Find & Apply For Validation Engineer Jobs in Bridgewater, Massachusetts

Senior Quality Engineer -

Digital Transformation Location:

Bridgewater & Raynham, MA Primary Location:

Bridgewater, MA Job Type:

Contract - Up to 12 Months Position Summary We are seeking an experienced Senior Quality Engineer to support a Digital Transformation project within the Medical Device industry. The Senior Quality Engineer will represent Quality as part of a cross-functional team and support the successful introduction and implementation of new technologies into production while ensuring the highest standards of quality, regulatory compliance, and project execution. The ideal candidate will have 3-5+ years of Quality Engineering experience within a regulated industry- Medical Devices, along with strong expertise in validation, verification, risk management, statistical analysis, and FDA/ISO requirements. Key Responsibilities Represent Quality as a member of cross-functional project teams to ensure successful delivery of new technologies into production while maintaining quality, compliance, and project timelines. Develop, compile, execute, and review validation protocols for new test methods, products, processes, and software. Ensure validation activities are implemented in accordance with established procedures and regulatory requirements. Perform and coordinate revalidation activities resulting from engineering changes, deviations, system upgrades, or material changes. Apply statistical analysis as part of validation activities and use results to establish appropriate inspection requirements and production controls. Conduct Quality Assurance risk assessments and risk analyses to identify and mitigate potential risks associated with new technology development and implementation. Collaborate with R&D to identify, define, and document Critical-to-Quality (CTQ) characteristics and associated inspection requirements. Lead Design for Inspection (DFI) activities for New Technology Introduction (NTI) projects, with a focus on improving inspection effectiveness and reducing human error. Ensure compliance with applicable quality systems and regulatory requirements, including FDA Quality System Regulation (QSR) and

ISO 13485/ISO 9001

requirements. Provide technical support for root cause analysis, problem-solving, and complaint investigations . Work cross-functionally to identify effective corrective actions and drive resolution of quality issues. Support troubleshooting and problem-solving for both new technologies and established production processes. Identify opportunities to reduce compliance risks, scrap, rework, and process inefficiencies. Maintain appropriate quality documentation and ensure project activities are completed in accordance with established quality procedures. Required Qualifications & Experience Bachelor's degree or equivalent qualification in Mechanical Engineering, Industrial Engineering, Quality Engineering, or another relevant technical/engineering discipline . 3-5+ years of Quality Engineering experience within a regulated industry. Medical Device industry experience strongly preferred. Proven experience supporting the introduction and implementation of new technologies within a Medical Device manufacturing environment. Strong knowledge and hands-on experience with: Product Verification Process Validation Test Method Validation Equipment/Software Validation Quality Risk Management Statistical Analysis Root Cause Analysis and Corrective Actions Working knowledge of

FDA QSR/GMP

requirements applicable to Medical Devices. Strong understanding of ISO 13485 and

ISO 9001

quality management systems. Experience working in cross-functional project teams and supporting technology transfer or New Technology Introduction activities. Strong documentation, analytical, problem-solving, and project management skills. Key Competencies Strong cross-functional collaboration and teamwork Effective influencing and stakeholder-management skills Project management capabilities Methodical and analytical approach to problem-solving Strong communication skills Flexible and adaptable Culturally aware and collaborative Ability to work effectively across technical and business functions Strong Quality generalist with hands-on industry experience Ability to de-escalate issues and facilitate constructive resolution

Pay:

$60.00 - $80.00 per hour Expected hours: 40.0 per week

Work Location:

In person