Quality Assurance role (Part time)

• Act as the local QA Representative.
• Maintain compliance to applicable quality and regulatory requirements.
• Maintain compliance to ISO13485 and sustained a certified quality system.
• Perform all activities assigned to the Quality Assurance Function, including but not limited to Management Review, CAPA, Internal and External Audits, Product Complaints, Document Control, record Retention, Training, Calibration, Label Approval, and Inspection.
• Perform all activities assigned to the Quality Control Function Monitor, including but not limited to processes related to product quality, handle the non-conforming product process assuring segregation and disposition of suspect product, inspection and release, warehousing controls, receiving inspection, and other activities associated with product acceptance. Oversee Manufacturer Management and Handle QA Receiving process.
• Support procedure pack assembly processes and controls. This includes:

• Assure all aspects of the kitting or packaging process are in conformance to process requirements
• Verify labeling for accuracy and conformance,
• Inspect parts and assure all components of the packaged product are correct as per the production order and specification
• Complete and maintain all applicable records (e.g., Device History Records).
• Other tasks as assignment by Management.

• Bachelor's degree in a technical discipline.
• Two to three years' experience in a medical device regulated facility.
• Basic understanding of both legal and scientific matters
• Ability to grasp new concepts quickly and to assimilate and evaluate scientific data
• Analytical and problem-solving skills
• Strong written and oral communication skills
• Attention to detail
• IT skills, particularly in relation to using databases and familiarity with commercial software
• The ability to work under pressure and to strict deadlines
• The confidence to report to management
• Team-working skills and the ability to lead and motivate others
• Project-management skills
• Integrity and a professional approach to work
• Able to use a personal computer.
• Able to bend, reach, and occasionally lift up to 14 kg.
• Office and lab environment and occasional exposure to manufacturing plant environment, with some abnormal variations in temperature, unavoidable fumes, noise, dust and atmospheric conditions.

CREGG Recruitment