Job Description
Job Title: Quality Audit Manager, QMS Training
Job type: Permanent
Location: Oxford, UK (hybrid)
A world-leading medical technology company developing innovative solutions are seeking a motivated Manager, Auditing and QMS Trainer to join the team as part of its global expansion. This is an opportunity to work in an innovative, fast-paced global medical device organisation committed to improving patient outcomes.
The Manager, Auditing & QMS Trainer will oversee the evaluation of the company's QMS and provide leadership in the development and delivery of QMS training materials to all employees. This role is critical in upholding the company’s values of innovation, evidence, integrity, teamwork, respect, and commitment to transplantation.
The role plays a key part in developing and maintaining oversight practices for the QMS, including internal audits and scheduling. Additionally, the role is responsible for creating and distributing QMS training materials and ensuring their delivery to all employees globally. The Manager will also coordinate external regulator and notified body audits, defining best practices, communication tools, and records to ensure an effective and efficient audit process.
Responsibilities:
* Leadership and oversight on Audit functions
* Defining, improving, and executing our Internal and External Auditing practices
* Direct Internal Audits
* Define and implement best-in-class external auditing practices and systems
* Define and implement an effective QMS Training process for all employees
* Develop training material content and delivery methods
* Offers proficient level guidance and direction of the Auditing and Training Bodies of Knowledge
* Proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc., with focus on auditing and training
* Creates an inclusive learning environment with the Auditing and Training Team that is aligned to the organisation’s Values, Mission and business objectives
* Represent the Auditing and Training Function in Management Review and provide periodic reporting on the completion and status of audits and training activities.
* Provide leadership and define organizational activities in support of the QMS oversight and content delivery
* Maintain evidence-based Quality Metrics and define and execute activities to meet these metrics.
Requirements :
* BSc in Bioscience, engineering or equivalent or other related field
* 4+ years’ experience within quality in the medical device industry, specifically QMS, auditing and training content development and delivery
* Experience working with Class II or III devices
* Domestic and International regulatory requirements,
* Ability and willingness to travel
* Strong project management skills
* Six Sigma qualification is highly desirable
For further information, please reach out to or call 020 3376 5104