Senior Quality Engineer - Manufacturing - Littleton, MA

Michael Page
Littleton, US

Why this role

Pace
Steady
Collaboration
High
Autonomy
High
Decision Impact
Team
Role Level
Manager

Derived from job-description analysis by Serendipath's career intelligence engine.

What success looks like

  • effective verification and validation of products
  • improved quality culture
Typical background
5+ years of experience in Quality Engineering or Quality Assurance

Transferable backgrounds

  • Coming from quality assurance manager
  • Coming from quality control engineer

Skills & requirements

Required

Site-wide Quality StrategyProduct QualificationRisk ManagementISO StandardsCAPA ActivitiesRoot Cause Analysis

Preferred

NPI LeadershipCross-functional Mentorship

Stack & domain

Quality EngineeringQuality AssuranceIso 13485Iso 9001CapaRoot Cause AnalysisRisk ManagementAdvanced Problem-solving SkillsManufacturingRegulated Industries

About the role

Original posting from Michael Page via LinkedIn

  • Own site‑wide quality strategy and validation for complex products
  • High‑visibility role influencing NPI, risk, and regulatory compliance

About Our Client

This global manufacturing organization is part of a highly respected engineering group known for innovation, stability, and long‑term investment in its people. The business offers a collaborative culture, strong quality mindset, and exposure to technically complex products used in regulated industries.

Job Description

  • Lead and maintain site quality validation, product qualification, and risk management programs aligned to ISO and internal QMS standards
  • Provide quality engineering leadership to New Product Introduction (NPI) and design & development activities
  • Ensure effective verification and validation (V&V) of products and processes throughout the development lifecycle
  • Drive investigation of nonconformities, deviations, and customer complaints using structured problem‑solving methodologies
  • Lead and support CAPA activities through robust root cause analysis and data‑driven decision making
  • Oversee change management activities, ensuring all quality impacts are assessed, documented, and implemented correctly
  • Support and participate in internal audits, generating findings and driving continuous improvement
  • Coach, train, and mentor cross‑functional teams on quality tools, systems, and best practices
  • Promote a strong culture of quality, risk‑based thinking, and continuous improvement across the site

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.

The Successful Applicant

  • Bachelor's degree in Engineering or a scientific discipline
  • 5+ years of experience in Quality Engineering or Quality Assurance within a regulated manufacturing environment
  • Strong working knowledge of ISO 13485 and ISO 9001 standards
  • Proven experience with product and process validation methodologies
  • Advanced problem‑solving skills, including CAPA, root cause analysis, and risk management tools

What's On Offer

  • High‑impact position with ownership over site quality and validation strategy
  • Exposure to technically advanced products in regulated industries
  • Strong cross‑functional influence and leadership visibility
  • Excellent benefits, work‑life balance, and people‑first culture
  • Backing of a stable, global engineering group with long‑term growth

Contact: Emma White

Quote job ref: JN-052026-7018438

Source: Michael Page careers (LinkedIn)

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