Quality Systems Manager/QMS Specialist

TN United Kingdom; Farnborough; Hybrid; GBP 40,000 - 80,000; Full time

Job summary

An innovative firm is seeking a Quality Systems Manager/QMS Specialist to oversee Quality Management Systems and ensure compliance with FDA and ISO13485 standards. This role involves harmonizing quality systems across the business, planning audits, and collaborating with cross-functional teams to drive quality initiatives. The position offers hybrid working arrangements to support work-life balance, competitive salary, and performance bonuses. If you're passionate about quality in the medical device industry and thrive in a dynamic environment, this is an exciting opportunity to make a significant impact.

Benefits

Yearly performance bonus

Flexible working arrangements

Support for work-life balance

Qualifications

• Experience in the medical device industry with knowledge of ISO13485 and FDA standards.
• Ability to work with cross-functional teams and communicate effectively.

Responsibilities

• Manage compliance with FDA regulations and ensure guidelines are consistent.
• Plan and schedule audits to meet internal policies and external regulations.

Skills

Quality Management Systems

ISO13485

FDA QSR standards

Root cause analysis

Corrective and preventive actions

Organizational skills

Analytical skills

Communication skills

Education

Bachelor’s degree in a scientific or technical field

Job description

Quality Systems Manager/QMS Specialist, Farnborough

Client: Philips

Location: Farnborough, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference: 677543857a8c

Job Views: 14

Posted: 05.05.2025

Expiry Date: 19.06.2025

Job Description:

Role: Manage the site Quality Management Systems, CAPA, Audits, and certificates, providing recommendations to management, PMS, Engineering, and production teams.

Responsibilities:

1. Own quality systems and harmonize them across the business; establish an effective Management Review process, including routine reporting.
2. Manage compliance with FDA regulations and other regulatory agencies, ensuring guidelines and policies are consistent with those regulations for all products and operations.
3. Plan and schedule audits to meet internal policies and external regulations.
4. Interact with all involved in product development, customer service, sales, and marketing, providing training, direction, and consultation.
5. Offer hybrid working from our offices in Farnborough, Hampshire, with flexibility to support work-life balance.
6. Enjoy a competitive salary, yearly performance bonus, and other benefits—discuss these with your recruiter.

Candidate Requirements:

1. Bachelor’s degree in a scientific or technical field.
2. Experience in the medical device industry with knowledge of ISO13485, EU MDD, and FDA QSR standards.
3. Focus on Quality Management Systems and audits.
4. Experience with corrective and preventive actions, root cause analysis, and implementing solutions.
5. Ability to work with cross-functional teams and communicate effectively with senior stakeholders.
6. Strong organizational and analytical skills, with the ability to troubleshoot complex issues and manage multiple priorities.

If you meet some of these criteria and are interested, we encourage you to apply. Philips values diversity and inclusion, and we support reasonable adjustments during the recruitment process.