Junior QA Engineer

Welland Medical Ltd; Crawley; On-site; GBP 100,000 - 125,000; Full time

Job summary

A leading medical device company in Crawley is looking for a Junior QA Engineer. The ideal candidate will ensure compliance with ISO 13485 standards, calibrate production equipment, and support manufacturing quality issues. Applicants should have a degree in a relevant field and a commitment to quality practices. For more information or to apply, please contact us via email.

Qualifications

• Understanding of ISO standards, specifically ISO 13485.
• Degree in a relevant field.
• Flexibility and readiness to perform additional tasks as needed.

Responsibilities

• Ensure compliance with QMS and ISO standard requirements.
• Calibrate production equipment and maintain calibration records.
• Support manufacturing teams in resolving quality issues.

Skills

ISO 13485

Quality Management System (QMS)

Calibration

Corrective and Preventive Actions (CAPAs)

Lean Manufacturing

Education

Degree in relevant field

Job description

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
• Assist in closing CAPA and Non-Conformances
• Provide QA support and approval of CAPA and Non-Conformances
• Assist in Quality Audits (Internal, Supplier) against ISO 13485
• Support logging, monitoring, and closing audit actions, Internal, and Supplier
• Work with manufacturing teams (Operations, Engineering, and Planning Departments) to ensure the delivery of key manufacturing KPIs.

Other Duties

• Support with customer complaints and complaint reporting
• Assist Incoming Inspection sampling and analysis of raw materials
• Support post-market surveillance (PMS) and post-market clinical follow-up (PMCF) activities
• Contribute to Lean Manufacturing Projects and communicate progress to CI Management regarding key KPIs.

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

For more information about the role or to apply, don’t hesitate to get in touch with us at [e-mail].