Quality Engineer

Horan Hiring Solutions, LLC; Sault Ste. Marie (MI); Vor Ort; USD 90.000 - 100.000; Vollzeit

Benefits dieser Stelle

Health, Dental and Vision Insurance (L

401k Match

PTO

Relocation Lump Sum

and much more

Zusammenfassung

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

Qualifikationen

• 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.

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 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.

Kenntnisse

Six Sigma

SPC

Lean Manufacturing

PFMEA & Control Plans

Process improvement

Ausbildung

Bachelor’s Degree in Engineering

Jobbeschreibung

Quality Engineer

Medical Manufacturing

Sault Ste Marie, Michigan

$90-100k

A growing medical device manufacturer backed by a global industrial organization and is seeking a Quality Engineer to join its team. The company produces high-precision surgical products within a highly regulated manufacturing environment.

This role plays a critical part in ensuring product quality, process capability, and compliance with industry standards. The ideal candidate will have strong analytical abilities, attention to detail, and experience supporting manufacturing quality systems.

Position Overview

The Quality Engineer will support manufacturing operations by developing and maintaining quality systems, leading process improvement initiatives, and ensuring compliance with regulatory standards. This individual will work closely with manufacturing, engineering, suppliers, and customers to maintain high product quality and drive continuous improvement.

Key Responsibilities

• Support quality activities across manufacturing operations
• Develop and maintain inspection plans for new and existing products
• Participate in Material Review Board (MRB) and New Product Release Reviews
• Lead corrective and preventive actions (CAPA)
• Support and facilitate process and product validation activities
• Develop and maintain PFMEA and Control Plans
• Conduct process capability and statistical analysis
• Develop and maintain Statistical Process Control (SPC) programs
• Perform Gage R&R and Measurement System Analysis
• 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

Qualifications

Education

• Bachelor’s Degree in Engineering required

Experience

• 3+ years of experience in quality engineering within a manufacturing environment preferred
• Experience working with internal and external customers
• Experience using multiple types of precision measuring equipment

Technical Knowledge

• Preferred experience with:
• Six Sigma methodologies
• Statistical Process Control (SPC)
• Lean Manufacturing
• PFMEA and Control Plans

Benefits

• Base: $85-95k
• Health, Dental and Vision Insurance (BCBS)
• 401k Match
• PTO
• Relocation Lump Sum
• and much more

This is a great opportunity with a great company.