Supplier Quality Engineer

Responsibilities

• Collaborate with suppliers through meetings, audits, and reviews to identify risks, drive corrective actions, and improve quality outcomes.
• Plan and lead supplier audits to maintain compliance with applicable standards.
• Lead First Article Inspection and/or Component Qualifications.
• Investigate and resolve supplier-related non-conformance material reports (NCMRs) that impact product quality, manufacturing, or business performance.
• Drive improvement and corrective action (SCARs) for components sourced from suppliers.
• Analyze incoming material defects and communicate issues to suppliers.
• Develop, maintain, and improve receiving inspection and process documentation to ensure consistency and compliance.
• Generate and maintain incoming inspection procedures.
• Absorb and complete supplier assessments and evaluations.
• Evaluate and support supplier changes for potential effects on design, quality, and regulatory compliance for manufacturing and development projects.
• Participate in risk management activities such as FMEA development and updates.
• Track purchased item requirements back to design requirements.
• Evaluate and facilitate supplier process validation.

Requirements

• 4+ years of experience in supplier quality, specifically in a medical device environment (ISO13485).
• Extensive expertise in supplier management and quality systems.
• Experience in vendor management, supplier relationship, and performance.
• Understanding of ISO and FDA QSR requirements including design controls, risk management, and process validation.
• Proficiency in eQMS systems, preferably GAS.
• Ability to conduct Root Cause Analysis (RCA) and draw valid conclusions.
• Highly proficient with MS Office (Word, Excel, Access, and PowerPoint), internet, and email systems.
• Ability to interpret and understand drawing specifications, tolerances, procedures for inspection, and application of sampling plans.

Essential Skills

• 4+ years of experience in supplier quality, specifically in a medical device environment (ISO13485).
• Extensive expertise in supplier management and quality systems.
• Experience in vendor management, supplier relationship, and performance.
• Understanding of ISO and FDA QSR requirements including design controls, risk management, and process validation.
• Proficiency in eQMS systems, preferably GAS.
• Ability to conduct Root Cause Analysis (RCA) and draw valid conclusions.
• Highly proficient with MS Office (Word, Excel, Access, and PowerPoint), internet, and email systems.
• Ability to interpret and understand drawing specifications, tolerances, procedures for inspection, and application of sampling plans.

Additional Skills & Qualifications

• Auditor certification and experience conducting supplier audits.
• Automated inspection programming and validation (preferred).
• Solid understanding of software capabilities and business applications.
• Familiarity with inspection devices such as pin gauges, micrometers, calipers, pressure gauges, rules, and microscopes.
• Broad knowledge of theory and principles of statistics.
• Ability to accurately prioritize and execute tasks with minimal direction.

Pay And Benefits

The pay range for this position is $95,000.00 - $101,000.00/yr.

Standard Benefits:

• 401K
• Health, dental, vision
• In house gym
• HSA options
• Yearly bonuses based on company/individual performance
• Three weeks PTO (+ week between Christmas and New Years off)

Workplace Type

This is a fully onsite position in Minneapolis, MN.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

San Francisco Fair Chance Ordinance

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.