Senior Quality Engineer

IntePros; Bridgewater (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

IntePros is seeking an experienced Senior Quality Engineer to support a major Digital Transformation and New Technology Introduction initiative within a regulated Medical Device manufacturing environment.

This role represents Quality on cross-functional project teams responsible for implementing new technologies and processes into production, ensuring quality, compliance, validation and operational readiness.

Qualifications

• Bachelor's degree in Mechanical Engineering, Industrial Engineering or another relevant technical/engineering discipline.
• Minimum 3–5 years of Quality Engineering experience within a regulated industry, with Medical Device experience strongly preferred.
• Demonstrated experience successfully implementing or introducing new technology within the Medical Device industry.
• Strong hands-on knowledge of product verification, process validation and test method validation.
• Experience developing and executing validation protocols for equipment, processes, test methods and/or software.
• Working knowledge of applicable FDA Medical Device Quality/GMP requirements and ISO 13485.
• Experience with Quality risk-management techniques and statistical methods used within validation and manufacturing environments.
• Strong understanding of manufacturing Quality Systems, inspection methodologies, investigations and corrective actions.
• Experience supporting New Technology Introduction, manufacturing automation, digital transformation or Industry 4.0 initiatives is highly desirable.

Responsibilities

• Represent Quality on cross-functional teams responsible for Digital Transformation, New Technology Introduction and implementation into production.
• Ensure new technologies, systems and processes are implemented in compliance with applicable Quality requirements and project timelines.
• Develop, compile and execute validation protocols for new products, processes, test methods and software.
• Support revalidation activities resulting from engineering changes, deviations, system upgrades, material changes or other process modifications.
• Apply statistical analysis to validation activities and help establish appropriate production inspection strategies and controls.
• Perform Quality risk assessments to identify and mitigate potential compliance and product risks during development and implementation.
• Partner with R&D and Engineering to identify, establish and document Critical-to-Quality (CTQ) characteristics and inspection requirements.
• Lead Design for Inspection activities for New Technology Introduction, leveraging new technologies and automation where appropriate to reduce human error.
• Ensure ongoing compliance with established Quality Systems and applicable FDA Quality System/GMP and ISO 13485/9001 requirements.
• Provide Quality Engineering support for problem analysis, investigations and corrective actions.
• Partner with cross-functional teams to troubleshoot issues associated with new technology and established manufacturing processes.
• Identify opportunities to reduce compliance risk, scrap, rework and reprocessing while maintaining product quality.
• Maintain appropriate validation, Quality and project documentation throughout technology implementation.

Education

Bachelor's degree in Mechanical Engineering or Industrial Engineering or another relevant technical/engineering discipline

Tools

FDA QMS understanding

ISO 13485

Job description

Senior Quality Engineer – Digital Transformation

Industry: Medical Device

We are seeking an experienced Senior Quality Engineer to support a major Digital Transformation and New Technology Introduction initiative within a regulated Medical Device manufacturing environment. This individual will represent Quality on a cross-functional project team responsible for implementing new technologies and processes into production while ensuring the highest standards of quality, compliance, validation, and operational readiness.

The ideal candidate will bring a strong Quality Engineering foundation within the Medical Device industry, with hands-on experience introducing new technology into a regulated manufacturing environment. This role will work closely with Engineering, R&D, Manufacturing and other cross-functional partners throughout technology implementation, validation and production deployment.

Key Responsibilities

• Represent Quality on cross-functional teams responsible for Digital Transformation, New Technology Introduction and implementation into production.
• Ensure new technologies, systems and processes are implemented in compliance with applicable Quality requirements and project timelines.
• Develop, compile and execute validation protocols for new products, processes, test methods and software.
• Support revalidation activities resulting from engineering changes, deviations, system upgrades, material changes or other process modifications.
• Apply statistical analysis to validation activities and help establish appropriate production inspection strategies and controls.
• Perform Quality risk assessments to identify and mitigate potential compliance and product risks during development and implementation.
• Partner with R&D and Engineering to identify, establish and document Critical-to-Quality (CTQ) characteristics and inspection requirements.
• Lead Design for Inspection activities for New Technology Introduction, leveraging new technologies and automation where appropriate to reduce human error.
• Ensure ongoing compliance with established Quality Systems and applicable FDA Quality System/GMP and ISO 13485/9001 requirements.
• Provide Quality Engineering support for problem analysis, investigations and corrective actions.
• Partner with cross-functional teams to troubleshoot issues associated with new technology and established manufacturing processes.
• Identify opportunities to reduce compliance risk, scrap, rework and reprocessing while maintaining product quality.
• Maintain appropriate validation, Quality and project documentation throughout technology implementation.

Qualifications

• Bachelor's degree in Mechanical Engineering, Industrial Engineering or another relevant technical/engineering discipline.
• Minimum 3–5 years of Quality Engineering experience within a regulated industry, with Medical Device experience strongly preferred.
• Demonstrated experience successfully implementing or introducing new technology within the Medical Device industry.
• Strong hands-on knowledge of product verification, process validation and test method validation.
• Experience developing and executing validation protocols for equipment, processes, test methods and/or software.
• Working knowledge of applicable FDA Medical Device Quality/GMP requirements and ISO 13485.
• Experience with Quality risk-management techniques and statistical methods used within validation and manufacturing environments.
• Strong understanding of manufacturing Quality Systems, inspection methodologies, investigations and corrective actions.
• Experience supporting New Technology Introduction, manufacturing automation, digital transformation or Industry 4.0 initiatives is highly desirable.

The successful candidate will be a methodical, collaborative and solutions-oriented Quality professional who can effectively operate within a cross-functional project environment. Strong communication and influencing skills are essential, along with the ability to balance Quality and compliance requirements with project timelines and operational needs.

We are looking for someone who is flexible, culturally aware and comfortable working across Engineering, R&D, Manufacturing and Quality teams. The ideal candidate will be a strong team player who can help resolve issues constructively, manage competing priorities and drive new technologies into production without compromising Quality or compliance.