Supplier Quality Engineer II

Switchback Medical -
Brooklyn Park, MN

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Job Details

Full-time
$95,000 - $105,000 a year

Qualifications

Manufacturing facility experience
Medical device manufacturing facility experience

Full Job Description

Summary:

The Supplier Quality Engineer collaborates with suppliers, manufacturing, development, and supply chain teams to ensure suppliers are qualified and deliver high quality components. This will include supplier monitoring, investigating supplied component nonconformances, implement corrective actions, and driving continuous improvement. Additional responsibilities include conducting supplier assessments and audits, maintaining compliant documentation, and ensuring adherence to FDA 21 CFR Part 820 and ISO 13485 standards.

Key Responsibilities (but are not limited to):

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 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.
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.
Tracing purchased item requirements back to design requirements.
Evaluate and facilitate supplier process validation.

Technical Skills:

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.
Automated inspection programming and validation (preferred).
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).

Conceptual Skills:

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.

Education/Experience:

Bachelor Degree in engineering or a related STEM field is preferred. Equivalent work experience or MBA may substitute.
Minimum of 5+ 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. Catheter assembly preferred.

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