Job Description
MAIN PURPOSE
CPL Life Sciences are seeking a skilled and experienced quality specialist to oversee the quality activities in related to medical device products with a focus on IVD kits, procedure packs and medical devices supporting the setup and ongoing compliance to ISO13485 and relevant standards and regulations.
Duties and Responsibilities
Quality Management System:
* Develop, implement, and maintain the QMS in accordance with applicable standards and regulations.
* Ensure continuous improvement of the QMS, to processes, procedures relevant and adoption of best practice.
* Participate & contribute as an auditee & member of the auditee team for external audits.
Verification & Validation:
1. Oversee the validation processes involved in the validation of processes, systems and equipment.
2. Analyse, Plan, Specify and Execute verification and validation activities for Products, Packaging and Manufacturing Equipment.
3. Record test failures and deviations
4. Identify V&V needs/gaps/opportunities within the business
5. Engage effectively with key stakeholders (e.g. Engineering, RA etc)
6. Communicate timeously with Quality and Functional leaders.
7. Produce Test reports, supervise approval process.
8. Ini...