Join a Team That Changes Lives (and has fun doing it!)
The manufacturing team of a large medical device company is looking for someone who takes Quality and Compliance as serious as we do.
If you have an affinity for building relationships while strictly adhering to ISO 13485 requirements, this could be the team for you.
This individual will be responsible for providing quality oversight and support to vendors and internal teams alike to ensure that our life-changing products are developed in compliance with company SOPs and other regulatory requirements.
The ideal candidate has a knack for problem-solving, an eye for small details, and is meticulous in their record-keeping.
As a Supplier Quality Engineer Consultant, you'll be the first line of defense against non-compliance to help us maintain our incredibly high safety standards.
Responsibilities :
- Manage control of external suppliers and contract manufacturers to ensure supply of quality materials.
- Act as the quality representative in external supplier communications.
- Lead supplier qualification program and maintain an up-to-date Approved Supplier List.
- Generate supplier related metrics and execute data driven improvements.
- Communicate supplier related issues to responsible supplier representative and facilitate the resolution of supplier issues through quality process e.g., SCAR.
- Support improvement of supplier processes through audits and feedback to suppliers.
- Collaborate with suppliers on creation and maintenance of quality tools such as FMEAs, control plans.
- Support improvement of Standard Operating Procedures and / or Work Instruction as part of the Quality System procedure.
Qualifications :
- 7+ years of relevant experience in Medical Device environment.
- Working knowledge of current ISO 13485 standard, QSR, and ISO 14971.
- Bachelor's Degree in Science or Engineering
- Ability to work in a team environment, manage multi-tasking, and disciplined in completing tasks on schedule.
- Excellent written and verbal communication skills.
Bonus Points for :
- A Master's Degree in Engineering or related studies
- Remediation experience (DHF, Regulatory compliance, e.g., EU MDR, UKCA)
- Experience with Trackwise
Why Choose Us?
Our people-first culture prioritizes the well-being of not just our future patients, but the professionals building our products.
We believe that collaboration, flexibility, and innovation will unlock the solutions for a healthier world.
We'd love to have you join an organization that makes a difference every day. Apply now!
IND123
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