Primarily responsible for the oversight & assessment of changes to the quality management system of the Skawina, Poland site. Will oversee and ensure that changes to quality management system processes and procedures are compliant, effective and pose no risk to the quality of the product/processes.
Key Areas of Responsibility
Will work within the QMS team, under general supervision ensures compliance to Change Control processes and procedures and is responsible for, but not limited to:
- Lead & execute the change control board review forums. Participate in multi-site and global forums.
- Liaise with relevant functional groups, facilitate and mentor teams through all stages of the change control process. Supports and coaches the change owners and initiators.
- Acting as change analyst & approver, have responsibility for review and approval changes to processes and procedures, with attention to detail, review for completeness, accuracy, effectivity and appropriateness
- Reviews for sound rationale, challenging justification, correct approval and oversight and resulting status of change requests.
- Ensuring users provide the necessary rigor to the PLM system content including maintaining a live document with all relevant evidence attached, in a timely manner.
- Subject Matter Expert on all related procedures and process SME, ensuring compliance to the relevant Corporate procedures. Super user of PLM system.
- Ensure adequate training is developed, maintained and provided to all users of change control process & systems
- Manage & monitor Skawina site Change Control KPIs including reporting requirements, provide detailed updates and information in support of quality & business review forums, also liaising with other GQO sites to ensure compliance to global requirements & metrics are achieved
- Interface between divisions & GQO sites, and functions /departments such as Design, Quality and Operations in product, process, system, or supplier related changes.
- Identify continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for improvement and optimization of business processes / results.
- Lead &/or participate in cross-plant and corporate project teams in areas of change management and quality systems improvement.
- Lead/coordinate preparation, participate and follow up to Stryker Internal, Corporate and third party compliance audits.
- Lead and manage the document and change control process, change review board, and ensure effective management and approval of product/process changes for the site.
- BS in a science, engineering, or related discipline.
- 6 + years of experience within the medical devices, engineering, manufacturing, or related field required in a regulated industry.
- 2+ 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.
- Strong communication, influencing, and consensus-building skills.
- Analytical ability to draw insights from data and define executable actions.
- Act with a customer service/stakeholder-focused approach.
- 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 820
- MDSAP
- ISO standards (e.g., ISO 13485:2016, ISO 14971:2019)
- Some travel required
Poznaj
Stryker
Stryker to globalny lider na światowym rynku technologii medycznych, który wspólnie ze swoimi klientami dąży do uczynienia opieki medycznej lepszą. Oferujemy szeroką gamę innowacyjnych produktów i usług w zakresie sprzętu medycznego i chirurgicznego, neurotechnologii, ortopedii i kręgosłupa, które poprawiają wydajność leczenia i jakość opieki zdrowotnej.