Quality Systems Manager

🔒 Confidential Employer

Posted 23 April 2026

LOCATION

Deeside

TYPE

Full-time

LEVEL

Mid-Senior level

SKILLS

Quality Systems ISO13485 21 CFR 820 CAPA Root Cause Analysis Medical Devices Audit QMS

FULL DESCRIPTION

This function is responsible for the management and oversees of the Quality Systems. Responsible for developing, identifying, analyzing, and improving the quality system. This process will follow the [Employer hidden — view at passion-project.co.uk] Quality Management Systems, as well as applicable regulations and standards (e.g. 21 CFR Part 820, ISO13485, Japan MO-169, Brazil ANVISA) The position requires empowerment and proactivity, time management skills, organization, and attention to detail. The role will have interaction and/or communication, when applicable, with employees, customers, suppliers, third parties.

Key Responsibilities:

Supervise the Quality systems team and their support to both Wound Care plants.
Assist and Coach the teams in conducting investigations of Trainings, Document activities, complaints, nonconformities and /or corrective preventive actions.
Oversee the Complaint system, assuring corresponding evaluations and/or investigations are completed in a timely manner, trends are analyzed, and applicable actions are executed (e.g. CAPAs, SS, HHE)
Report progress of investigations for complaints, non-conformities, preventive/corrective actions, internal/external audits, stop shipments, HHEs, supplier quality and any other applicable Quality System requirement.
Oversea the CAPA system, assuring corresponding investigations, corrections, containment, and corrective/preventive actions are taken, as well as insuring that their effectiveness is measured; this while also maintaining a system that complies with QMS requirements.
Oversea the Training and Document Management system, assuring corresponding activities, trainings, evaluations and/or investigations are completed in a timely manner, trends are analyzed, and applicable actions are executed.
Execute/report/Analyze trend analysis related to the quality management system.
Participate in local and/or corporate meetings representing the site Quality System and communicating any action/activities that are needed.
Oversee/prepare corresponding reports and/or meeting (e.g. trend analysis, management reviews) to assure the Quality System is robust and complies with requirements, and, if applicable raise corresponding action to keep in compliance.
Manage the Quality Audit Process. Oversee/prepare the schedule and coordination of both internal audits and external audits. Conduct audits and support auditors. Conduct audits according to the program and communicate their results. Report non-conformities found during audits. Prepare and submit audit reports.
Lead external audits and certification program.
Support and participate in company projects.
Identify, develop, and implement continuous improvement projects for products and processes.
Carry out, together with your team and if required, CAPA (Corrective and Preventive Actions).
Follow and enforce the corresponding policies and procedures, implementing solutions aligned to the needs of the business and its products.

Skills & Experience:

5+ years of experience in medical devices industry in leading positions.
1 year experience in management/principal positions (preferred).
Experience in leading front or back rooms during external regulatory body Audits.
Experience leading external audits in sister plants (preferable).
Experience with submitting Local Registrations (preferable).
Experience leading investigations of Audit finding (preferable).
Experience in execution training programs (preferable).
Experience with QMS regulated software.
Knowledge of change control principles, quality systems, training, standards, and regulations of Medical Device Quality systems.
Demonstrated proficiency in complaints, non-conformance and CAPA management.
Skill on root cause, continuous improvement, and statistical tools.
Strong motivation to achieve good results is essential. Self-directed leadership, requiring minimal supervision and proactive attitude.

Qualifications/Education:

Bachelor’s degree in industrial engineer, business administration (desirable) or any other related grade.
Knowledge of the Quality Assurance standard for medical devices like ISO13485 and 21 CFR 820.
Knowledge of root cause analysis tools.

Team:

Quality Systems Leads and applicable personnel

Travel Requirements:

You will be expected to travel an estimated 5% -10% of the time, mainly to different [Employer hidden] plants (depending on business requirements).

Working Conditions:

Hybrid working model - 3 days per week on site at our Deeside, Wales location
12 month fixed-term contract

Special Factors:

EH&S requirements are established in local procedures.
Employee will not be exposed to any chemicals
Maintain general awareness of the CVT’s EHS policy and supporting standards.
Understand EHS risks and applicable legal requirements associated with their job responsibilities and the appropriate controls in place to manage those risks and requirements.
Carry out job responsibilities with due professional care and in compliance with legal requirements and internal standards without compromising their own safety or that of others.
Be alert to EHS hazards in the workplace, responding to them as appropriate and communicating them to responsible management as they are identified (e.g., spills).
Participate in training, awareness, and community initiatives as appropriate.
Help drive continuous EHS performance improvement by suggesting potential improvements to responsible management.