Description
REFERENCE SDQE
Job Title: Senior Design Quality Engineer
Department: Quality
Location: Leeds
Contract: 6 months rolling contract
My client is looking reporting for a Senior Design Quality Engineer with experience of process implementation.
My client is going into partnership with another organisation and want to ensure when they are manufacturing there product everything goes as smooth as possible.
The Senior Design Quality Engineer shall lead product development efforts.
The job holder will lead product development activities from a Technical Quality perspective by preparing appropriate Risk Management plans, reviewing Design Control plans and overseeing qualification & validation process with internal manufacturing sites and/or external suppliers.
- They are looking for people who have process implementation experience
- Someone with experience of Hip replacement/Medical Device
- A degree level or similar qualification in mechanical or industrial engineering.
- Creation and/or maintenance elements of Quality Systems.
- Minimum 5 years experience in a quality role within a regulated industry.
- Proven ability to successfully introduce new product development in the Medical Device Industry.
- Proven knowledge and ability regarding product verification and process validations.
- Proven knowledge of FDA and MDD GMP requirements regarding medical Devices.
- Proven experience and training in Mechanical Engineering processes.
- Knowledge and understanding of validation techniques such as risk assessment, validation planning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), change control and process verification.
- Full understanding and experience of internal audit administration, CAPA and operational/executive management review.
- Must have a good understanding of Geometric Dimensioning and Tolerancing and be fully conversant with engineering drawings.
- Have the proven ability to interpret and create engineering specifications and procedures