Quality Manager - Medical Devices

Posted 9 November by Exectec

Quality Manager - Medical Devices

Essex / Hertfordshire Border

Salary Guide: £50,000 - £60,000 pa

A Quality Manager with detailed knowledge of medical devices is required by a leading manufacturer that develops chemical technology for the treatment of breathable gases.

The Quality Manager will support, as part of the senior leadership team, the development of optimal quality and regulatory performance and efficiency thus facilitating the delivery of the company's goals of achieving excellence in Safety, Quality, Delivery and Cost. The role will lead the quality function and will be a focal point in maintaining the compliance and effectiveness of the Business Quality Management System (BQMS) of the company.

Whilst being fully abreast with the applicable regulatory requirements and standards for the product, process and/or service developed, manufactured and provided, it is essential for this role in driving continuous improvement whilst promoting/maintaining compliance culture throughout the organisation.

Responsibilities& Authorities:

  • Planning the quality, regulatory strategies of the company
  • Provide leadership to QA/QC/Regulatory team
  • Main responsible in managing and maintaining compliance with the applicable medical device regulations e.g. MDD 93/42/EEC (migration to MDR), US FDA 21 820 QSR, CFDA No. 650
  • Main responsibility in managing and maintaining conformance with ISO 9001 and ISO 13485 certifications
  • Act as the main contact person in liaison with the national competent authorities and notified body
  • Managing the application and/or renewal of product registration and license
  • Hosting management review meetings and report to senior management the overall performance of the Business Quality Management System (BQMS) and HS&E issues
  • Hosting of client/3rd party audits, and managing any non-conformance's to satisfactory outcome
  • Management and submission of technical files for manufactured medical products
  • Evaluation and reporting to competent authority any adverse incident arising from customer complaints
  • Providing quality/regulatory input in the NPD/EPD process
  • Managing the internal audit program and provide support to pool of auditors
  • Leading/assisting the investigation of quality issues, customer complaints or product failure
  • Carry out periodic review of procedures to ensure effectiveness of the processes is maintained
  • Reviewing and approval of product labelling and marketing materials to ensure compliance with the applicable regulatory requirements
  • Provide full regulatory support to export markets as required
  • Ensuring all processes needed for BQMS are documented and controlled
  • Reporting to top management on the effectiveness of the QMS and any needed improvements
  • Promoting awareness of applicable regulatory requirements and BQMS requirements throughout the organization.

Knowledge & Experience:

  • Knowledge of Medical Device Regulations (EU/Global) is essential
  • Knowledge of international/harmonised standards, such as, ISO13485, ISO9001, ISO 14971, ISO14001 HSE 18000
  • Significant Experience in:
    • QA Management position in a manufacturing based SME environment within a regulated industry (medical device / drug or other suitable industries)
    • generating comprehensive and effective reports
    • Experience in process control improvement projects
    • Experience in QMS and supplier audits/development
  • Knowledge of international/harmonised standards, such as, ISO13485, ISO9001, ISO 14971, ISO14001 HSE 18000
  • Relevant degree in management/manufacturing/law or equivalent (desirable)

Salary Guide: £50,000 - £60,000 pa

Location: Harlow, Essex

Please bear in mind that you may not hear from us straight away. Due to the high level of applications we receive every day, we can only respond to applicants whose skills and qualifications are suitable for this position.

Required skills

  • MDR
  • ISO 13485
  • medical devices
  • MDD
  • ISO13485
  • qulaity manager

Application questions

Do you have regulatory knowledge?
Do you have knowledge of Medical Device Regulations EU/Global ?
Can you commute to Harlow in Essex?
Have you managed a team within a qulaity department?

Reference: 39330754

Bank or payment details should never be provided when applying for a job. For information on how to stay safe in your job search, visit SAFERjobs.

Report this job