Quality Assurance Manager
Job Description: Quality Assurance
Title: Quality Assurance Manager
Reports to: Chief Executive Officer
Contract type: Permanent
Hours: Part-time (0.5 FTE, 18.75 h/w), flexible working arrangement possible
Location: Wallingford, UK
Reference: PPL QAM
About the company
P1vital Products Ltd is a Digital Health SME specialising in the development of software products for the pharmaceutical and healthcare sectors, with a recognised pedigree in mental health. We have developed two innovative software products; one now in growing use by pharma, biotech and academic partners, and the other recently launched in a real-world implementation in the NHS. Combined with an increasing project portfolio, we are now recruiting a Quality Assurance Manager on a permanent and part-time basis.
Role and responsibilities
You will be responsible for ensuring that Quality Management System (QMS) requirements are effectively established and maintained in accordance with Medical Device, Clinical Trial and GDPR Regulations.
- Maintain QMS including Policies and Standard Operating Procedures (SOPs) to ensure updates in accordance with current regulations and best practice.
- Prepare, host and manage all regulatory inspections / client audits.
- Manage supplier assessment process and conduct supplier audits, as necessary.
- Conduct internal audits to ensure compliance with QMS.
- Appointed Data Protection Officer responsible for GDPR compliance.
- Train employees in all aspects of QMS, Policies and SOPs, as required.
Skills and experience
- Educated to degree level or equivalent.
- Experience in Quality Assurance within life sciences and/or medical device industry (required).
- Expertise in developing and maintaining a QMS to meet Medical Device, Clinical Trial and GDPR Regulations and other applicable standards (e.g. ISO 13485, ISO 14971, Good Clinical Practice).
- Prior knowledge of FDA 21 CFR Part 11, Computer validation methodologies (preferred).
- Strong communication skills (written and verbal).
- Salary range: up to £60,000 (full time equivalent) depending on experience
- Full company benefits and package
If you are interested in applying for this role please email your cv with a cover letter to email@example.com.