Senior Medical Device Design & Quality Engineer

Regulatory Jobs; Ohio; Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

Regulatory Jobs seeks a seasoned quality leader to oversee regulatory compliance across medical devices. You will drive the QMS and collaborate with R+D, manufacturing, service, and supply chain to ensure quality, compliance and cost targets.

Leading Six Sigma initiatives, you will mentor engineers and guide audits, while aligning decisions with company goals. Prior CQE/CRE certifications and 6+ years in medical device quality are preferred.

Qualifications

• Bachelor’s degree in engineering or related field required; 6+ years of relevant experience.
• CQE, Six Sigma Black Belt and CRE certifications preferred.
• Experience in the medical device quality systems and regulatory requirements.

Responsabilités

• Lead cross-functional teams to ensure regulatory compliance of medical devices.
• Develop and improve the Quality Management System (QMS).
• Drive Six Sigma projects and continual process improvement.
• Mentor engineers and support internal/external audits.

Connaissances

Regulatory knowledge

Influencing others

Quality systems

Problem solving

Technical leadership

Formation

Bachelor's degree in engineering or related field

Certified Quality Engineer (CQE)

Six Sigma Black Belt

Certified Reliability Engineer (CRE)

Description du poste

Regulatory Jobs seeks a seasoned quality leader to oversee regulatory compliance across medical devices. You will drive the QMS and collaborate with R+D, manufacturing, service, and supply chain to ensure quality, compliance and cost targets.

Leading Six Sigma initiatives, you will mentor engineers and guide audits, while aligning decisions with company goals. Prior CQE/CRE certifications and 6+ years in medical device quality are preferred.