Staff Engineer, Supplier Quality Engineering

Staff Supplier Quality Engineer

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.

Additional responsibilities include:

• 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 company organization
• Serve as a process owner and drive standardization of SQ-related processes
• Additional duties, as assigned

Education / Work Experience

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)

Preferred Qualifications:

• ASQ CQE/CMQ/OE/PE certification
• Demonstrated working knowledge to positively influence supplier quality performance
• Lean Six Sigma Green Black Belt certification
• 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
• Travel required

Additional details from intake call:

• Travel is required, contingent would be traveling for company required audits (mostly across Midwest short trip, limited notice so needs to be flexible)
• Remote contingent worker (Michigan, Indiana, Ohio, Illinois preferred)
• In the beginning, role will be focused on collaborative work. Once trained, contingent will have autonomy in work but manager will be involved to ensure key KPIs are being met
• 40 hours weekly
• Preference to candidates who have experience using Track Wise
• Staff engineers will be set up with mentors and working with a team of 10 engineers (very tenured)

Top 4 Must haves:

• 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 (will be representing company during travel)
• 3-5 years Regulated industry experience required (order of preference
  -Medical, Pharma, Automotive)
• 3-5 years supplier facing experience

Top 4 would be nice:

• Basic knowledge of FMEA, validation programs and SPC processes (statistic process controls)
• Quality engineering experience
• Understanding of manufacturing process