Senior Quality Systems Specialist - Integration

About the role

Stryker is looking for a Senior Quality Systems Specialist in Belfast to lead and execute quality system integration activities. The role ensures compliance with FDA 21 CFR Part 820, ISO 13485 and other applicable global medical device regulations, focusing on evaluating, harmonizing and integrating quality system processes, documentation and controls. It is a hybrid position on an 18-month fixed-term contract.

Key responsibilities

• Assess and document current-state quality system processes, procedures, records, roles and controls across both organizations.
• Perform process mapping and gap assessments of QMS areas such as CAPA, complaints, document control, training, audits and management review, then evaluate gaps against regulatory, corporate and business requirements.
• Support the definition of future-state processes, including ownership, roles, interfaces and controls, and develop and harmonize procedures, work instructions, forms and templates.
• Partner with process owners and subject matter experts to decide whether to adopt, revise, consolidate, replace or retire existing processes and documentation.
• Identify compliance risks, dependencies and implementation constraints, and partner with Manufacturing, R&D, Quality, Regulatory and other functions to implement integrated processes.
• Verify that QMS changes have been implemented correctly, and support document review, approval, issuance and retirement through the electronic document management system.
• Collaborate with the Training Team on training for new or revised procedures, and help move quality records and controlled documents into future-state systems.
• Maintain communication with project management and stakeholders, and support internal and external audits with accurate, retrievable documentation.

Required profile

• Level 6 qualification, preferably in Science, Engineering, Business or a related discipline.
• Minimum of 3 years' experience in a manufacturing environment or equivalent preferred.
• Experience in a regulated environment and interaction with regulatory agencies.
• Knowledge of FDA 21 CFR Part 820, ISO 13485 and ISO 14971, and strong knowledge of quality systems (CAPA, audits, management review, quality planning).
• Ability to work in cross-functional teams, plan multiple concurrent tasks and communicate up, down and across the organization.

Required skills

• Technical writing and documentation skills.
• Strong communication, negotiation and influencing skills.
• Analytical and problem-solving abilities.
• Basic Microsoft Office, MS Project and Adobe Acrobat.

What we offer

• Salary range in the UK of £35,000 to £58,400 per year, with possible incentive compensation.
• Comprehensive benefits package.
• Hybrid working arrangement.