Work Flexibility: Hybrid
**18 month fixed term contract**
Position Summary
The Senior Quality Systems Specialist is responsible for leading and executing quality system integration activities to ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable global medical device regulations. This role focuses on evaluating, harmonizing, and integrating quality system processes, documentation and controls.
Key Areas of Responsibility
- Assess and document current-state quality system processes, procedures, records, roles, responsibilities, and controls across both organizations.
- Perform process mapping and detailed gap assessments across applicable QMS processes, including CAPA, Complaints, Document Control, Training, Audits, Management Review, and other relevant quality system areas.
- Evaluate identified gaps against applicable regulatory requirements, corporate requirements, business needs, and the approved QMS integration strategy.
- Support the definition and documentation of future-state processes, including process ownership, roles, responsibilities, interfaces, and required controls.
- Develop, revise, and harmonize procedures, work instructions, forms, templates, and related quality system documentation to support the approved future-state QMS.
- Partner with process owners and subject matter experts to determine appropriate disposition of existing processes and documentation, including adoption, revision, consolidation, replacement, or retirement.
- Identify compliance risks, process dependencies, implementation constraints, and potential business impacts associated with QMS integration activities.
- Partner cross-functionally with Manufacturing, R&D, Quality, Regulatory, and other business functions to implement sustainable and compliant integrated processes.
- Support verification of QMS changes to confirm that approved requirements have been implemented and that the resulting processes are effective.
- Facilitate document review, approval, issuance, and retirement activities through the applicable electronic document management system.
- Collaborate with the Training Team and process owners to develop and implement training for new or revised procedures, roles, and compliance expectations.
- Support the transition of applicable quality records, controlled documents, and other QMS content into the approved future-state systems and repositories.
- Maintain effective communication with project management, process owners, and key stakeholders regarding decisions, risks, resource needs, and roadblocks.
- Ensure integration activities maintain ongoing compliance with FDA requirements, ISO 13485, MDSAP, EU MDR, and other applicable regulatory and quality system requirements.
- Support integration-related internal and external audits by providing accurate, complete, and retrievable documentation and objective evidence.
Qualifications
- Level 6 qualification required, preferably in a Science, Engineering, Business or related discipline.
- Minimum of 3 years experience in manufacturing environment or equivalent preferred.
- Experience in regulated environment and interaction with regulatory agencies
Knowledge
- Understanding of FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
- Strong knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)
- Excellent technical writing and documentation skills.
- Strong communication and influencing skills.
- Ability to plan, organize, and implement multiple concurrent tasks.
- Strong interpersonal skills, written, oral communication and negotiations skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.
- Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.
- Demonstrated ability to work in cross-functional team environments.
System/Computer Requirements:
- Basic Microsoft Office, MS Project, Adobe Acrobat
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United Kingdom Pay Ranges:
- United Kingdom: £35,000 - £58,400 GBP Annual
At Stryker, we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the role. In addition to base salary, this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable), along with Stryker’s comprehensive benefits package.
If you’d like to learn more about the salary or the benefits associated with this role, your recruiter will be happy to walk you through the details as you progress through the hiring process.
Travel Percentage: None