Senior Quality Engineer
Michael Page · New Bedford, MA · 3 days ago
Engineering$115k–$130k/yrFull-time
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.Client DetailsOur 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 environmentExperience supporting aerospace, medical device, or other highly regulated industries preferredStrong knowledge of CAPA, MRB, NCMR, and quality management systemsExperience with root cause analysis methodologies such as 8D, DMAIC, or similarProficiency with statistical analysis tools including SPC, DOE, capability studies, and MinitabExperience leading process validation activities (IQ/OQ/PQ)Familiarity with AS9100 and/or ISO 13485 standardsASQ Certified Quality Engineer (CQE) certification preferredStrong communication skills with customers and cross-functional stakeholdersAbility to independently drive investigations and implement solutionsMust meet ITAR/EAR eligibility requirements Job OfferCompetitive 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 operationsHigh-visibility position with direct customer interaction and leadership exposureLead meaningful continuous improvement projects that impact operational performanceWork within a highly regulated environment utilizing advanced quality methodologiesStrong 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.