Quality Assurance Engineer

Rancho Cordova - California - United States - Life Sciences & Health Care - Medical devices - Embedded Software - Academic Bachelor

A career in quality assurance is profoundly satisfying if you are the type of person who wants to know the full story, from first beginnings to a beautiful end. The satisfaction comes from assuring and auditing processes and products right through, finding the bumps in the road, and making the journey seamless. If that sounds like you, take a look at this opportunity based in Rancho Cordova, California.

Feel free to contact

Sierra Brown, Account manager

Apply now

About this role

This role is focused on end-to-end quality assurance related to manufacturing processes (internal and external), including quality control, storage and distribution of materials, components, sub-assemblies, through to completed products and their supply chain. There is oversight required for introduction/validation of new/changed manufacturing processes and associated quality systems, as well as remediation to any non-conformances revealed by the auditing process. There’s support required for change controls, CAPA/SCAR, NCR, to ensure progress is reported and any project delays identified.

There’s a strong thread of compliance running right through, to meet regulatory requirements, and/or procedures for regulated products/businesses. Support is required for regulatory actions and product containment activities (e.g., DPIAs, product holds, etc.). There’s also a support element for internal and external audits and inspections, so you'll need to be comfortable in different teams. You'll also be providing support (through Change Controls, CAPA/SCAR, NCR) for operations on NPI/Sustaining projects, correcting issues that may delay completion, advising project status.

About you

You have an understanding of medical terminology, and are familiar with standards of care and disease states.

You’ll have your ASQ Certification as CQE or DfSS/DMAIC Green Belt/Black Belt (or other recognized equivalent Accreditation bodies). Experience with Windchill/Trackwise or CATSWeb is highly desirable, but there may be opportunities for training. There may also be some travel required, so you’ll get out from behind your desk from time to time.

Must haves

  • Bachelor's degree in a Technical, Science, or Engineering discipline
  • 5+ years’ experience in quality assurance/operations in a medical device industry

In addition you’ll have a detailed understanding of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 13485:2016.

This is a great opportunity if you are looking gain further your experience in a quality assurance role. If you are ready for a step up, send us your resume today.

What we offer

Why work through Brunel? We start with competitive rates, a comprehensive benefits package and a 401k. We provide flexibility of work with the security of an open-ended contract. With Brunel you will gain experience and expertise, building on your skills and developing your career further.

About us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services. Join us today.

Summary

  • Vacancy number: PUB206130
  • Location: Rancho Cordova
  • Market: Life Sciences & Health Care
  • hours per week: 40
  • Branche: Medical devices
  • Education level: Academic Bachelor
  • Area of Expertise: Embedded Software
  • Closing date: Saturday, May 18, 2019
Apply now

Feel free to contact

SB

Sierra Brown

Account manager Brunel Energy USA Houston

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