Senior Quality Engineer - MedTech Digital Transformation

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

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.