Supplier Quality Engineer

• Travel: Travel is required, contingent would be traveling for company required audits
• Type: W2 contract (NO C2C OR THIRD PARTY will be considered)
• Duration:18-month contract
• Pay Rate: Negotiable depending on direct related experience UP to $53 - $56/hour
• Work Authorization: Must be currently in the United States with active employment authorization documents without current sponsorship transfer requirements.

• The Staff Supplier Quality Engineer serves as a liaison between suppliers and company to drive effective continuous improvement to the supply base. Works with internal customers and suppliers to support supplier quality issues and provide technical support for activities related to supplier quality system assessment, performance evaluation and quality improvement projects.
• The Staff Supplier Quality Engineer collaborates with the strategic sourcing, auditing and development groups to understand capabilities and competencies of suppliers to fulfill quality and regulatory requirements.

• MUST HAVE** - Lead Quality Auditor Qualification (ISO 13485, CFR 820 or comparable standard / regulation) – can be expired with experience at previous job but prefer active
• Strong written and oral skills
• 3-5 years Regulated industry experience required (order of preference
  -Medical, Pharma, Automotive)
• 3-5 years supplier facing experience

• Assess and critique supplier processes and control documentation and drive improvement in the supplier QMS
• Support tracking and reporting of KPIs and other metrics associated with supplier performance
• Articulate detailed supplier performance results and trends to appropriate levels of management
• Propose and develop effective quality improvement plans to be implemented at appropriate suppliers
• Maintain and track completion of supplier action plans
• Provide training and problem-solving expertise at company sites and supplier locations, as needed
• Identify and execute cost reduction opportunities at suppliers
• Transfer lessons learned from the supply base to internal functions for inclusion into next generation designs
• Train, mentor and assist in the development of less experienced engineers
• Provide support in third party audits relating to supplier quality engineering deliverables
• May act as a single point of contact for Strategic Business Partners and participate in supplier reviews
• Serve as a subject matter expert, for assigned commodity; share expertise within global organization
• Serve as a process owner and drive standardization of SQ-related processes
• Additional duties, as assigned

Basic Qualifications:

• BSc /
  
  B. Eng. in a science, engineering or related discipline preferred, or equivalent years of experience
• 4+ years of experience in quality, manufacturing, or a highly regulated environment
• Lead Quality Auditor Qualification preferred (ISO 13485, CFR 820 or comparable standard / regulation)

• Demonstrated working knowledge to positively influence supplier quality performance
• Good knowledge of FMEA, validation programs and SPC processes
• Good knowledge of manufacturing processes, prints, tolerancing, statistics and project management
• Strong interpersonal skills, written, oral communication and negotiations skills
• Knowledge and understanding of US and International Medical Device Regulations