to inform you that this job opportunity is no longer available