Quality Engineer – Medical Devices, CAPA & SPC Lead

Horan Hiring Solutions, LLC; Sault Ste. Marie (MI); On-site; USD 90,000 - 100,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance (L

401k Match

PTO

Relocation Lump Sum

and much more

Job summary

Horan Hiring Solutions, LLC is seeking a Quality Engineer for a medical device manufacturer in Sault Ste. Marie, Michigan.

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

Qualifications

• Bachelor’s Degree in Engineering is required.
• 3+ years of experience in quality engineering within a manufacturing environment.
• Experience with internal and external customers.
• Experience using multiple types of precision measuring equipment.

Responsibilities

• 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 initiatives.
• Support validation activities for processes and products.
• Develop PFMEA and Control Plans.
• Conduct process capability and SPC analyses.
• Maintain SPC programs and Gage R&R.
• Evaluate and improve inspection methods and quality procedures.
• Program and support inspection equipment.
• Conduct vendor audits and supplier quality activities.
• Support internal and external customer audits.
• Develop and update work instructions and quality documentation.
• Train employees on quality procedures and inspection standards.
• Collaborate with suppliers and customers to standardize inspection processes.

Skills

Six Sigma

SPC

Lean Manufacturing

PFMEA & Control Plans

Process improvement

Education

Bachelor’s Degree in Engineering

Job description

Horan Hiring Solutions, LLC is seeking a Quality Engineer for a medical device manufacturer in Sault Ste. Marie, Michigan.

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