Quality Director Medical Devices jobs

Quality Manager

Reports to: Head of Quality & Responsible Person (RP)

Location: Kettering with occasional travel to other sites (London, Reading and Manchester)

Package: Competitive salary + annual bonus

About The Role:

The Quality Manager & RP supports the Responsible Person in maintaining compliance with Good Distribution Practice (GDP) guidelines to ensure the Quality, safety and integrity of products throughout the Healthxchange supply chain.

Reporting to the Head of Quality, the Quality Manager & RP will collaborate closely with cross-functional teams to identify areas for improvement and support the implementation of best practices to uphold our commitment to Quality. This role will also include the added responsibility of acting as the Responsible Person (RP).

About Healthxchange:

Founded in 2000, Healthxchange is the leading supplier of medical aesthetic products and services to professionals across the UK & Ireland. Healthxchange proudly partner with award-winning brands including Obagi Medical, Medik8 and Jane Iredale to strategically commercialise their products in market. We currently supply over 9,000 clinics with a full range of products (Skincare, Injectables, Energy-based devices) and services (software & education) to support their 360 business needs. The company offers a dynamic environment for innovation and growth in the medical aesthetic space.

Responsibilities:

• Support the implementation & maintenance of Healthxchange’s commitment towards GDP, GMP and GPhC Regulatory standards

• Provide daily support towards Healthxchange’s operations licences at all sites; namely WDA(H) & MS licenses

• Assist the Head of Quality in implementing and maintaining applicable standards across all Healthxchange operations

• Act as the Responsible Person

• Oversight and maintenance of the Quality Management System (QMS) including document control, change management, deviation and CAPA management, complaint management and validation activities.

• Assist in the development and improvement of procedures, protocols and departmental documentation

• Support customer, supplier qualification and re-qualification

• Outsourced activities qualification

• Partake and support internal and external audits to assess compliance whilst continually removing risk from Healthxchange operations

• Perform quality risk assessments

• Perform investigation of temperature excursions and impact assessments

• Management of the product recall

• Provide guidance and support to cross-functional internal teams on QA related topics

• Drive continuous improvement initiatives to enhance QA systems, processes & performance

• Maintain and support GDP/GMP training to internal colleagues to ensure staff are consistently aligned with applicable industry regulations and expectations

• Collaborate with the Head of Quality to manage and report QA KPIs that assess Quality effectiveness across Healthxchange, including trend analysis and identification of improvement opportunities

• Collate information and host Quality Management Review meetings

• Ensure timely resolution of QA related issues and deviations to minimize risk to customers, patients and Healthxchange supply chain of products

• Support the Head of Quality in communications with external agencies and clients in all matters pertaining to QA/Regulatory

• Other duties which may be reasonably required from time to time, including delegated duties during the absence of colleagues.

Requirements:

• Batchelors degree in related field (Quality Assurance, life sciences etc)

• Minimum of 3 years’ experience in a QA role in pharma industry (GDP, GMP, GxP)

• Experience in GxP QMS management

• Previous RP experience on WDA(H) (preferably with the same licence conditions)

• Strong analytical, problem-solving and decision-making skills

• Effective communication and interpersonal skills

• Excellent attention to detail with strong analytical skills

• Ability to work independently and collaboratively across multiple cross-functional departments

• Preferred knowledge of Lean Six Sigma principles and methodologies

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint)

Benefits

Company pension, annual performance bonus, 25 days holiday plus bank holidays (and increasing with service), staff discount, staff social events, access to Health Assured EAP.

Healthxchange is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer, and we welcome and encourage applications from all qualified individuals regardless of race, colour, religion, sex, sexual orientation, gender identity, national origin, age, disability status, marital status, or any other legally protected status. All employment decisions are based on merit, qualifications, and business needs.