Quality Engineer III

Producto
  • Shirley, MA
    2 days ago

    Job Description

    The Quality Engineer III is a senior role that leads quality engineering for complex products, key customers, and critical processes from new product launch through ongoing production. This role sets the quality strategy for assigned programs, leads high-risk investigations and validations, and makes final quality decisions on nonconforming material and product release. The Quality Engineer III serves as the lead quality contact for key customers and suppliers, mentors other quality engineers, and drives improvements to quality systems, methods, and tools. The ideal candidate is an expert, data-driven engineer with deep experience in aerospace, medical device, or other regulated manufacturing environments and a proven record of leading quality improvement.

     

    KEY RESPONSIBILITIES

    • Champion and uphold the company's values, mission, and quality policy in all activities.

    • Adhere to and help enforce company policies, procedures, and internal control standards.

    • Ensure compliance with all applicable Quality Management System (QMS) requirements, including ISO 9001, AS9100, and ISO 13485, as applicable to this role.

    • Follow all safety rules and PPE requirements, and promptly report hazards, incidents, and near-misses.

    • Lead quality planning for complex products and programs, and approve quality plans, inspection plans, and control plans.

    • Lead quality activities for new product introduction, including PFMEAs, process validation (IQ/OQ/PQ) strategy and approval, and production part approval as required.

    • Oversee first article inspection (FAI) requirements and approve FAI results in accordance with Quality Management System (QMS) and customer requirements.

    • Chair material review board (MRB) activities and make final disposition decisions on complex or high-risk nonconforming material.

    • Lead complex, high-risk root cause investigations (e.g., 8D, 5 Whys, fishbone) and oversee the CAPA system to ensure timely, effective closure.

    • Serve as the lead quality contact for key customers, managing escalations, quality requirements, and quality performance reviews.

    • Lead the supplier quality program, including supplier audits, qualification, SCARs, and supplier performance monitoring.

    • Establish SPC, process capability, and measurement system analysis (MSA/Gage R&R) standards, and lead advanced statistical analysis to improve process performance.

    • Set inspection strategy, methods, and equipment requirements, and oversee CMM programming standards and the gauge calibration program.

    • Lead the internal audit program and host customer and registrar audits, driving timely closure of findings.

    • Analyze quality metrics and cost of poor quality, present trends and recommendations to leadership, and lead improvement initiatives.

    • Mentor and provide technical guidance to inspection personnel and develop quality training programs.

    • Perform other related duties as assigned.

     

    EDUCATION & EXPERIENCE

    • Bachelor's degree in Mechanical, Manufacturing, Industrial, or Quality Engineering, or a related technical field, required.

    • 4–7 years of quality engineering experience in a regulated manufacturing environment (aerospace, medical device, automotive, or similar) required.

    • Proven experience leading first article inspection, nonconformance management, CAPA, and audits required.

    • ASQ Certified Quality Engineer (CQE) and/or Six Sigma Black Belt preferred; Certified Quality Auditor (CQA) a plus.

     

    SKILLS & QUALIFICATIONS

    • Expert blueprint reading skills, including advanced GD&T.

    • Advanced knowledge of statistical tools and software (e.g., Minitab) for SPC, capability, MSA, and design of experiments (DOE).

    • Expert in structured problem-solving and root cause analysis methods, with the ability to coach others.

    • Strong knowledge of inspection equipment and methods, including CMMs, height gauges, calipers, micrometers, and optical comparators.

    • Strong working knowledge of quality system requirements under ISO 9001, AS9100, and ISO 13485, as applicable to this role.

    • Excellent written, verbal, and presentation skills, with the ability to lead discussions with customers, suppliers, auditors, and leadership.

    • Proficiency with Microsoft Office, ERP systems, and electronic quality management software (Propel).

     

    TRAINING & COMPETENCY REQUIREMENTS

    • Complete new-hire orientation and role-specific on-the-job training prior to performing unsupervised work.

    • Complete Quality Management System (QMS) training applicable to this role, including quality policy awareness and the consequences of nonconformance to product or process requirements.

    • Complete safety training applicable to this role (e.g., PPE use, lockout/tagout, forklift certification).

    • Maintain competency through periodic refresher or retraining as required by department procedures and applicable regulatory requirements.

     

    WORK ENVIRONMENT

    • Office setting.

    • Manufacturing floor and inspection lab environments.

    • Use of personal protective equipment (PPE) such as safety glasses.

     

    PHYSICAL REQUIREMENTS

    • Prolonged periods sitting at a desk and working on a computer.

    • Regular standing and walking on the production floor and in the inspection area.

    • Ability to handle parts and inspection equipment.

     

    EXPECTED HOURS OF WORK

    • This is a full-time exempt position, required to work Monday through Friday. Occasional weekend availability may be required based on business needs.

     

    TRAVEL

    • Up to 5% travel required for customer visits, supplier audits, or training.

    Numbers & Facts

    LocationShirley, MA

    Skills

    • 8Dunmatched
    • AS 9100unmatched
    • Aerospace and Defenseunmatched
    • American Society for Quality (ASQ)unmatched
    • Analysis Skillsunmatched
    • Auditingunmatched
    • Blueprintsunmatched
    • Calibrationunmatched
    • Capability Maturity Model (CMM)unmatched
    • Certified Quality Engineer (CQE)unmatched
    • Coachingunmatched
    • Computerized Maintenance Management System (CMMS)unmatched
    • Corrective and Preventative Action (CAPA) Systemsunmatched
    • Customer Escalationsunmatched
    • ERP (Enterprise Resource Planning)unmatched
    • Employee Orientationunmatched
    • Engineeringunmatched
    • Experiment Designunmatched
    • Geometric Dimensioning and Tolerancingunmatched
    • ISO (International Organization for Standardization)unmatched
    • ISO 9001unmatched
    • Internal Auditunmatched
    • Leadershipunmatched
    • Maintain Complianceunmatched
    • Manufacturingunmatched
    • Medical Equipmentunmatched
    • Mentoringunmatched
    • Microsoft Officeunmatched
    • Minitabunmatched
    • Performance Analysisunmatched
    • Performance Managementunmatched
    • Performance Reviewsunmatched
    • Presentation/Verbal Skillsunmatched
    • Problem Solving Skillsunmatched
    • Process Capabilityunmatched
    • Process Improvementunmatched
    • Process Validationunmatched
    • Product Planningunmatched
    • Product Programsunmatched
    • Product/Service Launchunmatched
    • Project/Program Managementunmatched
    • Quality Engineeringunmatched
    • Quality Managementunmatched
    • Quality Metricsunmatched
    • Quality System Requirements (QSR)unmatched
    • Registrarunmatched
    • Riskunmatched
    • Root Cause Analysisunmatched
    • Six Sigma Black Beltunmatched
    • Statisticsunmatched
    • Statistics Softwareunmatched
    • Strategic Planningunmatched
    • Systems Analysisunmatched
    • Technical Leadershipunmatched
    • Time Managementunmatched
    • Training Program Developmentunmatched
    • United States Department of Energy (DOE)unmatched
    • Vendor/Supplier Evaluationunmatched
    • Vision Comparatorunmatched
    • Willing to Travelunmatched
    • Writing Skillsunmatched

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