QA Manager

  • Location:

    Wirral, Merseyside

  • Sector:


  • Job type:


  • Salary:


  • Contact:

    Alannah Fisher

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  • Published:

    10 months ago

  • Expiry date:


  • Startdate:


Quality Assurance Manager
Competitive salary

My client a leading diagnostics company are looking for a QA Manager to join their small team and manage the daily quality assurance activities within the company.
This vital position will work with all departments within the company including, manufacturing, R&D, QC, and Sales & Marketing to ensure compliance with our quality management systems. They will perform and maintain critical quality systems (e.g., ISO13485, FDA Quality System Regulation, non-conformances, corrective and preventative actions, investigations, training, and metrics) as they relate to product development, manufacture, and auditing of internal and external quality assurance related activities.

Job responsibilities of the QA Manager:

* Assure the design control and manufacturing of the products are in compliance with required regulations, for example FDA Quality System 21 CRF, Part 820) and ISO13485:2016 Regulations.
* Manage the maintenance and integration activities related to the Quality Systems, providing assistance with internal team members, customer and regulatory audits, and identifying opportunities for and implementation of continuous improvement. Responsible for continuous improvement of core quality systems to ensure optimization without compromising regulatory compliance.
* Provide hands-on ownership for the various elements of the quality system to ensure successful performance during third-party audits and regulatory inspections.
* Assist all departments with the application, maintenance and improvement of quality systems and department specific procedures.
* Lead root cause analysis and develop associated CAPA to prevent recurrence and ensure completion of effectiveness checks.
* Lead the program for developing and justifying meaningful quality system metrics and provide regular updates to Quality management.
* Initiate updates and creation of new functional SOPs as required.
* Serve as Quality representative for Quality System audits and regulatory inspections as needed.
* Comply with all safety and quality standards.
* Manage regulatory compliance issues and communication with regulatory bodies.
* Manage Internal and External Audits, including regulatory bodies and customers
* Manage supplier approval process

The successful candidate for the QA Manager post will have:

* A BSc or equivalent in Life Sciences.
* Previous industrial working experience under ISO13485 or FDA QSR.
* Excellent working knowledge and understanding of GMP-related requirements and proficiency of regulatory guidelines with the ability to assess risk.
* Experience in establishing and implementing ISO13485 or FDA QSR quality system
* Experience in administering quality management systems such as US FDA QSR (21 CFR: 820) ISO 13485:2016
* Familiarity with IVD product development process such as design control and IVD product manufacturing.
* Excellent working knowledge and understanding of GMP-related requirements and proficiency of regulatory guidelines with the ability to assess risk.

If you have previous experience working as a QA Specialist or QA Manager to ISO13485 standards and you're looking for a new challenge then please apply now!

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