Senior Quality Engineer, Regulated Manufacturing

Michael Page; New Bedford (MA); On-site; USD 115,000 - 130,000; Full time

Benefits offered by this job

Bonus potential

Job summary

Michael Page seeks a Senior Quality Engineer to own product and process quality in a highly regulated manufacturing environment. Lead investigations, drive CAPA, and collaborate with manufacturing and engineering to improve process capability and yield.

You will interface with customers, support audits, and ensure compliance with AS9100/ISO13485 standards while mentoring junior team members and influencing quality decisions across the organization.

Qualifications

• Bachelor's degree in Engineering required.
• 5+ years in Quality Engineering in a manufacturing environment.
• Experience with aerospace/medical device or other highly regulated industries preferred.
• Strong knowledge of CAPA, MRB, NCMR, and quality management systems.

Responsibilities

• Lead investigations into nonconforming product, escapes, customer complaints, and manufacturing issues.
• Utilize 8D, DMAIC, and Root Cause Analysis to identify and eliminate recurring problems.
• Drive CAPA from initiation through effectiveness verification.
• Analyze scrap, yield, defects, and process performance to identify trends.
• Collaborate with Manufacturing and Engineering to improve process capability and first-pass yield.
• Serve as quality representative for customer concerns, audits, and technical discussions.

Skills

CAPA

MRB

NCMR

Quality mgmt systems

Root cause analysis

8D/DMAIC

SPC/DOE

Minitab

AS9100/ISO13485 familiarity

Customer communication

Education

Bachelor's degree in Engineering

Tools

Minitab

MS Excel

Job description

Michael Page seeks a Senior Quality Engineer to own product and process quality in a highly regulated manufacturing environment. Lead investigations, drive CAPA, and collaborate with manufacturing and engineering to improve process capability and yield.

You will interface with customers, support audits, and ensure compliance with AS9100/ISO13485 standards while mentoring junior team members and influencing quality decisions across the organization.