Reference Number: JO-2106-470109
Quality Systems Specialist
Job Type: Permanent
Our client are a growing specialist within medical devices for women’s health based in Manchester.
They have an opening to cover a 1 year fixed term position based as soon as possible.
You’ll assure compliance with ISO 13485 + MDSAP quality requirements through the QMS. This will include management/facilitation of quality actions, continuous improvement, quality planning and administrating the Product Lifecycle Management system. You will also be responsible for maintaining audit readiness for all Quality Systems processes and records.
Experience working in regulated devices industry, knowledge of ISO 13485 and/or extensive experience with ISO 9001 would be a bonus and Experience supporting external audit is highly desirable.
- Manage and facilitate activities associated with the QMS including;
- NCE/CAPA/PDV/EXT/SCAR/IACA management
- Material Review Board
- CAPA Review Board
- Co-ordination of appropriate audit actions
- Risk management
- Manage and facilitate change orders ensuring changes to any documents are correctly approved and controlled.
- Maintain audit readiness for all Quality Systems processes and records
- Define, implement, analyze and report on Key Performance Indicators
- Provide reports to communicate the status of open and aging quality actions.
- Provide support for hosting external / internal audits
- Interface with other departments to ensure implementation of GxP in compliance with regulatory requirements and continuous improvement
- Prepare data to support Quality Management Reviews
- Act as a QA mentor to personnel and provide training where required
Qualifications and experience:
- BSc degree in biological sciences, life sciences or related discipline.
- Experience in vitro diagnostics, medical device or pharmaceutical industries
- Understanding of applicable Quality System Regulations (e.g. ISO 13485:2016 and MDSAP) quality requirements
- Ability to plan and/or oversee quality system/processes, documents, and audits/assessments
- Ability to demonstrate initiative, balanced assertiveness working as a team player
- Excellent verbal and written communication skills
- Ability to manage multiple projects