Senior Quality Systems Engineer
OLYMPUS CORPORATION
Cardiff
12d ago

Your responsibilities

  • Motivate and monitor performance of sub team to ensure departmental objectives are achieved in compliance with established quality procedures.
  • Implement and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of : Corrective and Preventive Action (CAPA), Complaint, Post Market Surveillance and Non-
  • conformance Report (NCR).

  • Review and provide information to National Competent Authorities on behalf of Olympus business centres to ensure their compliance with the Medical Devices Vigilance system.
  • Participate in the interpretation of Regulatory Requirements (ISO13485 : 2003, Medical Device Directive MDD 93 / 42 / EEC and 21 CFR Part 820) to produce effective working policies and procedures.
  • Provision of advice according to established procedures relating to CAPA, Complaint, Post Market Surveillance and NCR and against the external requirements of the relevant regulatory authority and local quality standards.
  • Interpretation of RA requirements to provide technical and system advice / guidance as necessary to ensure compliance to standards.
  • Provide effective solutions / advice to design and manufacturing teams on established procedures to ensure products are designed and developed and manufactured according to the requirements of the relevant regulations
  • Analyse data, including the use of statistical techniques, to provide reports to management to enable them to monitor system performance.
  • Review and authorise documentation and processes in the Quality Management System to ensure compliance with established quality procedures and applicable regulations and alignment with other related documentation.
  • Identify and collaborate in the implementation of changes to the Quality System to increase efficiency and / or effectivity whilst ensuring compliance with applicable regulations.
  • Support and perform training throughout the company to maintain awareness of the Quality System requirements.
  • Support and conduct internal and inter-company Quality System Audits in line with local and group objectives.
  • All other duties as required.
  • Deputise for QS Manager when required, to ensure progression of departmental commitments.

    Supervisory responsibility for QS Engineers

    Your qualification

    Education / Qualifications

  • Diploma level Science / Engineering / Quality orientated qualification
  • Behaviours / Skills / Experience

  • Minimum of 3 years experience working in a QA / QS environment within the medical device or pharmaceutical industry.
  • Knowledge of ISO13485 : 2003, Medical Device Directive MDD 93 / 42 / EEC and FDA QSR Part 820
  • Good analytical skills and experience of statistical techniques
  • Computer literate to include MS Word and Excel and MRP
  • GMP and audit qualifications
  • Supervisory experience.
  • Ability to work with minimal supervision and use initiative.
  • Good inter-personal skills and the ability to communicate well in English both written and orally.
  • Good record / documentation skills.
  • Works with integrity, customer focus, accountability and teamwork.
  • Standard competencies :

  • Consistently hold people to account by making expectations explicit and regularly reviewing performance
  • Motivate others through leading by example and creating an expectation that our colleagues do the same
  • Provide both timely positive and negative feedback
  • Understand our customers needs and deliver on our agreed commitments managing both risk and value to provide an optimum solution
  • Communicate clear goals, objectives, consequences and timeframes for everyone
  • Develop right first time approach to everything
  • Foster respect, openness, collaboration and trust
  • Empower and equip our people to take responsibility
  • Your benefits

  • Generous Pension Scheme
  • Private Medical Insurance
  • Employee Assistance Programme
  • 25 days Annual Leave
  • Flexitime
  • Employee discounts
  • About Olympus Medical Systems

    The Medical Systems Division represents Olympus’ largest business domain and is the global market and technology leader for medical endoscopes.

    Olympus aims to continuously find better and more economical solutions to medical issues which improve the well-being of patients, enhance the working environment for doctors and nursing staff and help to develop the overall performance of health care providers.

    More reasons to join our team

    Further information :

    Quality SystemsAll applications must be received by the closing date of 06 July 2018 and will not be accepted after this deadline.

    Should the volume of applicants be sufficient we reserve the right to close the application process earlier than the stipulated deadline.

    Note for Recruitment Agencies :

    At Olympus Surgical Technologies, we have a dedicated in-house recruitment team that cover all areas of the business. As a backup, we have a preferred supplier list (PSL) of vetted suppliers and as such, are unable to accept unsolicited CVs from recruitment agencies or search firms outside of our PSL (which is now closed to new suppliers).

    Please note that Olympus Surgical Technologies Europe will not be responsible for any fees, charges or terms associated with any such CVs.

    CVs will only be accepted from approved agencies where terms and conditions have been agreed and we have instructed them to work on specific positions.

    Agencies will be contacted by the recruitment team should we wish to engage their services. We do not take sales calls and politely request that you refrain from directly approaching the recruitment team or line managers and remove Olympus Surgical Technologies Europe from your mailing list.

    Thank you for your understanding.

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