Support supplier selection, qualification, supplies development, and supplier process validation/controls. Review and approve inspection sampling plans. Drive source inspections for select parts.
- 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.
- 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
Up to 25%
Company Headquarters in Valencia, CA
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 firstname.lastname@example.org.