Senior Quality Engineer

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 35 years of Quality Engineering experience within a regulated industry- Medical Devicesalong 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
Bachelors degree or equivalent qualification in Mechanical Engineering Industrial Engineering Quality Engineering or another relevant technical/engineering discipline.
35 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.

Remote Work :

No

Employment Type :

Full-time