Supplier Quality Engineer, Engineer I)

Supplier Quality Engineer

Key Responsibilities

• Develop component inspection methods and inspection plans, including test method validation and component capability assessments.
• Support supplier process validation and component qualification activities for new medical device products.
• Review engineering drawings, blueprints, and technical specifications to ensure quality and reliability standards are met.
• Support drawing reviews to ensure Design for Excellence (DFX) and inspection considerations are incorporated into product designs.
• Prepare and manage component qualification documentation and approval processes.
• Perform receiving inspections and component inspections for engineering milestone builds.
• Investigate non-conformances and support risk-based escalation and resolution activities.
• Support the transfer of receiving inspection processes to other manufacturing and supplier locations.
• Collaborate with engineering, manufacturing, and supplier teams to support new product development and product launches.

Requirements & Tech Stack

• Bachelor's degree in Engineering.
• 0–2 years of relevant engineering or quality experience.
• Knowledge of engineering drawings, blueprints, schematics, and technical specifications.
• Strong analytical, problem-solving, and communication skills.
• Ability to interpret technical documentation and engineering specifications.
• Familiarity with CAD software and engineering applications.

Preferred Qualifications:

• Exposure to Supplier Quality Engineering or Supplier Qualification.
• Knowledge of PPAP and component qualification.
• Experience with receiving inspection, component inspection, or manufacturing quality.
• Familiarity with test method validation and process validation.
• Medical device or regulated manufacturing industry experience is a plus.