Senior Quality Systems Specialist

Stryker Corporation; Belfast; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A leading medical device company in Belfast is seeking a Senior Quality Systems Specialist to lead quality system improvement activities and ensure compliance with FDA and ISO regulations. The ideal candidate will have at least 3 years of experience in a manufacturing environment, strong knowledge of quality systems, and excellent communication skills. Key responsibilities include mapping existing processes, supporting audits, and collaborating with various teams to implement improvements. This role offers a hybrid work flexibility.

Qualifications

• Minimum of 3 years experience in a manufacturing environment or equivalent preferred.
• Demonstrated ability to work in cross-functional team environments.
• Ability to plan, organize, and implement multiple concurrent tasks.

Responsibilities

• Lead improvement projects related to quality system opportunities.
• Map existing quality processes to identify improvement priorities.
• Partner cross-functionally to implement sustainable quality improvements.
• Support internal and external audits by providing documentation.

Skills

Experience in regulated environment

Understanding of FDA 21 CFR Part 820

Strong knowledge of Quality Systems

Excellent technical writing skills

Strong communication skills

Education

Level 6 qualification in Science, Engineering, or Business

Tools

Microsoft Office

MS Project

Adobe Acrobat

Job description

Senior Quality Systems Specialist page is loaded## Senior Quality Systems Specialistlocations: Belfast, United Kingdomtime type: Full timeposted on: Posted Todayjob requisition id: R554474Work Flexibility: HybridJoin our team in Belfast as a Senior Quality Systems Specialist!**Position Summary**The Senior Quality Systems Specialist is responsible for leading and executing quality system improvement 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 improving existing quality system processes, documentation, and controls to address opportunities for improvement identified through internal assessments and audits.**Key Areas of Responsibility*** Lead improvement projects related to quality system opportunities identified through internal assessments and audits.* Map and gap-analyze existing quality processes (CAPA, Complaints, Design Controls, Document Control, etc.) to identify improvement priorities.* Assess and revise quality procedures, work instructions, and forms to ensure alignment with regulatory requirements and corporate requirements, ensuring alignment with the organization’s quality system harmonization strategy.* Identify, initiate and own Nonconformances to address systemic compliance issues.* Partner cross-functionally with Manufacturing, R&D, Quality and Regulatory to implement sustainable quality improvements.* Support verification of quality system changes, ensuring effective implementation and ongoing compliance.* Facilitate document change review and approval through electronic document management system.* Collaborate with Training Team to establish training on revised quality system procedures and compliance expectations.* Track and report progress, key metrics, and issues related to quality system harmonization and improvements.* Ensure continued and effective communication with project management and stakeholders of key decisions, risks and roadblocks.* Ensure ongoing compliance with FDA, ISO 13485, MDSAP, and EU MDR throughout integration efforts.* Support internal and external audits by providing documentation and ensuring records are complete, accurate, and retrievable.* Perform other related duties as assigned**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.**Knowledge*** Experience in regulated environment and interaction with regulatory agencies* 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, project management 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.* Experience in compliance risk situations.**System/Computer Requirements:*** Basic Microsoft Office, MS Project, Adobe AcrobatTravel Percentage: 0%locations: Belfast, United Kingdomtime type: Full timeposted on: Posted Today