Senior Quality Engineer II - ISO 9001 | CQE Preferred

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

Job summary

Cogmedix is seeking a Quality Engineer with a strong electro-mechanical manufacturing background to lead quality initiatives and ensure compliant production.

You will develop quality plans, review device history records, and drive CAPA through root cause analysis. Collaboration across engineering, manufacturing, and supply chain is essential to improve processes and prevent non-conformances.

Qualifications

• Bachelor’s degree in science or engineering or equivalent experience.
• 7+ years in electro-mechanical manufacturing environment.
• Experience with ISO 9001 requirements preferred.
• CQE certification preferred.

Responsibilities

• Lead in promoting strict compliance and quality adherence.
• Develop and implement quality plans for customer accounts.
• Review device history records for quality approval.
• Drive and implement corrective and preventive actions (CAPA).
• Support process qualification/validation and new product introductions.
• Collaborate with cross-functional teams to resolve customer issues and improve quality.

Skills

Six Sigma

Root cause analysis

ISO 9001

IPC 610/620

CQE

Quality systems

MRB process

Quality planning

MS Excel (macros)

MS Visio

MS Word

Education

Bachelor’s degree in science or engineering

Tools

Visio

Excel

Word

Job description

Cogmedix is seeking a Quality Engineer with a strong electro-mechanical manufacturing background to lead quality initiatives and ensure compliant production.

You will develop quality plans, review device history records, and drive CAPA through root cause analysis. Collaboration across engineering, manufacturing, and supply chain is essential to improve processes and prevent non-conformances.