Quality Project Manager
Primerdesign, part of the Novacyt Group, is a leading provider of RT PCR solutions. We have thousands of happy customers based across the globe and have a real ambition to drive our business forward and achieve even more.
We are currently looking for a Quality Project Manager to join our team in Camberley and take on a temp-to-perm contract for an initial one year period.
- Excellent salary
- 25 days’ annual leave
- Ability to buy and sell annual leave
- Cycle to work scheme
- Refer a friend scheme
- Life assurance
- Private medical insurance
- Group pension scheme
If you are an experienced quality professional with knowledge of ISO 9001, ISO 13485, 21 CFR Part 820 and IVD Directives, this is an exciting opportunity to play a key role in the ongoing success of our leading business.
Operating at the forefront of the medical device sector, we are an innovator in every sense of the word. From the products that we make to the people we employ, innovation runs through the heart of our business.
We’ve been making huge advancements in the fight against the COVID-19 pandemic as well as a wide range of other medical areas and we even won the breakthrough of the year award at the European Mediscience Awards 2020. As such, it’s an exciting time to join us as we grow and continue to flourish.
So, if you want to take on a new challenge with a pioneering, technical business and ensure that quality and compliance standards are maintained to an exceptional level, this is the role for you.
As the Quality Project Manager, you will be tasked with overseeing quality remediation projects for our QMS at our site in Camberley.
Working alongside the Quality Manager, you will manage the transition of the existing QMS to meet revised standards and new IVD regulations. You will also ensure that production operations continue to meet high standards and our certification is maintained.
Additionally, your role will involve:
- Driving multi-functional teams to meet project goals
- Deputise for the QA/RA Director as required
- Maintain quality policies for our Group
- Work with the Quality Manager, the QC Team and the Production Team to document manufacturing processes
- Support internal audits and third party audits
- Develop and report on relevant KPIs for the Camberley site
- Support the management of the QA/QC Teams
To be considered as a Quality Project Manager, you will need:
- At least five years’ previous experience of managing quality management systems in accordance with ISO 9001, 13485, 21CFR part 820 and IVD Directives (98/79/EC)
- A proven track record of project management and, ideally a PRINCE2, AgilePM or Change Management certification or qualification
- To be a strong team leader with evidence of successfully managing and developing teams
- Previous experience of hosting audits with competent authorities and/or notified bodies
- Knowledge of upcoming IVD regulations
- Knowledge of CE mark technical documentation, GHTF STED and IVD CTS documentation requirements
- Knowledge of root cause analysis techniques, FMEA and risk analysis techniques
- Knowledge of desgn control, risk management and product development processes and batch release
- An internal auditor training and certification to ISO 9001 and/or ISO 13485
A degree or HNC in a relevant scientific or engineering discipline would be beneficial to your application.
Other companies may call this role Quality Assurance Manager, Regulatory Assurance Manager, QA Manager, or Regulatory Compliance Manager.
We would be eager to hear from you if you have experience as a Quality Manager, Internal Auditor, Certified Internal Auditor, or Compliance Manager.
Webrecruit and Primerdesign are equal opportunities employers, value diversity and are strongly committed to providing equal employment opportunities for all employees and all applicants for employment. Equal opportunities are the only acceptable way to conduct business and we believe that the more inclusive our environments are, the better our work will be.
So, if you are seeking your next step as a Quality Project Manager, please apply via the button shown. This vacancy is being advertised by Webrecruit. The services advertised by Webrecruit are those of an Employment Agency.