Junior QA Engineer

Welland Medical brings to market the best and most innovative products that enhance the lives of people living with a stoma across the world. Investing in the most talented people, collaborating to create world‑class, ground‑breaking products and services devoted to improving peoples’ lives. We are passionate about making a difference in the world. Our reputation is based on a tradition of improvement, ethical leadership, and total commitment to quality and safety.

Welland Medical, established in 1988, is part of the CliniMed Group, and has over 250 colleagues committed to enhancing people’s lives.

Main Duties and Responsibilities

As a Junior QA Engineer, your main responsibilities and duties will include :

• Ensure the QMS is adhered to and that ISO standard requirements are met and maintained
• Calibrate Production Equipment as necessary in a timely manner and maintain the calibration database Maintain and report on quality metrics
• Support Manufacturing to ensure quality and material issues are dealt with and closed out in a timely manner.
• Assist with new material, Equipment, CSV, and Process validation as necessary
• Assist in the improvements of QMS against ISO 13485
• Support training to site staff on Quality System procedures as required
• Assist with Corrective and Preventive Actions (CAPAs) and support CAPA teams as necessary
• Assisting the business in closing CAPA and Non – Conformances
• Providing QA support and approval of CAPA and Non‑Conformances
• Assist in Quality Audits (Internal, Supplier) against ISO 13485
• Support for logging, monitoring, and closing audit actions, Internal, and Supplier
• Work with manufacturing teams (Operations, Engineering and Planning Departments) in driving through the focus, teamwork and support required to ensure the delivery of all key manufacturing KPI’s.
• Support with customer complaints and complaint reporting
• Assist Incoming Inspection sampling and analysis of raw materials
• Support in post market surveillance (PMS) and post market clinical follow up (PMCF) activities
• Contribute to Lean Manufacturing Projects and communicate progress to CI Management with regards to key KPIs.

A degree of flexibility is needed, and the job holder may be required to perform work not specifically referred to above and which will be appropriate to the level of the role.

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