Quality Engineer

Job Type:
Job Sector:
£35,000 to £40,000 per annum
Job Ref:

QA Engineer Bridgend Up to 40K
Are you a proven Quality Engineer?
How about an Engineer who is driven by statistics and demonstrates a strong analytical approach?
If so , read on.
I am recruiting for a fantastic medical device company in Wales , they are galvanizing the industry, and this will be an opportunity to be part of something big, something great, something…Quality.

Feel free to review the below and let me know if you are ready to apply today.
The Role

Lead and drive QA initiatives within area of functional responsibility.
Provide quality input and support to the manufacturing, engineering and product development functions.
Establishing inspection standards, plans, frequencies and test methods.
Performing an active role in further development and continuous improvement of the Quality Management System.
Work closely with operations and the business functions to ensure quality performance of product and processes.
Investigating root cause of quality issues and following through with timely and effective corrective actions to prevent re-occurrence for customer and internal issues.
Maintain KPIs for monitoring of process quality, perform analysis and interpret trends, taking appropriate action as necessary.
Develop understanding of risk management practices and concepts within the Quality team, to become proficient in process & product risk assessment.
Optimization of inspection methods and sampling. Support First Article Inspections.
Participate and interface in internal/external audits providing effective narrative and description of topic of expertise.
Assist in the development and review of process and equipment validation/qualification. Build proficiency in validation processes.
Responsible for initiation, containment and support for Product Holds for potential Non-conforming product escapes.

The Essentials

Degree in Science / Engineering or equivalent.
You will be confident with statistics, analytics and problem solving.
You will hold an industry or role relevant background and can demonstrate previous Quality experience.
Working knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.
Manages change well and adopts a continuous improvement orientation to the role.
Ability to demonstrate the strong voice of Quality when dealing cross functionally.
Excellent communication skills, both written and oral are essential, along with excellent planning skills with attention to detail.
Use of Lean Six Sigma methods including Minitab a distinct advantage.

The Desirables
Awareness of Quality System Regulation (21 CFR Part 820), ISO 13485 .
Experience in new product introduction and manufacturing process transfer

Medical Device , Quality Engineer , Validation Engineer , Validation, Statistics,
Wales Cardiff Bridgend Newport

STR Limited is acting as an Employment Agency in relation to this vacancy.

Contact Details:
Tel: 02392322375
Fax: 023 9237 4445
Contact: Richard Bateman

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