Quality Systems Technician

OVERALL PURPOSE OF JOB

The Quality Systems Technician manages several critical quality systems processes within the Quality department and is also responsible for performing some other administration duties.

 

RESPONSIBILITIES

  • Overall administration, maintenance and improvement of the Quality Management System including:
    • Record keeping, retrieval and archiving and associated procedures.
    • Document control processes including periodic review, ensuring document changes occur in a time bound, controlled manner as per change notes, project plans or other requirements.
    • The Customer Complaint (CC) handling system and coordinating regular updates with internal and external teams to drive timely and effective closure.
    • Administration of Change Control processes including Change Board and monitoring conflicts with changes.
    • Administration of Quality Management Review (QMR) processes including data analysis/preparation and facilitating review meetings.
    • Administration of the internal and external audits schedule responsible for defining the schedule and monitoring for timely completeness.
  • Developing and executing training in Quality processes.
  • Generating regular reporting of status against the agreed KPIs.
  • For all tasks, make suggestions for continuous improvement of processes and implement where applicable / requested to do so.
  • Provide cover for other Quality roles during periods of absence.
  • At busy times reasonable requests may be made to perform duties of a similar nature.
  • Adhere to QMS, HSE policies and procedures and all other Mi3 policies and procedures at all times.
Additional Responsibilities
  • For all tasks, make suggestions for continuous improvement of processes and implement where applicable / requested to do so.
  • Provide cover for other Quality roles during periods of absence.
  • Interactions with suppliers, customers and Mi3 staff across all levels and departments.
  • At busy times reasonable requests may be made to perform duties of a similar nature.
  • Adhere to QMS, HSE policies and procedures and all other Mi3 policies and procedures at all times.
Qualifications & Experience
  • Degree educated with the required skills, knowledge and abilities that are typically acquired through a minimum of 3 years’ experience in the medical device industry.
  • Proficient in the knowledge of applicable standards, regulations and requirements e.g., GMP, GDP, MDR, MDSAP, ISO 13485 and ISO 14971.
  • Advanced knowledge of medical device Quality Systems, Manufacturing, Failure Investigation/Problem Solving, RCA and CAPA.
  • Advanced level skills with Microsoft Office (Outlook, Word, Excel etc.).
  • Ability to work effectively and independently with minimal guidance in a fast-paced environment.
  • Time management skills including multi-tasking completing priorities as needed.
  • Having a positive attitude, a desire to learn and be challenged.
  • Demonstrated self-motivation and ethical behaviour.
  • Must be an effective team player with the ability to mentor, lead and problem solve to provide solutions to the business.
  • Confident and open personality who can communicate effectively, both written and orally with people at all levels.
  • Internal and/or external auditing experience or qualification, to ISO 13485 preferred.
Apply Now

To apply for this position, please email your CV and covering letter to jobs@mi-3.co.uk