Quality Engineer, Medical Devices — Process & Compliance

Energy Jobline ZR; City of Rochester (NY); Sur place; USD 75 000 - 95 000; Plein temps

Avantages offerts par ce poste

401(k)

401(k) matching

Dental Insurance

Health insurance

Health savings account

Life insurance

Paid time off

Tuition reimbursement

Vision insurance

Résumé du poste

Röchling Medical Rochester is seeking a seasoned Quality Engineer to lead quality engineering activities ensuring products, processes and QMS compliance. You will guide development and validation, drive continuous improvement, and partner across functions to raise product quality and manufacturing performance.

Ideal candidates bring 5+ years in quality engineering within regulated manufacturing, CQE certification, and Lean Six Sigma expertise, with strong communication, auditing, and

Qualifications

• BS degree in engineering, quality, manufacturing, or related technical field.
• 5 years of quality engineering experience in a regulated environment.
• CQE certification and Lean Six Sigma green/black belt preferred.

Responsabilités

• Lead quality engineering activities ensuring regulatory, customer and company requirements are met.
• Support development and validation activities including IQ/OQ/PQ and software validation.
• Develop and maintain control plans, PFMEA, and risk documentation.
• Conduct audits and supplier qualifications; act as SME during external audits.
• Monitor quality performance, analyze data, and present metrics for continuous improvement.
• Investigate nonconformities, CAPAs, root-cause analysis and problem solving.
• Collaborate cross-functionally to improve product quality and manufacturing performance.

Connaissances

Quality leadership

FDA 21 CFR Part 820

ISO 13485

Problem solving

Statistical analysis

Project management

Cross-functional collaboration

GD&T

Auditing

Vendor/audit experience

Formation

BS degree in Engineering, Quality, Manufacturing, or related technical discipline

ASQ Certified Quality Engineer (CQE)

Lean Six Sigma Green Belt or Black Belt

Outils

Minitab

Description du poste

Röchling Medical Rochester is seeking a seasoned Quality Engineer to lead quality engineering activities ensuring products, processes and QMS compliance. You will guide development and validation, drive continuous improvement, and partner across functions to raise product quality and manufacturing performance.

Ideal candidates bring 5+ years in quality engineering within regulated manufacturing, CQE certification, and Lean Six Sigma expertise, with strong communication, auditing, and