Senior Quality Engineer

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

We are seeking an experienced Senior Quality Engineer to support new technology introduction, validation, and quality engineering initiatives for a global medical device organization. This role will serve as the Quality representative on cross-functional project teams, ensuring new products, processes, test methods, and technologies are successfully transitioned into production while meeting regulatory, quality, and timeline requirements.

Responsibilities

• Serve as the Quality Engineering lead on cross‑functional teams supporting new technology and product introduction into manufacturing.
• Develop, execute, and maintain validation protocols for new products, manufacturing processes, test methods, equipment, and software.
• Lead revalidation activities resulting from engineering changes, deviations, system upgrades, or material changes.
• Apply statistical analysis to validation activities and establish appropriate production inspection methods, controls, and acceptance criteria.
• Perform quality and risk analyses to identify and mitigate potential risks throughout development and implementation.
• Partner with R&D and Engineering to establish and document Critical-to-Quality (CTQ) characteristics and inspection requirements.
• Lead Design for Inspection activities for new technology introductions, leveraging appropriate technologies to improve consistency and reduce human error.
• Ensure project and operational compliance with applicable Quality Management System requirements, including FDA Quality System Regulations and ISO 13485/ISO 9001.
• Provide technical Quality Engineering support for root cause analysis, complaint investigations, deviations, and corrective and preventive actions.
• Support problem‑solving initiatives for new and established manufacturing processes to reduce compliance risk, scrap, rework, and process variability.
• Provide Quality Engineering guidance and influence cross‑functional stakeholders to drive effective, compliant solutions

Qualifications & Experience

• Bachelor’s degree in Mechanical Engineering, Industrial Engineering, or a related technical/engineering discipline.
• 3–5+ years of Quality Engineering experience within a regulated industry, preferably medical devices.
• Demonstrated experience supporting the introduction of new products, processes, equipment, or technologies within a medical device manufacturing environment.
• Strong experience with product verification, process validation, and test method validation.
• Working knowledge of medical device regulatory and quality requirements, including FDA requirements and ISO 13485.
• Experience applying statistical methods and risk‑management techniques within validation and manufacturing environments.
• Strong root cause analysis, problem‑solving, and corrective action experience.
• Ability to manage multiple projects and priorities while working effectively across Engineering, R&D, Manufacturing, and Quality teams.

Key Competencies

• Strong communication and influencing skills
• Cross‑functional collaboration and teamwork
• Project management and organizational skills
• Methodical, detail‑oriented approach
• Strong technical and analytical problem‑solving abilities
• Adaptability within a global, culturally diverse organization
• Ability to navigate challenging situations constructively and drive alignment