Senior Quality Systems Integrator — FDA & ISO Compliance

Stryker Corporation (old); Belfast City District; Hybrid; GBP 35,000 - 58,000; Full time

Benefits offered by this job

Health insurance

Job summary

Stryker Corporation in the United Kingdom is seeking a Senior Quality Systems Specialist to lead QMS integration activities, ensuring compliance with FDA 21 CFR Part 820, ISO 13485, and related global regulations. The role focuses on harmonizing processes, documentation, and controls across both organizations.

The successful candidate will map current-state processes, identify gaps, and define future-state ownership and interfaces while collaborating with Manufacturing, R&D, Quality and

Qualifications

• Level 6 qualification required in science, engineering, business or related field.
• Minimum of 3 years experience in a manufacturing environment or equivalent.
• Experience in regulated environments and interaction with regulatory agencies (FDA/ISO).
• Strong knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning).
• Excellent technical writing and documentation skills.
• Strong communication and influencing skills.
• Ability to plan, organize and implement multiple concurrent tasks.
• Demonstrated cross-functional collaboration and interpersonal skills.
• Analytical and problem-solving capabilities with actionable insights.

Responsibilities

• Assess and document current-state quality system processes across both organisations.
• Map processes and identify gaps in QMS areas (CAPA, Complaints, Document Control, Training, Audits, Management Review).
• Evaluate gaps against regulatory, corporate requirements and integration strategy.
• Define future-state processes including ownership, interfaces and controls.
• Develop, revise and harmonize procedures and templates to support future-state QMS.
• Collaborate with process owners to determine disposition of existing processes and docs.
• Identify compliance risks and potential business impacts of QMS integration.
• Work cross-functionally with Manufacturing, R&D, Quality, Regulatory to implement integrated processes.
• Support verification of QMS changes and ensure effectiveness.
• Facilitate document review, approval, issuance and retirement through EDS.
• Coordinate training for new or revised procedures and roles.
• Transition quality records and content into future-state systems and repositories.

Job description

Stryker Corporation in the United Kingdom is seeking a Senior Quality Systems Specialist to lead QMS integration activities, ensuring compliance with FDA 21 CFR Part 820, ISO 13485, and related global regulations. The role focuses on harmonizing processes, documentation, and controls across both organizations.

The successful candidate will map current-state processes, identify gaps, and define future-state ownership and interfaces while collaborating with Manufacturing, R&D, Quality and