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Skawina, Lesser Poland Voivodeship 00000, Poland
Job details
Work flexiblity: Hybrid or Onsite
Req ID: R526233
Employee type: Full Time
Job category: RAQA
Travel:
Relocation: No
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Job description
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.