Senior Quality Engineer

Job Description

Job Description

Company Description

usion Life Sciences Technologies is a WBE-certified Healthcare Staffing and Engineering Services provider supporting industries including Pharma, Medical Devices, Aeronautical, Supply Chain, Heavy/Light Industrial, Food & Beverage, and Automotive. We proudly partner with 120+ clients such as Johnson & Johnson, Haemonetics, Delta, Caterpillar, Artisan Chef, Baxter, and many more. Our wide network of consultants and contract-to-hire engineers brings deep expertise across Engineering, Technical, Administrative, Healthcare, Life Sciences, Blue Collar, Skilled Trades, IT, Software Development, Manufacturing, and Supply Chain sectors. What sets us apart is our AI-powered, in-house software's enabling us to source and screen top talent within hours. This ensures rapid response times, high-quality matches, and virtually zero attrition. We support multiple engagement models including Time & Material, Staff Augmentation, Fixed-Bid, MSP, and C2C. ✨ Our Promise: Building America by delivering high-skilled candidates, Project based Suppport cost-effectively with rapid turnaround times. What We Do: For candidates: We connect them with opportunities that drive long-term career growth. For clients: We deliver talent within 24 hours, cost-effectively and execute projects end-to-end—on time, on budget, and without compromising quality.

Job Description

 

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

Ideal Candidate Profile
The ideal candidate is a hands-on Quality Engineer who can operate effectively within a complex Medical Device environment and partner with Engineering, R&D, Manufacturing, and other stakeholders to introduce new technologies while maintaining regulatory compliance and product quality. Qualifications

Quality Engineer, PLM, WindChill, Documentation, Medical Device industry

Additional Information

All your information will be kept confidential according to EEO guidelines.