Supplier Quality Engineer

***C2C is unavailable for this role. Will be on W2***

Pay: $40 - 45/HR

Contract Length - 1 YEAR FROM START DATE (EXTENSIONS AVAILABLE BASED ON PERFORMANCE AND BUDGET)

Position Overview:

We are seeking a Supplier Quality Engineer (SQE) to support our new product development and production quality initiatives. This role will focus on supplier engagement, material qualification, and issue resolution, requiring a hands-on approach rather than a documentation-heavy role.

The ideal candidate will have medical device experience and must be comfortable working directly with suppliers to qualify materials, validate processes, and ensure compliance with specifications.

Key Responsibilities:

New Product Development & Supplier Qualification:

• Collaborate with R&D and Quality Operations teams to qualify specifications.
• Engage with suppliers to qualify new materials, ensuring compliance with control plans.
• Review and interpret technical specifications and drive supplier validation activities.
• Ensure seamless integration of new materials into the production process.

Production Support & CAPA Investigations:

• Conduct root cause analyses and CAPA investigations related to supplier issues.
• Document findings and work closely with vendors to implement corrective actions.
• Ensure supplier-provided materials meet regulatory and quality standards.

Supplier Engagement & Process Validation:

• Lead supplier process validation and incoming inspection of new materials.
• Maintain strong communication with vendors to relay expectations and drive material qualifications.
• Support quality and regulatory teams in supplier assessments and compliance initiatives.

Preferred Qualifications:

• Process validation experience to qualify supplier materials.
• Strong communication skills, especially with suppliers.
• CAPA investigation experience in a manufacturing setting.
• Medical device industry experience
• Comfortable working directly with suppliers to troubleshoot and validate materials.
• Ability to lead supplier discussions and drive material qualifications independently.
• Background in quality & manufacturing or quality & regulatory functions.
• Certified Quality Engineer (CQE) preferred.

Top Skills & Deal Breakers:

• Ability to read and interpret specifications and independently qualify materials.
• Experience in process/product development or supplier validation.
• Strong problem-solving skills with a track record of CAPA investigations & improvements.

Experience & Education:

• 1–3 years working in supplier quality.
• Bachelor’s degree in Engineering (preferred).
• CQE certification (preferred but not required).

Work Environment & Additional Info:

• Onsite from Day 1 (candidates must relocate at their own expense if necessary).
• Regular interaction with R&D, Quality Engineering, and Supplier Teams.
• Daily tasks include reviewing specifications, supplier process validation, and vendor calls.

Interview Process:

• Round 1: 40-minute video call with hiring manager.
• Round 2: Three 30-minute interviews with R&D Manager, QE Manager, and hiring manager.