Quality Engineer- Medical Device

Placed: 08/12/17
Region: Oxfordshire
Location: Crawley
Category: Jobs


Content of the advertisement:

MEDICAL DEVICE QUALITY ENGINEER -CRAWLEY - PERMANENT £45K-£50K + PACKAGE
I am recruiting for one of the leading innovators in the medical device market.
By developing both cutting edge equipment and software they are not only enhancing but saving lives. They are one of the most respected companies in medical device and their technology has a presence in hospitals across the world.
As a Quality Engineer, you will have a practical role in the day to day operation of the Quality Assurance Team. This will include: Working with Subject Matter Experts (SME's) to maintain and update Policies, Procedures and processes to ensure ongoing compliance to the standards, regulations and my clients QMS. This is a hands on role that will require a solid understanding of ISO , IEC and CFDA regulations. You will need to be able to communicate effectively and have a passion for quality that is evident with your working approach. Your working day will be at an exceptional facility that offers a fantastic working culture and the ability to shine day after day.

Required Skills/Experience:
Proven Track record of conformance to regulatory requirements including as appropriate ISO9001, ISO13485, 21 CFR part 820, Medical Device Directive.
Knowledge of ISO 14971, CFDA, Japan PAL, Health Canada, ISO14001, ISO27001 & ISO18001 / ISO45001.
Demonstrate the ability to apply Quality Management practices in an efficient and effective way while ensuring compliance.
Change Agent supports continuous improvement / compliance to regulations.
Work as an integral member of a cross functional team to support the development and implementation of new / modified medical device equipment.
A structured approach to problem solving with an appreciation of quality tools & techniques.
Knowledge of Lean and 6 sigma tools and techniques as required including DFMEA, PFMEA, SPC, design of experiments and root cause analysis (DMAIC,8D).

Beneficial Skills/Experience:
Exceptional interpersonal and communication skills. Excellent attention to detail. Ability to work on one's own initiative. Demonstrate sound judgment/rationale. Excellent report writing and reviewing skills.
Certified Lead Auditor ISO 13485 / 9001 preferred
Knowledge of 'Agile' methodologies, such as SAFe and TIR45.
HND/Degree in an engineering related subject or a formal engineering apprenticeship with several years demonstrated experience in a similar role.

Please apply today for an information discussion about the role.

Commutable from: Crawley, London, Brighton, Croydon, West Sussex, Surrey, Kent
Key words ; Quality, Medical Device, ISO, Regulatory, Engineer, Audits

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

Price / Salary: £45000 - £50000/annum