The Company
A groundbreaking medical company going through a sustained period of growth
The Role
Provide Quality Engineering support across all aspects of the Quality Management System.
Duties:
• Work collaboratively with other functional areas to effectively investigate and resolve process and product quality issues, deploying appropriate tools to assist root cause analysis.
• Conduct and facilitate Corrective and Preventive Actions (CAPA), Non-Conformances (NC), and complaint activities.
• Participate in the facility's internal audit program and host external audits.
• Work towards departmental and facility objectives.
• Support the supplier evaluation and review system.
• Support the change control process.
• Provide data trending information as required and communicate it effectively to all levels of the business.
• Work collaboratively with the Engineering and Development functions in all aspects of validation.
• Provide Quality Engineering input into the risk management process.
• Provide Quality Engineering input to the design for manufacture process.
• Participate in the establishment of compliant and effective manufacturing processes.
• Support the calibration, maintenance, and training programs.
• Review batch records, ensuring error-free manufacturing and batch release, and improve batch record templates.
• Maintain compliance with ISO13485 and CFR Part 820.
• Support the implementation and ongoing management of an electronic Quality Management System (eQMS)
The Candidate
3+ years of quality engineering experience
Experience in highly regulated environments (e.g., healthcare, aerospace, defence).
Experience in developing and auditing quality processes, documents, plans, etc.
Have a strong understanding if quality procedures and manufacturing processes
Experience in CAPA, NC, complaint, and change control activities.
Understanding of ISO 13485:2016, MDR, UKCA, and 21 CFR Part 820 requirements would be advantages
Ideally an engineering qualification
Medical experience would be highly beneficial
The Package
The salary offered for this position is £40,000- £50,000 for a candidate who can meet all key qualifications and abilities.
We operate and advertise as an Employment Agency for permanent positions and as an Employment Business for contract/temporary positions