To support the Business Unit regarding engineering activities for the ongoing and evolving stability and predictability of the supply chain. Interfacing with internal and external stake holders to appropriately qualify and maintain suppliers for all product lines. Expected tools to meet these requirements include supplier and component qualifications, data analysis, statistical process control (SPC), CAPA and KPI’s, review and trending. Supplier Quality is responsible for supplier product-related root cause analysis, process mapping and impact assessments for change control. Supplier Quality will lead in CMO/Supplier audits and associated downstream actions to meet expectations. As a senior member in the supplier quality engineering team, the senior supplier quality engineer is expected to provide subject matter expertise in supplier management, understand and evolve internal systems to efficiently meet requirements, interface with vendors of all sizes, and provide leadership to the supplier quality engineering team.

Key Areas of Accountability / Responsibility under limited supervision:

• Expected to serve as primary quality contact with vendors of all sizes and complexities
• Own and manage the supplier qualification process and Approved Supplier List
• Develop, document, and implement QA Procedures
• Analyze internal systems for improvement and drive the improvement efforts
• Perform external audits of CMOs/suppliers to appropriate criteria, report findings, and develop and track actions as required.
• Establish and negotiate Quality Agreements with required supply chain partners
• Analyze non-conforming materials and returned goods and recommend disposition and corrective actions
• Prepare, review, and approve technical reports and provide recommendations based on data rationale.
• Develop, lead, and review root causes for non-conformances and deviations
• Review documentation for completeness and accuracy
• Complete other tasks and projects as assigned by the Supplier Quality Assurance Manager
• Lead focused, multidisciplinary teams with clear objectives
• Serve as leader, teacher, and mentor to other supplier quality team members
• Work occasionally in a clean room setting following protective procedural requirements and comply with all safety requirements, including posted placards, SOPs and the Safety Manual.
• Adhere to Quality System procedures, ISO13485, 21CFR part 820 and current regulatory standards.

Knowledge and educational level

• Educational Level: Bachelor’s degree in Engineering or Life Sciences
• Lead auditor certification
• Six Sigma, ASQ QE or CQA Certification a plus.
• Excellent organizational, leadership, decision-making, and analytical skills.
• Excellent written and verbal communication skills, including writing, editing and proofing skills.
• Well-developed inter-personal and teamwork skills to communicate and resolve product quality issues with R&D, Production, Engineering and other departments.
• Demonstrated ability to multi-task resulting in positive outcome for each task assigned or self-generated.

Required level of experiences

• 8-15 years Quality Engineering or Supplier Management within a regulated industry: Medical Device, Pharmaceutical, Biotech.
• Experience with ISO 9001, or ISO 13485, or 21 CFR820 desired.
• Computer literacy (Microsoft Office, Project, Document Management Systems)
• Statistical techniques and software (i.e. – Minitab)

**SNVA Ventures is a proud equal opportunity employer. We cherish diversity and harbour inclusivity. Any discrimination on basis of race, religion, color, nationality, gender, sexual orientation or other applicable legally protected characteristics is forbidden.**

Job Type: Contract

Pay: $50.00 - $70.00 per hour

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: On the road

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