Quality Engineer
Adaptive Biotechnologies
At Adaptive, we’re Powering the Age of Immune Medicine. Our goal is to harness the power of the adaptive immune system to transform the way diseases are diagnosed and treated.
As an Adapter, you’ll have the opportunity to make a difference in people’s lives. With Adaptive, you’ll create a career highlight through collaboration with bright, curious colleagues working at the apex of innovation and application.
It’s time for your next chapter. Discover your story with Adaptive.
Position Overview
The position is accountable for the applications of industry standard quality practices and tools as applied by Adaptive Biotechnologies. This position is responsible for providing insight to functional groups from a QA perspective for root cause analysis investigations of Nonconformances and CAPAs, identifying GMP process improvements and working with functional groups to implement process improvements. The position requires the ability to deal with multiple projects and tasks utilizing effective written and oral communication skills. Will apply quality systems knowledge, problem solving and judgment skills to ensure the appropriate balance of quality, compliance, and business needs.
Key Responsibilities and Essential Functions
- Develop, review, approve, and maintain Design History File deliverables to ensure regulated devices are compliant with Quality System and Design Control principles
- Evaluate product designs for feasibility, testing requirements, regulatory requirements, manufacturing process requirements, inspection requirements, and material selection
- Identifies and implements opportunities for continuous improvement projects and Corrective & Preventative Action(s) (CAPA). Evaluate if changes have an impact on Design History File to ensure compliance with quality system and design controls principles.
- Support GMP activities pertaining to Incoming Receiving activities and manufacturing operations, including review and approval of Device History Records and supporting Quality Records.
- Review, author, and approve quality system documentation and ensure compliance with internal procedures, GMP requirements, and statutory requirements.
- Interact with lab operations personnel to ensure compliance to company quality systems policies and procedures.
- Provide QA input to functional groups to support investigations and ensure proper closure of nonconformances, CAPAs and Deviations.
- Assist in FDA inspections, Notified Body audits, and other internal and external audits.
- Provide QA input to manufacturing and operational process improvement efforts.
- Assist at manufacturing validation activities, including reviewing and approving IQ/OQ/PQ documents.
- Performs regulatory responsibilities per Good Manufacturing Practices (GMP)
Position Requirements (Education, Experience, Other)
Required
- Bachelor’s degree in Biological Science, Mechanical Engineering or relevant scientific discipline which entails critical thinking, analysis, problem solving skills in addition to math skills for statistical evaluations used in engineering quality into systems and problem solving.
- 2 + years of related experience
- Experience with root cause analysis techniques
- Working experience with FDA 21 CFR 820, EU IVD/IVDR, ISO 13485
Preferred
- Knowledge in ISO 14971 and ISO 62366
- Knowledge in CLIA, CAP, CLEP, and GCP
Working Conditions
May require working under cold conditions.
Compensation
Salary Range: $70,000 - $105,000
Other compensation elements include:
- equity grant
- bonus eligible
Interested in this position, but don’t meet all the requirements? Adaptive is committed to building diverse, equitable, and inclusive teams across our organization. Please consider applying even if your experience doesn’t match all the qualifications; you may be the exact candidate we’re searching for!
Adaptive is not currently sponsoring candidates requiring work authorization support for this position.
Adaptive’s posted compensation information includes a base salary (or hourly rate) range and summary of other available total compensation. The base salary range represents a minimum-to-maximum salary (or hourly rate) available to candidates upon extension of offer. Base salary is thoughtfully considered upon offer and is determined through multiple evaluation checks throughout the interview process, including: a candidate’s ability to meet minimum qualifications (skills/experience/education), a candidate’s ability to thoughtfully address preferred qualifications, current market conditions, and internal pay equity. Listed base salary is exclusive of bonus, commission, equity, differential pay, benefits, and other incentives.
Adaptive's benefits at-a-glance.
If you have a disability and you believe you need a reasonable accommodation to search for a job opening or to submit an online application, please e-mail accommodations@adaptivebiotech.com. This email is created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response.
NOTE TO EMPLOYMENT AGENCIES: Adaptive Biotechnologies values our relationships with our Recruitment Partners and will only accept resumes from those partners who have active agreements with Adaptive. Adaptive Biotechnologies is not responsible for any fees related to resumes that are unsolicited or are received by any employee of Adaptive Biotechnologies who is not a member of the Human Resources team.