Senior Quality Engineer – New Technology & Validation Lead

Intepros; Bridgewater (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Intepros is seeking an experienced Senior Quality Engineer to support new technology introduction, validation, and quality initiatives for a global medical device organization. You will be the Quality representative on cross-functional project teams, ensuring new products, processes, test methods, and technologies transition into production while meeting regulatory, quality, and timeline requirements.

The role emphasizes validation protocols, risk analyses, CTQ characterization, and Design for

Qualifications

• Bachelor's degree in mechanical, industrial or related engineering field.
• 3–5+ years of Quality Engineering in regulated environments, preferably medical devices.
• Experience supporting introduction of new products, processes, equipment, or technologies in medical device manufacturing.
• Strong experience with product verification, process validation, and test method validation.
• Knowledge of FDA requirements and ISO 13485 quality systems.
• Experience applying statistical methods and risk management in validation/manufacturing.
• Strong root cause analysis and corrective action experience.
• Ability to manage multiple projects across cross-functional teams.

Responsibilities

• Serve as Quality Engineering lead on cross‑functional teams for new technology/product introduction into manufacturing.
• Develop, execute, and maintain validation protocols for new products, processes, test methods, equipment and software.
• Lead revalidation activities due to engineering changes, deviations, system upgrades, or material changes.
• Apply statistical analysis to validation activities and establish production inspection methods, controls, and acceptance criteria.
• Perform quality and risk analyses to identify and mitigate risks in development and implementation.
• Collaborate with R&D and Engineering to define CTQ characteristics and inspection requirements.
• Lead Design for Inspection activities leveraging technologies to reduce human error.
• Ensure compliance with QMS requirements including FDA QSR and ISO 13485/9001.
• Provide technical QI support for root cause analysis, investigations, deviations, CAPAs.
• Support problem-solving initiatives to reduce compliance risk, scrap, rework, and process variability.
• Provide QI guidance to cross-functional stakeholders for compliant solutions.

Education

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Industrial Engineering

Job description

Intepros is seeking an experienced Senior Quality Engineer to support new technology introduction, validation, and quality initiatives for a global medical device organization. You will be the Quality representative on cross-functional project teams, ensuring new products, processes, test methods, and technologies transition into production while meeting regulatory, quality, and timeline requirements.

The role emphasizes validation protocols, risk analyses, CTQ characterization, and Design for