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Sr Supplier Qual Engineer - Exempt

Lancesoft

Minneapolis, MN

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JOB DETAILS
SALARY
$55
SKILLS
Aerospace and Defense, Auditing, Automotive Industry, Biomedical Engineering, Biotech and Pharmaceutical, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cost Control, Cross-Functional, Data Analysis, Establish Priorities, FDA Requirements, GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Industrial Engineering, Leadership, Maintain Compliance, Manufacturing, Manufacturing Engineering, Manufacturing Operations, Manufacturing/Industrial Processes, Mechanical Engineering, Medical Equipment, Mentoring, Onboarding, Operations Processes, Performance Metrics, Problem Solving Skills, Process Capability, Process Failure Mode and Effects Analysis (PFMEA), Process Improvement, Product Development, Product Support, Productivity Management, Purchasing/Procurement, Quality Assurance, Quality Assurance Methodology, Quality Engineering, Quality Management, Receiving Inspection, Regulations, Regulatory Requirements, Risk, Risk Analysis, Risk Management, Root Cause Analysis, Sales Qualification, Software Testing, System Operations, Technical Leadership, Technical/Engineering Design, Trend Analysis, Vendor/Supplier Evaluation, Vendor/Supplier Management, Vendor/Supplier Planning, Vendor/Supplier Quality Management, Vendor/Supplier Selection
LOCATION
Minneapolis, MN
POSTED
Today
Position Summary
We are seeking a highly motivated Supplier Quality Engineer (SQE) to support supplier quality management activities across both New Product Development (NPD) and commercial manufacturing environments. This role is responsible for ensuring suppliers consistently deliver high-quality components, materials, and services that meet regulatory, quality, and business requirements.

The Supplier Quality Engineer will serve as a key liaison between suppliers, Engineering, Manufacturing, Operations, and Quality organizations to drive supplier performance, ensure compliance with Good Manufacturing Practices (GMP), and support the successful transfer of new products into production. The individual will provide technical leadership throughout the supplier qualification process, supplier audits, risk management activities, incoming inspection strategies, and continuous improvement initiatives.

This position requires strong expertise in supplier quality systems, quality engineering principles, risk-based decision making, and cross-functional collaboration within a regulated medical device environment.

Join us in Minneapolis, MN, a vibrant city known for its thriving medical device industry and a great quality of life. Experience a dynamic work environment where innovation and collaboration are at the forefront.
Key Responsibilities Supplier Quality Management
  • Ensure suppliers consistently provide quality products, materials, and services that meet company specifications and regulatory requirements.
  • Lead supplier qualification, onboarding, and approval activities.
  • Evaluate supplier capabilities, manufacturing processes, quality systems, and operational effectiveness.
  • Manage and maintain Approved Supplier Lists (ASL).
  • Support implementation and management of Supplier Owned Quality (SOQ) programs.
  • Develop supplier performance metrics and drive supplier quality improvements.
Supplier Auditing & Compliance
  • Develop, prioritize, and execute supplier audit schedules based on risk and business needs.
  • Conduct supplier audits to assess compliance with:
    • GMP requirements
    • ISO 13485
    • FDA Quality System Regulations
    • Internal quality requirements
  • Identify audit findings and work with suppliers to implement corrective actions.
  • Verify effectiveness of supplier corrective actions and closure activities.
  • Monitor supplier compliance and quality performance trends.
Supplier Issue Resolution
  • Investigate supplier-related quality issues and nonconformances.
  • Lead root cause investigations using structured problem-solving methodologies.
  • Partner with suppliers to develop and implement corrective and preventive actions (CAPA).
  • Escalate critical supplier quality risks when necessary.
  • Support containment activities and material disposition decisions.
Pre-Market Supplier Quality Support (New Product Development)
  • Provide Supplier Quality Engineering support throughout the New Product Development (NPD) lifecycle.
  • Collaborate with Component Engineering, Design Engineering, Manufacturing Engineering, and Post-Market Supplier Quality teams.
  • Support supplier selection and qualification for new products.
  • Ensure purchased materials and components meet design, regulatory, and customer requirements.
  • Participate in design reviews and risk assessments.
  • Drive defect prevention and proactive quality planning activities.
Product Acceptance & Inspection Strategy
  • Collaborate with engineering teams to develop:
    • Product Acceptance Sampling Plans
    • Receiving Inspection Strategies
    • Control Plans
    • Inspection Requirements
  • Define incoming inspection methodologies and acceptance criteria.
  • Support risk-based inspection reduction initiatives where applicable.
  • Develop and validate inspection and test methods.
Risk Management & Quality Planning
  • Participate in supplier risk assessments and mitigation planning.
  • Support PFMEA and supplier-related risk management activities.
  • Evaluate quality risks associated with new suppliers, materials, and manufacturing processes.
  • Implement preventive quality strategies to reduce supplier-related defects.
Continuous Improvement
  • Analyze supplier quality data and identify trends.
  • Lead continuous improvement projects focused on:
    • Defect reduction
    • Process capability improvement
    • Cost reduction
    • Supplier performance enhancement
  • Recommend process, system, and product improvements.
Project Leadership & Technical Expertise
  • Independently manage supplier quality projects and initiatives.
  • Provide technical leadership on complex supplier quality challenges.
  • Mentor junior engineers and quality professionals.
  • Support cross-functional project teams in achieving program milestones.
  • Influence supplier and internal stakeholder decisions through technical expertise and data-driven recommendations.
Required Qualifications Education
  • Bachelor’s Degree in:
    • Engineering
    • Mechanical Engineering
    • Biomedical Engineering
    • Industrial Engineering
    • Manufacturing Engineering
    • Quality Engineering
    • Related technical discipline
Experience
  • Minimum 4 years of relevant Supplier Quality, Quality Engineering, Manufacturing Quality, or Product Quality experience.
  • OR Advanced Degree with minimum 2 years of relevant experience.
  • Experience within a regulated industry such as:
    • Medical Devices
    • Biotechnology
    • Pharmaceuticals
    • Diagnostics
    • Aerospace
    • Automotive

About the Company

L

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2000
WEBSITE
http://www.lancesoft.com/

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