Quality Assurance Compliance Specialist

Opera is a family-owned business passionate about enhancing lives, built on values of care, support, passion and professionalism. Established in 2004, Opera has become a market leader in designing and producing care beds, pressure care mattress systems for the long-term care market. We are an expanding business and keen to grow our team with people who naturally reflect and live our values.

We are looking for an experienced Quality Assurance Compliance Specialist to join the team to ensure that documents meet the organisation’s needs and meet regulatory requirements solutions for market-leading care beds and medical devices.

The role will support the creation of regulatory submissions, PMS and Technical Files and/or updating documents, and actively participate in the creation, implementation, and continuous improvement of the quality management system, including developing and maintaining quality systems and processes.

The role will also supply additional QC and H&S support to the operations department where required. It will involve tasks to support the continuous improvement of internal quality processes, general H&S activities.

At Opera Beds, you will find a company of people who care about each other, about their customers and their users, and about the communities where we live and work.

Key Responsibilities

  • Ensure that quality system requirements are effectively established and maintained in accordance with all applicable medical device regulations, including ISO 13485, ISO 9001 and other standards.
  • Maintain regulatory compliance for Opera-manufactured products, including registrations, listings, amendments, submissions, letters to file, labelling, UDI, and other requirements.
  • Create and maintain regular lines of communication across the business to promote quality awareness, regulatory partnership, and harmonization of quality processes.
  • Conduct internal audits and provide guidance regarding best practices and continuous improvement.
  • Promote audit readiness, prepare quality teams for audits by external bodies, including MHRA, BSI, and facilitate audits as needed.
  • Support monitoring, measurement, and effectiveness of the quality systems to continuously improve performance.
  • Partner with teams on the execution of corrective action plans, tracking and verifying that deficiencies are corrected.
  • Maintain current knowledge of MHRA, legislation, best practices, and guidelines related to QA/RA and any changes to applicable laws and regulations
  • Provide consultative guidance to product leadership, quality and other stakeholders of QA/RA issues.
  • Supporting the operations department with QC and H&S support

Key Requirements:

  • Experience – minimum of 2-3 years with Medical Device or similar work experience
  • Experience in Quality Control management
  • Awareness and experience of ISO 13485 Quality System Requirements, Medical Device Directive, ISO 14971 Risk Management for Medical Devices and BS 7177 requirements
  • Understand basic QA/RA principles
  • Understand and comply with all quality procedures
  • Strong communication skills, both verbal and written
  • High level of attention to detail

Benefits:

  • Competitive Salary
  • Company Pension Scheme
  • Free Lunch – 3 days per week.
  • 28 Days holiday (Including bank holidays)
  • Free on-site parking
  • The role will be based at the Opera head offices in Hull, HU7 3AP with working hours 8:00 am-4:30 pm

The role is a standalone role with no direct reports, allowing flexibility on hours and some work from home.

If you have the skills and can demonstrate similar values we’d love to hear from you by emailing recruitment@operabeds.com