Website inSync Staffing
inSync Staffing
Company : inSync Staffing
Supplier Quality Engineer
Location: Campbell, CA
Pay: $65.00 – $78.00
3 month+ assignment
" Collaborate with suppliers, contract manufacturers, and business partners to ensure robust materials, components, and processes exist.
" Lead supplier qualification, audits, requalification, and supplier quality agreement activities.
" Own and drive Supplier Quality projects, initiatives, and continuous improvement efforts.
" Partner with Procurement, R&D, Operations, and Supply Chain to resolve supplier-related issues and prevent disruptions.
" Monitor supplier performance metrics, identify risks, and drive improvement actions.
" Manage supplier corrective action processes (SCARs), including tracking, aging metrics, and effectiveness.
" Support and/or lead supplier-related CAPAs, NCRs/NCMRs, and investigations. Docusign Envelope ID: A77B71D5-5F44-43A6-9AE8-60D5917B7538
" Conduct deep failure analysis that extends to supplier components, to find true root cause and drive corrective actions.
" Implement and manage supplier change control processes, including impact assessment and approvals.
" Lead component and supplier qualification and change projects.
PRODUCT / PROCESS QUALITY ENGINEERING
" Serve as liaison with testing laboratories for product testing, deviations, and investigations. " Perform statistical analysis of manufacturing and quality data to identify trends and improvements.
" Support validation and verification activities for product and process changes.
EDUCATION/EXPERIENCE:
" Bachelor s degree in business engineering or related discipline and a minimum of 5 years of related experience; or equivalent combination of education and experience.
" Advanced degree and experience with catheters, endovascular/neurological devices is highly desired.
" Experience in medical devices (catheters, endovascular, or neurological) preferred.
" Experience in both product and supplier quality engineering strongly preferred.
" Experience addressing supplier or process issues (CAPAs, NCMR/NCRs, SCARs, etc.).
" Demonstrated knowledge of quality system requirements (FDA 21 CFR Part 820, ISO 13485 or ISO 9001), risk management standards (ISO 14971) and good manufacturing practices.
" Excellent communications skills (both written and verbal).
" Proven ability to provide thorough and meticulous review of documents.
" Proven ability to write clear, concise, and well thought out technical documentation with focus on failure investigations and inspection procedures.
" Strong ability to perform multiple tasks concurrently with accuracy.
" Proficiency with Microsoft Office products
" May travel: 20 35% as needed to support field sales and leadership initiatives.
Benefits (employee contribution):
- Health insurance
- Health savings account
- Dental insurance
- Vision insurance
- Flexible spending accounts
- Life insurance
- Retirement plan
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Rate of pay within the stated range will depend on the qualification of the applicant.