Our client, a cosmetic production company is currently looking to recruit a Quality Assurance Assessor. Must have ISO13485 and technical knowledge of the medical / cosmetic world. Reports to the QA Manager. 2-3 days per week with a salary circa £35k - £40k pro rata, flexible schedule to suit you. With the chance that the position might become fulltime if that suits you.
Purpose
- Act as a key contributor to the effective collaboration between the product engineering, manufacturing and quality functions; providing specialist expertise in the areas of Quality Assurance, Regulatory Compliance, Design Controls and Risk Management – particularly around technology transfer
Duties and Responsibilities
- Understand the requirements of Design Control and facilitate design review meetings
- Provide Quality/Engineering support with focus on Process validation to the design and transfer into manufacturing team
- Preparing/Reviewing Master Validation Plans, Design specifications, and risk management documentation
- Work within project teams to establish process controls that ensure the product is manufactured in a compliant manner
- Providing ongoing communication, and documentation to the design and technology transfer teams to ensure compliance with design control documentation
- Ongoing monitoring of the companies quality objectives and performance metrics
- Collaborate with the operation function to help facilitate the successful execution of the new product/project development project
- Work closely with Quality Management, assisting in continuous development of the QMS
- Engage early in the product development cycle with validation engineers
Education and Experience Required
- Level 8 Degree in Quality or Engineering
- Experience in CMM/Metrology
- At least 5 years experience in Quality or GMP environment (in the Medical or Cosmetic Industry is ideal)
- Good knowledge of Design Control and Validation required
- High level of interpersonal communication and organisational skills required
- Ability to take initiative, influence cross-culturally and functionally, organise and prioritise own work