QA Engineer

Job Type:
Permanent
Job Sector:
Engineering
Region:
South East
Location:
Basingstoke
Salary Description:
Competitive
Posted:
04/02/2020
Recruiter:
TalentSpa Recuitment
Job Ref:
B/QAEng

QA Engineer

Location: Basingstoke

Salary: Competitive

Job Type: permanent position

Hours: 36.5 hours per week, Monday to Friday

Blatchford is a multi-award-winning manufacturer of some of the world's most advanced prosthetic technology, bespoke seating solutions and orthotic devices. Our evidence-based approach and commitment to continuously challenge possibilities ensures our mobility solutions prioritise the wellbeing and long-term health of our users. Through science, technology, and maintaining a clear focus on people, we make mobility possible.

The role of the successful QA Engineer is to develop, improve and maintain Blatchford's Quality Management Systems (ISO9001:2015 and ISO13485:2016) whilst meeting our Regulatory responsibilities as part of the Quality Assurance team.

Responsibilities of the QA engineer:

* Implementation, maintenance, continuous improvement and support of Blatchford's Quality Management Systems (in line with ISO9001:2015 and ISO13485:2016) and the Medical Device Directives/Regulations).
Including:

* Management Review
* Key Performance Indicators
* Management of Quality Documentation (Procedures and WIs)
* Internal Auditing for Prosthetics/Clinical Services/Seating/Orthotics.

* Be a key resource in our transition to the new European Medical Device Regulations.
* Host/participate in external Quality audits in support of ISO9001:2015 and ISO 13485:2016 certification.
* Participate in Post-market Product Surveillance/Vigilance and Customer Feedback/Complaint activities in order to ensure patient safety, drive product improvements and customer satisfaction, liaise with Regulatory Authorities where appropriate.
* Supplier Quality Assurance.
* Staying up to date with quality assurance techniques, principles and best practice with a view to improving Group QA.
* Ensuring new product compliance auditing for "release for sale" sign off, as part of the company new product cross functional teams.

Requirements of the QA Engineer:

Therefore, we are really looking for someone who has experience in a Quality Assurance role, which includes auditing. The successful candidate will also have good working knowledge of ISO 9001:2015, MDD and EU MDR Regulations. Working knowledge of ISO 13485:2016 standard, FDA and other international medical device regulations is desirable however not essential.

Benefits of the QA Engineer:

This is a permanent position and the core working hours are 36.5 hours per week, Monday to Friday. In return, we offer a competitive salary package and excellent benefits, including an early finish on Fridays!

If you feel like you meet the above criteria of the QA engineer, please apply now!

Contact Details:
TalentSpa Recuitment
Tel: 0844 8700 926
Contact: .
Email:

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