Senior QA Engineer

Job Title: Senior QA Engineer
Department: Quality Assurance and Regulatory Affairs (QARA)
Reporting to: Quality Assurance and Regulatory Affairs Manager

Welland Medical, one of the leading ostomy brands in the UK and worldwide, specialise in the design, development and manufacture of innovative stoma care appliances and accessories. Welland Medical is renowned for manufacturing ground breaking solutions that enhance people’s lives, every day. Situated in a purpose-built state of the art research, development and manufacturing facility, Welland Medical has a growing workforce of over 240 skilled colleagues. Part of the privately owned CliniMed Group, which established in 1982, provides specialist products and services to the healthcare market.

Overall Purpose of the Role:

A key liaison between all functional Departments, the Senior Quality Engineer is responsible for ensuring that all products and processes meet requirements of the current ISO13485 Quality Management System and Medical Device Regulation (MDR) EU/2017/745.

The Senior QA Engineer will lead and manage the QA Engineers on shift and provide support and guidance to the Quality Engineers and Quality and Regulatory Affairs Engineers as required.

The Senior QA Engineer shall cover in the absence of the Quality Assurance and Regulatory Affairs

Manager. This is a key role working closely with the Quality Assurance and Regulatory Affairs Manager, Engineering Manager and Operations Management Team.

Key Responsibilities:

• The Senior QA Engineer is responsible for reviewing and analysing quality data, auditing processes, identifying and implementing system improvements, managing corrective and preventive actions (CAPAs) and lead CAPA teams as necessary, developing and performing investigation and test methods for product testing and investigations, writing and updating procedures as required to ensure compliance to the current ISO 13485 Quality Management System and MDR.
• Lead the QA Engineering team of two, to provide support to the manufacturing operations department by driving process excellence and product health.
• Advise QARA colleagues and provide support on the key areas listed below.
• Ensure that all Welland products comply with the current ISO13485 Quality Management System and MOR to maintaining a proactive compliance culture throughout the organisation and assist quality activities to achieve company KPls.
• Advise Welland colleagues on quality system requirements, providing support and training were necessary to ensure the impact of quality Is fully comprehended.
• Maintain the non-conformance reporting system, driving timely disposition and closure.
• Support the Shop Floor to ensure manufacturing quality issues are dealt with and closed out in a timely manner.
• Plans and conducts sampling, analysis, inspection, tests, and/or integration of test methods to assure the quality of assigned products or components.
• Develop Inspection and test methods and participates in the assessment of returned products.
• Track and reports on quality metrics.
• Advise on changes and their implementation and provides training, tools, and techniques to enable others to achieve quality.
• Champion and utilise lean and risk management principles throughout the manufacturing process, using analysis tools eg DMAIC, 8D, IS/IS Not, S Whys, FMEAs to determine most appropriate issue resolution actions.
• Leads and/or participates in Quarantine meetings. Identify non-conformance trends and develop and administer technical investigation and corrective action programs to resolve recurring quality problems.
• Oversee customer complaints investigations, root cause analysis and ultimate resolution of product failures. Evaluate the actual potential product failures and update risk management files as needed.
• Alongside Purchasing and Engineering, manage supplier quality issues and improvements through supplier surveillance, incoming Inspection and Non-conforming material review.
• Contributes to the development and implementation of product Inspection and test plans including verification and validation of products and processes.
• Manage or assist with new material or equipment, processes and products validations.
• Support New Product Development (NPD) as necessary.
• Lead Continuous Improvement (Cl) projects or assist with continuous improvement initiatives with regards to key KPls.
• Carry out and manage internal or supplier audits to ensure compliance of systems, processes and product. This will require some overseas travel.
• Support Notified Body and Customer audit activities relative to Product, Quality Management System and MDD/MDR requirements.
• Represent the Quality Assurance and Regulatory Affairs Department at external and internal meetings and training events.

Other Duties

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

Health and Safety:

The company has a Health and Safety Policy, which outlines responsibilities of both the employer and employee in respect of health and safety. All colleagues are required to be aware of this policy and comply with its content

Quality:

Quality is an integral part of the company’s mission to deliver innovative products and service. All members of staff are responsible for operating and promoting the development of quality standards and procedures

Lean Manufacturing:

The company is committed to a culture of Lean Manufacturing. All Welland colleagues are expected to take ownership of tasks and learn the various techniques of Lean Manufacturing to support the company’s objectives.

The Senior QA engineer will be encouraged to use lean manufacturing techniques to continuously improve quality and efficiency.

This is a description of the job as it exists at present. All Job Descriptions are liable to variation in order to reflect any future role/obligations change and employee development.

For more information, please contact our recruitment team at recruitment@wellandmedical.com.

A covering letter and CV are required with all applications.