Quality Engineer

Job Title: Quality Engineer

YOU'LL GET A CHANCE TO:

  • Develop training and documentation materials for production (e.g. work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
  • Develop and implement controls and improvements in conjunction with the Operations Manager.
  • Examine manufacturing product quality and compliance issues for production processes prior to final product release based on engineering principles; analyse results, make recommendations, and develop reports. Examine any complaints.
  • Develop, update, and maintain technical content of risk management files.
  • Participate in internal audit and supplier audit programs for relevant ISO’s such as ISO 13485 and ISO 14001.
  • Oversee defect resolution, root cause investigation, and continuous improvement activities.
  • Support FMEA and inspection development to ensure that all failure modes in process have been identified and addressed.
  • Coordinate quality data and reporting of KPIs to drive continuous improvement that feeds into management review.
  • Project activities as required including assigning support tasks; instructing technicians on supporting projects; trains technicians and provide feedback.
  • Participate in site change control activities.
  • Other duties as assigned by management.

Reports to:  Quality Director

WHAT WILL HELP YOU SUCCEED?

Required:

Minimum Level 7 Qualification.
On the job training will be provided for the right candidate.
Strong written and oral communication skills.
Experience working with medical device regulations is desirable.

Desired:

Strong computer skills.
Internal auditor courses for relevant ISO (desired)

Additional Notes

Tasks and responsibilities will vary with all positions and the scope of each role may not be limited to the contents listed on this job description. The employee’s manager is responsible for communicating any changes deemed necessary to the quality department. It is the employee’s responsibility to adhere to company procedures and GMP in Croom Precision Medical as part of their job description.

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