Medical Engineering Consultants (MEC) ยท 9 hours ago
Supplier Quality Engineer
Brooklyn Park, MN
Contract
Onsite
Senior Level
7+ years expMedical Engineering Consultants (MEC) supports medical device and pharmaceutical companies by providing resources and expertise to improve efficiency. The Supplier Quality Engineer collaborates with various teams to investigate component nonconformances, implement corrective actions, and ensure compliance with FDA and ISO standards.
ConsultingMedical DevicePharmaceuticalTraining
No H1B
Responsibilities
Investigate and resolve supplier-related NCMRs that impact product quality, manufacturing, or business performance
Drive improvement and corrective action (SCARs) for components sourced from suppliers
Analyzes incoming material defects and communicates issues to suppliers
Develop, maintain, and improve receiving inspection and process documentation to ensure consistency and compliance Generates and maintains incoming inspection procedures
Assists in generating component specifications
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
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
Qualification
Required
Extensive expertise in supplier management and quality systems in a medical device environment
ISO 13485 Lead Auditor certification
Experience conducting supplier audits
Understanding of ISO 13485 and FDA QSR requirements including design controls, risk management, and process validation
Experience in eQMS systems, preferably GAS
Root Cause Analysis (RCA) including, ability to define problems, collect data, establish facts and draw valid conclusions
Highly proficient with MS Office (Word, Excel, Access and PowerPoint), internet and e-mail systems
Solid understanding of software capabilities and business applications
Ability to accurately prioritize and execute with minimal direction
Ability to interpret and understand drawing specifications, tolerances, procedures for inspection and the application of sampling plans
Familiar with the ability to use inspection devices such as pin gauges, micrometers, calipers, pressure gauges, rules and microscopes
Broad knowledge of theory and principles of statistics and statistical process control
Excellent communication skills (written and verbal)
Strong interpersonal communication skills with the ability to effectively communicate with suppliers
Creative problem solver coupled with good judgment
Independent work skills
High attention to detail and accuracy
Ability to manage, prioritize and execute multiple tasks
Positive, flexible outlook
Bachelor Degree in engineering or a related STEM field is preferred. Equivalent work experience or MBA may substitute
Minimum of 7+ years experience in Supplier Quality Engineering in a medical device manufacturing/process development environment
Experience in planning and leading supplier audits
Experience in a manufacturing team environment
Preferred
Catheter assembly preferred
Company
Medical Engineering Consultants (MEC)
MEC is a comprehensive solution provider with a full suite of services from consulting and contracting to training and cost savings initiatives.
Founded in 2011Fort Lauderdale, Florida, USA
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Christopher Gustine
Managing Partner
David Campo
Managing Partner
Company data provided by crunchbase