Quality Assurance Assessor

UK - Brackley Operations

17 Apr 2021

UK - Brackley

Operations

Engineering

Part Time

1

5 years

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