Senior Quality Engineer

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

We're seeking a Senior Quality Engineer to take ownership of product and process quality across a highly regulated manufacturing environment. This position combines technical leadership, customer engagement, root cause investigations, and continuous improvement initiatives to drive operational excellence and product reliability.

Our client is a global advanced manufacturing organization known for developing highly engineered products used in mission-critical applications. With a strong focus on innovation, quality, and continuous improvement, the company offers the opportunity to work on complex challenges that directly impact customers across demanding industries.

Description

Product & Process Quality Leadership

• Lead investigations into nonconforming product, quality escapes, customer complaints, and manufacturing issues.
• Utilize structured problem-solving tools such as 8D, DMAIC, and Root Cause Analysis to identify and eliminate recurring issues.
• Drive Corrective and Preventive Actions (CAPA) from initiation through effectiveness verification.
• Analyze quality metrics including scrap, yield, defects, and process performance to identify trends and improvement opportunities.
• Collaborate with Manufacturing and Engineering teams to improve process capability, reduce variation, and increase first-pass yield.

Customer & Regulatory Quality

• Serve as the primary quality representative for customer concerns, SCAR responses, audits, and technical discussions.
• Interface directly with customers to resolve quality issues and maintain strong relationships.
• Support customer visits, audits, and quality reviews.
• Ensure compliance with AS9100, ISO 13485, and customer-specific quality requirements.

Quality Systems & Compliance

• Maintain and improve key quality system processes including CAPA, MRB, NCMR, and RMA.
• Support internal, customer, and third‑party audits from preparation through corrective action implementation.
• Develop and enhance quality documentation including PFMEAs, Control Plans, inspection plans, and process controls.
• Drive quality system improvements to ensure regulatory and customer compliance.

Validation & Risk Management

• Lead validation activities including IQ, OQ, and PQ for manufacturing processes and equipment.
• Conduct risk assessments and develop mitigation strategies through PFMEA and process controls.
• Implement effective monitoring and control plans to sustain product quality.

Data Analytics & Continuous Improvement

• Utilize SPC, DOE, capability studies, and statistical analysis tools to support decision-making.
• Develop quality dashboards and performance reports for leadership visibility.
• Lead projects focused on scrap reduction, yield improvement, variation reduction, and process stability.

Supplier Quality & Inspection

• Support supplier quality initiatives, issue resolution, and supplier performance improvement.
• Improve measurement systems through MSA, GR&R studies, and calibration programs.
• Provide expertise on inspection methods, metrology, and gauging strategies.

Technical Leadership

• Mentor quality engineers and cross‑functional team members.
• Lead cross‑functional teams in solving complex manufacturing and customer quality challenges.
• Influence quality‑driven decision‑making across the organization without direct authority.

Profile

Requirements to Apply

• Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, Manufacturing, or related discipline)
• 5+ years of Quality Engineering experience within a manufacturing environment
• Experience supporting aerospace, medical device, or other highly regulated industries preferred
• Strong knowledge of CAPA, MRB, NCMR, and quality management systems
• Experience with root cause analysis methodologies such as 8D, DMAIC, or similar
• Proficiency with statistical analysis tools including SPC, DOE, capability studies, and Minitab
• Experience leading process validation activities (IQ/OQ/PQ)
• Familiarity with AS9100 and/or ISO 13485 standards
• ASQ Certified Quality Engineer (CQE) certification preferred
• Strong communication skills with customers and cross‑functional stakeholders
• Ability to independently drive investigations and implement solutions
• Must meet ITAR/EAR eligibility requirements

Job Offer

• Competitive salary ranging from $115,000 to $130,000 annually.
• Permanent position with growth potential.
• Bonus potential
• Opportunity to influence quality strategy across aerospace and medical manufacturing operations
• High‑visibility position with direct customer interaction and leadership exposure
• Lead meaningful continuous improvement projects that impact operational performance
• Work within a highly regulated environment utilizing advanced quality methodologies
• Strong opportunity for professional growth, technical leadership, and career advancement

Desired Skills and Experience

• 5+ years of Quality Engineering experience within a manufacturing environment
• Experience supporting aerospace, medical device, or other highly regulated industries preferred
• Strong knowledge of CAPA, MRB, NCMR, and quality management systems
• Experience with root cause analysis methodologies such as 8D, DMAIC, or similar
• Proficiency with statistical analysis tools including SPC, DOE, capability studies, and Minitab
• Experience leading process validation activities (IQ/OQ/PQ)
• Familiarity with AS9100 and/or ISO 13485 standards

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.