Quality Engineer – Medical Devices & CAPA Lead

ExcelliSearch, Inc.; Sault Ste. Marie (MI); Vor Ort; USD 90.000 - 100.000; Vollzeit

Benefits dieser Stelle

Health, Dental and Vision Insurance (H

401k Match

PTO

Relocation Lump Sum

Zusammenfassung

ExcelliSearch, Inc. is seeking a Quality Engineer in Sault Ste. Marie, Michigan to join a growing medical device manufacturing team.

The role focuses on ensuring product quality, process capability, and regulatory compliance in a highly controlled environment. The successful candidate will develop and maintain quality systems, lead continuous improvement initiatives, and collaborate with manufacturing, engineering, suppliers, and customers to sustain high product quality and drive CAPA, PFMEA,

Qualifikationen

• Bachelor’s degree in engineering is required.
• 3+ years of quality engineering experience in a manufacturing environment.
• Experience working with internal and external customers.
• Experience using multiple types of precision measuring equipment.
• Familiarity with Six Sigma, SPC, Lean Manufacturing, PFMEA and control plans.

Aufgaben

• Support quality activities across manufacturing operations.
• Develop and maintain inspection plans for new and existing products.
• Participate in MRB and New Product Release Reviews.
• Lead CAPA activities and corrective actions.
• Support and facilitate process and product validation.
• Develop PFMEA and Control Plans and maintain SPC programs.
• Conduct process capability studies and Gage R&R analyses.
• Collaborate with suppliers and customers to standardize inspection methods.

Kenntnisse

Quality engineering

Six Sigma

SPC

Lean Manufacturing

Ausbildung

Bachelor’s Degree in Engineering

Tools

PFMEA

Control Plans

Gage R&R

Jobbeschreibung

ExcelliSearch, Inc. is seeking a Quality Engineer in Sault Ste. Marie, Michigan to join a growing medical device manufacturing team.

The role focuses on ensuring product quality, process capability, and regulatory compliance in a highly controlled environment. The successful candidate will develop and maintain quality systems, lead continuous improvement initiatives, and collaborate with manufacturing, engineering, suppliers, and customers to sustain high product quality and drive CAPA, PFMEA,