Medical Device Lead Auditor

4 weeks ago

United Kingdom SGS Full time

Company Description

We are delighted that you're thinking about a career with SGS

We currently have an exciting opportunity at SGS for a Medical Device Auditor to join our highly successful certification division.

SGS are the global leader and innovator in inspection, verification, testing and certification services. Trusted all over the world, SGS is a market leader because we put 100% passion, pride and innovation into everything we do. We encourage new ideas. We welcome people who challenge the way we do things. And we will be 100% committed to helping you reach your full potential.

Job Description
  • Job Title: Medical Device Lead Auditor
  • Job Type: Permanent
  • Hours: 37.5 hours per week
  • Job Location: Field-based (UK, South Region)
  • Travel: Within the UK, a Company car or car allowance provided
  • Salary: From £64,000
At SGS, we believe in rewarding our employees for their hard work and commitment. As part of our team, you would be eligible for:
  • Retention bonus scheme (Bonus rises each year of employment)
  • Private medical cover (subject to eligibility criteria)
  • Competitive pension scheme + Life Assurance
  • Generous Annual Leave allowance (increasing with service) plus bank holidays.
  • An additional day off for your birthday
  • Discounted Gym Membership
  • Retailer Discounts
  • Access to electric vehicle leasing scheme (subject to eligibility criteria)
  • Enhanced maternity/paternity and adoption pay.
  • Length of Service Awards
  • Christmas Vouchers
  • Health & Wellbeing initiatives
We have an excellent opportunity for a Medical Device Lead Auditor to join our global organisation.

The successful candidate will be responsible for planning and conducting audits of medical devices to EU MDD 93/42/EEC, EU MDR 2017/745, Directive 93/43/EEC equivalent to UK MDR 2002 as amended for UKCA, ISO 13485 and MDSAP, enabling the delivery of assessment and certification services that meet customer and regulatory requirements by appropriate accreditation requirements.

Key Accountabilities:
  • Conduct audits at clients' sites and remotely, by established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
  • Work alone or lead audit teams as appropriate, enhance client satisfaction and ,ensure compliance with standards and regulatory requirements.
  • Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.
  • Complete specific projects about medical device procedures, processes, systems and documentation as requested by the Medical Devices Manager.
Qualifications

A minimum of 4 years of professional experience in relevant field of healthcare products or related activities;
  • Work in medical devices industry or closely related industries (e.g. pharmaceutical industry) such as research and development, manufacturing, quality management, regulatory affairs
  • Work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies
  • Work in the application of device technology and its use in health care services and with patients
  • Testing devices for compliance with the relevant national or international standards
  • conducting performance testing, evaluation studies or clinical trials of devices
  • 2 years of the 4 of relevant professional experience shall be in quality management. E.g. Quality Manager/Engineer, CAPA or complaint Manager/Engineer.
  • Work experience in positions with significant QA, Regulatory or management systems responsibility
  • Experience with UKCA and SSD guidance, Standards and regulations for non active devices
  • Experience with Risk Management EN ISO 14971
In addition:
  • Experience of working under own initiative and in planning and prioritising workloads.
  • Full driving license use in the UK.
  • Good English written and verbal skills.
Additional Information

APPLY NOW for full consideration, you can be sure that your application will be treated confidentially and impartially, and you will always receive an update within 10 business days.

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