Senior Quality Engineer — CAPA & Process Excellence

Michael Page; Dartmouth (MA); On-site; USD 110,000 - 140,000; Full time

Job summary

Michael Page is seeking a Senior Quality Engineer to lead complex investigations and drive CAPA initiatives in a regulated manufacturing environment. The role partners with operations, engineering, suppliers, and customers to ensure compliance and continuous quality improvements.

Ideal candidates have 5+ years of quality engineering experience, strong data-analysis skills, and a background in ISO13485/AS9100 contexts.

Qualifications

• Lead investigations into product non-conformances and customer quality issues.
• Drive CAPA activities from identification through implementation and verification.
• Analyse quality metrics, scrap rates, yield, and defects to identify trends and actions.
• Collaborate with engineering and operations to improve process capability and first-pass yield.
• Act as primary quality representative for audits and customer inquiries.
• Lead validation activities for processes and equipment (IQ/OQ/PQ).

Responsibilities

• Lead investigations into product non-conformances and customer concerns.
• Drive CAPA from identification to effectiveness verification.
• Analyse metrics to identify trends and corrective actions.
• Collaborate with engineering/operations to improve process capability.
• Oversee quality system processes including MRB, non-conformance, and audits.
• Lead validation activities and PFMEA/risk assessments.

Skills

Communication

Problem solving

Data analysis

Influence stakeholders

Quality mindset

Education

Bachelor’s degree in Mechanical Engineering, Electrical Engineering, or Chemical Engineering

Tools

Minitab

Job description

Michael Page is seeking a Senior Quality Engineer to lead complex investigations and drive CAPA initiatives in a regulated manufacturing environment. The role partners with operations, engineering, suppliers, and customers to ensure compliance and continuous quality improvements.

Ideal candidates have 5+ years of quality engineering experience, strong data-analysis skills, and a background in ISO13485/AS9100 contexts.