Senior Quality Engineer - Supplier

SetPoint Medical

Valencia, CA, US
  • Job Type: Full-Time
  • Function: Engineering QA
  • Post Date: 06/03/2021
  • Website: setpointmedical.com
  • Company Address: 25101 Rye Canyon Loop, Valencia, CA, 91355

About SetPoint Medical

SetPoint Medical is developing novel bioelectronic medicine therapies to treat those who suffer from autoimmune diseases such as rheumatoid arthritis, Crohn's Disease and multiple sclerosis. The company has developed a proprietary and innovative bioelectronic medicine platform consisting of a micro-regulator programmed via a unique prescription pad based interface. This novel therapy has the potential to provide patients and healthcare providers with a safe and efficacious alternative to drugs, while costing payers significantly less than biologic therapies.

Job Description

SetPoint Medical is seeking an experienced quality engineer to work collaboratively in a cross-functional environment to ensure SetPoint Medical’s suppliers establish and maintain the high level of quality to be a Class III medical device supplier . The Senior Quality Engineer will be responsible for the initial evaluation, classification and ongoing monitoring of SetPoint suppliers.

All candidates will be asked to describe in detail their individual as well as team contributions towards supplier management activities within a Class II/III medical device environment.

Job Responsibilities

  • Maintain the Supplier Management infrastructure; proposing and implementing improvements, as required
  • Collaborate with cross functional groups in selection of new suppliers
  • Perform thorough supplier audits of processes and QMS driving improvements, where necessary
  • Collaborate with Product Development and Operations in production supplier development by evaluating and developing supplier processes through process and/or tooling validations, conducting supplier review meetings, and trainings as needed
  • Drive corrective actions/supplier corrective action requests (SCAR) within the supplier management process
  • Maintain all supplier quality records, including performance metrics and reports
  • Current working knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, and other standards as required
  • Other projects as assigned

Minimum Qualifications 

  • BS in Engineering or Scientific field (MS preferred), with 5+ years of work experience in engineering, quality assurance and/or supplier quality
  • Experience working in the medical device or pharmaceutical industry
  • Experience in outsourced contract manufacturing environment is preferred
  • Experience with Process Validations and/or Test Method Validations (i.e., IQ, OQ, PQ, and/or TMV)
  • Quality System Knowledge including 21 CFR 820, ISO 13485, and ISO 14971

Required Skills and Abilities 

  • Work collaboratively and effectively on cross-functional teams to meet compliance objectives
  • Ability to effectively support multiple high priority deliverables at once
  • Outstanding written and oral communication skills
  • High attention to detail
  • Ability to review, analyze, summarize, and interpret data to draw conclusions and make appropriate recommendations and decisions
  • Must be able to write clear, understandable written reports, and give oral presentations
  • Strong organizational and time management skills
  • Ability to take a creative and proactive approach when considering resolutions and/or alternatives
  • Effective interpersonal/communication skills

Company Description

SetPoint Medical is an early-stage medical device company developing the first implantable bioelectronic device for the treatment of chronic inflammatory diseases.

Relocation

Not available

Location

Company Headquarters in Valencia, CA

 

Estimated Hire Date: October 2020

Status: Accepting Applications

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.