Quality Engineer II — CQE-Driven Process & Compliance

Coghlin Companies Inc; West Boylston (MA); On-site; USD 85,000 - 110,000; Full time

Job summary

Cogmedix in West Boylston, MA seeks an experienced quality leader to drive compliance across electro-mechanical manufacturing. You will mentor teams, lead process improvements, and ensure all outgoing products meet regulatory standards.

The role emphasizes root cause analysis, CAPA implementation, and cross-functional collaboration with engineering, supply chain and operations. A Bachelor’s in science or engineering and 7+ years in manufacturing are preferred.

Qualifications

• Bachelor’s degree, preferably in a science or engineering discipline; significant and applicable professional experience may be considered in lieu of certain educational requirements.
• Minimum of 7 years professional experience in electro-mechanical manufacturing field preferred.
• Experience in ISO 9001 requirements is preferred.
• Strong electro-mechanical orientation.
• Knowledge of IPC 610 and 620 standards beneficial.
• Six Sigma trained/certified or knowledge of statistical analysis methods and techniques.

Responsibilities

• Lead by example and promote strict compliance at Columbia Tech.
• Train personnel on workmanship and quality standards.
• Provide guidance and oversight to multiple teams, including mentorship.
• Develop and implement improvements and processes, becoming a quality expert.
• Ensure outgoing product is manufactured in a compliant manner.
• Support process qualification/validation and new product introduction processes.
• Develop and execute Quality Plans for customer accounts.
• Review device history records for quality approval.
• Drive root cause analysis and implement corrective actions.
• Support supplier quality with non-conforming material issues resolution.
• Collaborate with cross-functional teams to determine root causes of customer issues.
• Assist in regulatory audit for customer accounts.
• Maintain strong data collection, metrics and presentations for customers.

Skills

Positive attitude

Customer service oriented

Teamwork & communication

Six Sigma knowledge

Education

Bachelor’s degree in science or engineering

Tools

MS Word

MS Excel

MS Visio

Job description

Cogmedix in West Boylston, MA seeks an experienced quality leader to drive compliance across electro-mechanical manufacturing. You will mentor teams, lead process improvements, and ensure all outgoing products meet regulatory standards.

The role emphasizes root cause analysis, CAPA implementation, and cross-functional collaboration with engineering, supply chain and operations. A Bachelor’s in science or engineering and 7+ years in manufacturing are preferred.