Senior Quality Engineer,Quality Operations Job Marlborough area,Massachusetts USA,Quality Assurance

Senior Quality Operations Engineer, Quality Operations

The Senior Quality Operations Engineer, Quality Operations is an experienced quality engineering professional responsible for independent ownership of complex production and process control activities supporting IVD design transfer, commercial manufacturing, and sustained process performance.

This role applies deep technical judgment to investigations, process validation, change control, supplier quality issues, and operational quality decisions, and is expected to coach others while serving as a strong cross-functional partner.

Responsibilities

Independently lead complex quality engineering activities across receiving inspection, acceptance activities, manufacturing support, and process control execution.

Lead technical investigations for nonconformances, deviations, process failures, material issues, and recurring quality trends; identify robust root causes and drive timely resolution.

Develop, review, and approve validation protocols and reports for equipment qualification, process validation, revalidation, and validation changes, ensuring scientifically sound rationale and compliant execution.

Lead quality review of production and process changes, ensuring change impact is appropriately assessed for product quality, regulatory compliance, validation state, and risk controls.

Provide quality engineering leadership during design transfer and manufacturing readiness activities, including control plan review, inspection strategy, process risk evaluation, and readiness assessments.

Partner with supplier quality, Manufacturing, and operations teams on supplier-related nonconformances, SCARs, incoming quality trends, and qualification-related issues.

Drive CAPAs and quality improvement actions for systemic manufacturing and process control issues; challenge weak problem statements, unsupported root causes, and ineffective actions.

Review and approve engineering and quality documentation within delegated authority, including protocols, reports, nonconformance records, CAPAs, change records, and related technical assessments.

Support audits, regulatory inspections, and back-room documentation for manufacturing quality topics; help ensure evidence is technically complete and inspection ready.

Mentor junior engineers and technicians on GMP expectations, GDP, investigations, risk-based decision-making, and validation discipline.

Generate and interpret quality metrics for process capability, nonconformances, CAPA performance, supplier quality, and operational trends, and escalate adverse signals appropriately.

Qualifications

Required Work Experience:

5+ years of progressive experience in quality engineering, manufacturing quality, or quality operations in a regulated medical device or IVD environment.
Strong working knowledge of FDA QMSR, ISO 13485, GMPs, process validation, and production/process control requirements.
Demonstrated experience supporting design transfer, equipment qualification, process validation, supplier quality, investigations, CAPA, and change control.
Ability to make technically sound, risk-based quality decisions with limited supervision.
Strong facilitation, influencing, technical writing, and structured problem-solving skills.
Working knowledge of eQMS and quality analytics tools.

Preferred Work Experience:

Experience in IVD product development, design change governance, or sustaining product design and development product lifecycle support.
Experience in complex IVD manufacturing environments involving reagent, consumable, software-enabled, or instrument-based products.
Working knowledge of ISO 14971, statistical techniques, process capability methods, and electronic quality systems.

Physical and Mental Requirements:

Strong attention to detail for thorough documentation to ensure consistency in documentation.
Excellent problem-solving skills to identify and address quality issues effectively.
Ability to manage multiple projects to meet deadlines while maintaining accuracy.

Knowledge:

Strong working knowledge of FDA QMSR, ISO 13485, ISO 14971, and practical application of risk-based quality system management.

Skills:

In-depth knowledge of QMS standards…

Senior Quality Engineer, Quality Operations