Senior Supplier Quality Engineer at The Judge Group Inc. in Marlborough, Massachusetts

Job Description:

Location: Marlborough, MA

Description: Our Client is looking for a new Sr Supplier Quality Engineer. This will be for a full time opportunity and will be fully onsite in Marlborough, MA.




Summary of Primary Duties and Responsibilities:

• Ensure suppliers provide high-quality materials and services that meet product quality and regulatory requirements.


• Serve as a key team member, offering expertise on supplier capabilities, establishing and maintaining technical activities, and ensuring suppliers meet business needs.

Responsibilities:

• Participate in core teams for development projects and manufacturing transfers with internal or external facilities.


• Use a risk-based approach to classify and manage suppliers.


• Address supplier issues at incoming inspection or on the manufacturing floor.


• Resolve quality issues, including supplier non-conformances, corrective action requests, and CAPA.


• Lead the qualification of new suppliers, including selection and approval.


• Coordinate initial component quality requirements, including first article inspection, process qualification, and support supplier validation activities.


• Provide insights on supplier capabilities for new and existing products in collaboration with manufacturing, engineering, R&D, and marketing.


• Conduct external supplier audits to ensure compliance and manage quality issues observed during audits.


• Execute and enforce Supplier and/or Distributor Quality Agreements.


• Maintain supplier quality records in accordance with FDA/GMP and EU MDR requirements.


• Lead the review of supplier change requests with cross-functional teams, including evaluation, implementation planning, and approval.


• Generate KPIs and supplier metrics, including quarterly scorecards for the supply base.


• Identify under-performing suppliers and work with them to improve or reduce defect rates, initiating transfer activities to alternative suppliers if necessary.


• Consolidate the supply base by identifying redundant capabilities and supporting manufacturing or service transfers.


• Initiate and drive process/yield improvement projects.


• Develop and support requirements and activities for the "dock-to-stock" program.


• Work independently to manage all requirements of the supplier management program and propose continuous improvements.


• Mentor and develop quality personnel and organizational partners.


• Support contract manufacturers on quality issue resolution and change requests.

Requirements:

• Experience in the medical device or life sciences industry.


• Strong written and verbal communication skills with demonstrated use of quality tools and methodologies.


• Knowledge of design control requirements and the manufacturing design transfer process.


• Familiarity with FDA/QSR, ISO/EU MDR standards, process validation, product design control, CAPA/SCAR, and FMEA methodologies.


• Proficiency with Microsoft Office applications.


• Certified Internal Auditor and/or experience performing internal audits is strongly preferred.


• Current ASQ and/or Six Sigma certifications are preferred.

Contact: cbeasty@judge.com


This job and many more are available through The Judge Group. Find us on the web at www.judge.com Apply Now