Quality Engineer

To be considered for this position, please complete the following application: Quality Engineer

SUMMARY:

As a successful quality engineer, you will bring a proven track record of improving manufacturing quality through internal process improvement. Ideally, you have worked in corporate quality engineering in the medical device (or similarly regulated) field and are excited to bring strict quality regimentation to a business experiencing explosive growth. You have experience in quality control as it relates to mechanical, electrical and even biological (fluidic) components in a manufacturing environment.

In this fast-paced, startup environment a successful candidate will possess strong initiative and self-starting qualities with adaptability to any task. The candidate should fully understand that this position is not a “desk job” and that in the exciting times our business is experiencing there is no person here with a single duty. A QE may go from writing a work instruction to measuring components to designing solutions with the engineering team and further.  This position will report directly to the Head of Quality.

 

RESPONSIBILITIES:

– Develop inspection plans for custom components received for production

– Improve current measurement and inspection practices

– Assist in creating/updating work instructions for production processes

– Continually develop our QMS and assure compliance with regulatory requirements

– Work with engineering teams to develop tooling and new processes

– Manage/coordinate internal Material Review Board

– Root Cause Analysis on bad parts/bad assemblies

– Update DFEMAs and PFEMAs to align with advancements/updates to the thermocycler

– Manage the design package/Design History File for the thermocycler

 

QUALIFICATIONS:

– BS in Mechanical/Electrical/Biomedical Engineering

 

REQUIRED EXPERIENCE:

– 3-5 years’ minimum experience in a quality engineering role

– Corporate quality in a regulated environment (ISO:9001, AS9100D, ISO:13485, 21CFR820)

– Measurement methods/metrology

 

Due to ITAR compliance, this position requires candidates to be a U.S. Citizen, Permanent Resident Alien, or Protected Individual per 8 U.S.C. 1324b(a)(3)

Biomeme is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law

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