Senior Design Quality Engineer, Medical Devices (Lead)

STSI (Staffing Technical Services Inc.); Ohio; On-site; USD 118,000 - 140,000; Full time

Benefits offered by this job

Comprehensive Client Benefit Package

Job summary

STSI in Greenville, OH is seeking a Senior Design Project Engineer, Quality to lead quality initiatives in the design and manufacturing of medical devices and components.

The role requires a Bachelor's degree in engineering and 6+ years of relevant experience; CQE and Six Sigma Black Belt/CRE are preferred. You will drive QMS activities, audits, and cross-functional collaboration to ensure regulatory compliance.

Qualifications

• Bachelor's degree in engineering or related field.
• 6+ years of relevant experience or equivalent combination.
• CQE preferred.
• Six Sigma Black Belt and CRE certifications preferred.
• Experience in the medical device industry and understanding of quality systems is desired.
• Ability to influence and negotiate with all levels and lead change initiatives.
• Ability to design complex, interconnected systems or processes.

Responsibilities

• Maintain and improve the Quality Management System (QMS) for regulatory compliance.
• Drive product quality improvements with design, manufacturing, and supply chain.
• Provide technical leadership and risk mitigation for critical systems.
• Formulate solutions to complex, ill-defined problems.
• Communicate technical ideas through presentations and workshops.
• Collaborate across teams to align decisions with goals.
• Ensure compliance with FDA, ISO, UL, CSA and other agencies.
• Lead Six Sigma initiatives and standardization efforts.
• Identify and manage Six Sigma projects with internal and supplier teams.
• Mentor and coach engineers at multiple levels.
• Support or lead internal and external QMS audits and investigations.

Education

Bachelor's degree in engineering or related field

6+ years of relevant experience

CQE

Six Sigma Black Belt

Certified Reliability Engineer (CRE)

Influence and negotiation

Lead complex systems design

Job description

STSI in Greenville, OH is seeking a Senior Design Project Engineer, Quality to lead quality initiatives in the design and manufacturing of medical devices and components.

The role requires a Bachelor's degree in engineering and 6+ years of relevant experience; CQE and Six Sigma Black Belt/CRE are preferred. You will drive QMS activities, audits, and cross-functional collaboration to ensure regulatory compliance.