Quality Systems Manager

ZipRecruiter; Bedford; On-site; GBP 50,000 - 70,000; Full time

Job summary

A medical device company in the UK is seeking a Quality Systems Manager to lead the administration and improvement of their Quality Management System. The ideal candidate should have hands-on experience in the medical device industry and a technical background. Responsibilities include managing electronic quality processes, ensuring compliance with regulatory standards, and collaborating across teams to enhance quality outcomes. This role provides an opportunity to impact patient lives positively and contribute to a growing organization.

Qualifications

• 3+ years of hands-on experience with electronic Quality Management System (eQMS) in the medical device industry.
• Proven ability to manage QMS reporting metrics.
• Experience with regulatory audits (ISO 13485, JISO 9001, MDSAP, FDA).

Responsibilities

• Lead development and management of the Electronic Quality Management System (eQMS).
• Identify opportunities to improve QMS workflows.
• Conduct audits and prepare for regulatory compliance.

Skills

Quality Management System (QMS)

Data-driven decision making

Regulatory compliance

Cross-functional collaboration

Problem-solving methodologies

Education

Bachelor's degree in a technical field

Tools

Arena

Job description

Job DescriptionJob Description

Lexington Medical is a medical device company, developing and manufacturing minimally invasive surgical stapling solutions in the Boston area. With the highest standards in design engineering and smart manufacturing, our team delivers disruptive technology to health care providers which improves surgical outcomes for their patients in a thriving $6B+ Surgical Stapler market.

Rooted in a talent dense culture, we are committed to innovation, foster continuous growth and achieve great heights, together. At Lexington Medical, you will have the opportunity to impact the lives of millions of patients worldwide and thrive in a growing company.

As the Quality Systems Manager at Lexington Medical, you will lead the administration, maintenance, and continuous improvement of our Quality Management System (QMS), ensuring alignment with all applicable quality and regulatory requirements.

Our ideal candidate thrives in a fast-paced, entrepreneurial environment, takes initiative, and brings a hands-on, results-driven approach to quality leadership. You should be a collaborative team player who excels at managing and enhancing QMS processes while ensuring ongoing compliance. If you're passionate about quality, enjoy wearing multiple hats, and want to make an immediate impact at a rapidly growing medical device company, this role could be the perfect fit for you.

Responsibilities:

• Lead the development, implementation, and upkeep of the Electronic Quality Management System (eQMS), ensuring compliance with ISO 13485, FDA 21 CFR Part 820 (QMSR), MDSAP, and other applicable regulations.
• Identify opportunities and lead initiatives to improve QMS workflows, including change control, training, CAPA, nonconformance, audits, design control, risk management, production/process controls, and supplier management.
• Manage the full lifecycle of the QMS to support continuous compliance and system effectiveness.
• Create and execute data analysis plans to track and trend key performance indicators (KPIs) and support data-driven decision making.
• Maintain and manage standard operating procedures (SOPs) and related documentation to meet global regulatory requirements.
• Collaborate with cross-functional teams—operations, quality, engineering, regulatory, and manufacturing—to ensure consistent product quality.
• Conduct or support eQMS system validation activities, as needed.
• Support audit readiness and participate in internal and external audits.
• Perform other QMS-related duties as assigned.

Qualifications:

• Bachelor's degree in a technical field; quality-related certifications (e.g., CQA, CQE) are a plus.
• 3+ years of hands-on experience implementing and maintaining an electronic Quality Management System (eQMS) in the medical device industry; experience with Arena is strongly .
• Proven ability to develop and manage QMS reporting metrics that support data-driven decisions across the organization.
• Strong team player with experience leading QMS activities in a cross-functional setting.
• Ability to apply risk-based thinking to quality processes and decision-making.
• Experience preparing for and supporting external regulatory audits (e.g., ISO 13485, ISO 9001, MDSAP, FDA).
• In-depth knowledge of international quality regulations and standards, with practical experience in ISO 13485, MDSAP, and/or FDA 21 CFR Part 820.
• Strong communication and interpersonal skills with the ability to influence, collaborate, and drive quality initiatives across departments.
• Skilled in applying structured problem-solving methodologies with a practical, results-oriented mindset.