We are looking for an experienced Senior Quality Engineer to join a prestigious medical manufacturer based in Plymouth.

What is the main purpose of this role?

The Senior Quality Engineer is responsible for ensuring products meet SQCD requirements, that product issues are promptly investigated, with adequate corrective/preventive action implemented and that the CAPA systems are operating effectively.

What are the key responsibilities?

* To support the General Manager - Quality in devising and establishing the company's quality procedures, standards and specifications, ensuring that these controls are properly developed, implemented and maintained

* To support the General Manager - Quality in driving the importance of Quality and a collaborative culture within the team across the network.

* To support the General Manager - Quality by collaboratively working with departments by providing guidance and leadership to ensure all products represent the maximum quality and reliability attainable.

* To review and approval any technical / engineering documentation correctly and in a timely manner, ensuring all processes are followed.

* To communicate effectively with the Operations team in development activities, collaboratively working together to ensure any areas of concern are rectified.

* To lead and manage any customer complaints, ensuring all processes are followed and documentation is completed correctly and in a timely manner.

* To participate and lead problem solving activities, collaboratively working with other areas of the business.

* Working with other departments where necessary to establish quality requirements from external suppliers.

* To create, manage and work towards individual, departmental, team and site KPI's.

* Shall implement and work to all applicable regulatory and quality requirements as stipulated within the Quality Manual, Quality Policy, and Quality Objectives

* Shall implement and work to all applicable Health, Safety and Environmental requirements as stipulated within the HSE Manual, HSE Policies, and HSE Objectives, including raising Hazard ID's

* To effectively People manage any direct reports on any employee relation topics including performance, training, recruitment, formal meetings, engagement and communication.

What skills and qualifications are required?

* Proven experience in a Quality Systems and/or Engineering role within an Electro-Mechanical or Electronics or Sterile Medical Devices Manufacturing environment is desirable

* Minimum of five years quality managements experience ideally within a medical device manufacturing facility is essential

* Certified Lead / Principal Auditor Experience in QA is desirable

* Thorough understanding of Quality approaches & techniques relating to the Manufacturing Business is essential

* Lead audit experience in regulatory body inspections e.g. FDA, MHRA is desirable

* Comprehensive Knowledge of formal Quality Systems e.g. ISO 9001, Iso13485 and awareness of MDSAP is essential

What does this company offer?

In addition to a competitive salary, there are great benefits such as 25 days annual leave, which increases over length of service; health care plans and free support; great pension scheme; life assurance; refer a friend scheme worth £1,000; Christmas gifts and savings club; cycle to work scheme; free uniform and parking; an appreciation platform where you can access exclusive discounts; an entire catalogue of training for you to access; discounted gym membership - plus much more!

Your benefits

* Generous Annual Leave Entitlement

* Healthcare Plans and Support

* Life Assurance

If you have the experience required and are currently looking for a new challenge, then please submit an up to date CV by using the 'apply' button below.

For informal chat, please phone (phone number removed) and ask for Laura Meadows. Many thanks for your interest