Share

Support supplier selection, qualification, supplies development, and supplier process validation/controls. Review and approve inspection sampling plans. Drive source inspections for select parts.

Job Responsibilities

  • Collaborate with Product Development and Operations in selection of new suppliers.
  • Perform thorough supplier audits of processes and QMS driving improvement where necessary.
  • Collaborate with Product Development and Operations in supplier development by evaluating and developing supplier processes through process and/or tooling validations, conducting supplier review meetings, and training as needed.
  • Drive corrective actions/supplier corrective action requests (SCAR) within suppliers’ management process.
  • Demonstrate knowledge of requirements and standards such as 21 CFR 820, ISO 14971, ISO 13485, ISO 9001, and others as applicable.
  • Knowledge/keep of specification development, industry standards, geometric dimensioning and tolerancing (GD&T), etc.
  • Knowledge of inspection/measurement methods and technology.
  • Maintain supplier records, including performance metrics and reports.
  • Will be working with cross functional groups including Doc Control, Purchasing, R&D Engineers, Quality Engineers, and Manufacturing Engineers.

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).
  • Familiar with 21 CFR 820 and ISO 13485 requirements and practices for purchasing preferred.

Skills and Abilities:

  • Attention to detail
  • Outstanding written and oral communication skills
  • Work effectively on cross functional teams to establish appropriate processes
  • Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports; and give oral presentations
  • Strong organizational and time management skills

Travel Requirements:

Up to 25%

Relocation:

Not Available

Location:

Company Headquarters in Valencia, CA

Company Description:

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

Please address all inquiries to careers@setpointmedical.com.