Job Description

Safeguard Medical, a global alliance of leading healthcare organisations, with category-leading devices and ground-breaking SIMBODIES simulations are looking for a strong team player, with a can-do and flexible attitude to join its Quality Assurance Department.

Job Summary

The QA Manager is responsible for execution of the Quality Assurance operations at one or more sites to ensure compliance with regulatory standards, company policies, and industry best practices. This role is critical in maintaining the effectiveness of the Quality Management System (QMS) in accordance with ISO 13485, FDA 21 CFR Part 820, and other applicable international regulations. The QA Manager will lead and manage the QA team and coordinate with cross-functional departments to uphold the quality of medical device products from development through post-market, and will promote and adhere to the company values of quality and compliance with current legislation.

Essential Job Functions

Manage the Quality department(s) and related personnel, including but not limited to providing leadership and development for the QA team, including performance management, training, and mentoring, delegation of work, and managing within an approved budget Work with leaders across the business to develop strategies and plans to fulfill the mission and goals of the business while maintaining compliance with quality standards and regulatory requirements Drive a culture of compliance through influence, relationships, and partnership with cross-functional leaders Act as the Person Responsible for Regulatory Compliance (PRRC) for SMT Act as an independent PRRC for Safeguard EU Rep for products from other Safeguard entities, as necessary Assist with the preparation of regulatory submissions including, but not limited to FDA submissions, CE Marking, UKCA Marking applications Management Representative - includes ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout SMT. Responsible for data collection, analysis, reporting and appropriately leading discussions for Quality Management Review meetings for applicable site(s) Manage and maintain the Quality Management System (QMS) in compliance with applicable regulatory requirements (e.g., FDA, ISO 13485, MDR) at one or more sites. Lead internal and external audits, including FDA inspections and Notified Body audits. Oversee CAPA (Corrective and Preventive Action) processes, nonconformance reports (NCRs), and root cause analyses, teaching others to perform root cause analysis of identified issues including identification of appropriate corrective and preventive action Ensure document control procedures are maintained, including the creation, revision, and obsolescence of quality documents. Review and approve quality-related documentation including procedures, protocols, validation reports, and batch records. Participate in risk management activities per ISO 14971 as necessary Support product development projects to ensure quality and regulatory requirements are met from concept through commercialization. Monitor quality metrics and KPIs to identify trends and areas for improvement. Ensure supplier quality management processes are effective, including audits, evaluations, and performance monitoring. Interface with regulatory bodies and represent the company during inspections and audits. Assist with preparation of data for PMS and PMCF Activities where necessary Final release of goods from production PMS and PMCF Approvals, as required

Qualifications

Education:

Bachelor's degree in Engineering, Life Sciences, or related field required.

Experience:

5+ years of experience in Quality Assurance in a regulated medical device environment. Preference for a minimum of 2 years in a managerial or leadership role. In-depth knowledge of FDA QSR, ISO 13485, ISO 14971, and other applicable regulations and standards. Full understanding of EU MDR 2017/745 and MDR 2002 Experience with audit readiness and hosting regulatory inspections. Previous experience as a Person Responsible for Regulatory Compliance (PRRC) preferred.

Skills:

Strong leadership and team management skills. Excellent written and verbal communication. Proficiency in quality management systems with a preference for experience in electronic document management systems (EDMS) Strong analytical and problem-solving skills. Detail-oriented with strong organizational skills. Effective QA Leader with demonstrated ability to work with cross-functional partners to drive a culture of compliance Technical knowledge and understanding of the medical device industry Computer literate & experienced in Microsoft Office applications Prefer training and experience as an ISO 13485 Internal Auditor Understanding of statistical analysis, root causes analysis, and the CAPA process Must fit within the Safeguard Medical culture

Employees of Safeguard Medical are entitled to the following Company funded benefits:

Competitive salary Private Medical Cover (with the option to select family cover at an additional cost) 3x basic salary life assurance cover Enhance employer pension contributions 24 days paid holiday
Job Types: Full-time, Permanent

Pay: 45,000.00-50,000.00 per year

Additional pay:

Performance bonus
Benefits:

Life insurance On-site parking Private medical insurance
Schedule:

Monday to Friday
Work Location: In person

Application deadline: 14/07/2025
Reference ID: 2509