Senior Quality Systems Specialist Integration

**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

#IJ

United Kingdom Pay Ranges:

• United Kingdom: 35000 - 58400 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 addition to base salary this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable) along with Strykers comprehensive benefits package.

If youd 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.