Supplier Quality Engineer InfraReDx
THIS JOB HAS EXPIRED Provides focused engineering support to assure the Company that our suppliers have the capability to provide a high quality material or service that meet the high expectations of the Company?s product quality. Key team member providing expertise on the capability of our suppliers within appropriate engineering group, including Manufacturing, R&D, Quality, and Finance. Develops, establishes and maintains plans to manage the technical activities of our suppliers, ensuring they meet corporate requirements.
Works closely with Receiving Inspection, Manufacturing, Purchasing, and Engineering in the assurance that all suppliers are capable of providing materials and services that satisfy corporate requirements.
Responsible for coordination of initial component quality requirements including writing validations and coordinating with appropriate groups.
Interfaces with suppliers to obtain quality data, as needed, to evaluate supplier approval, changes, and the resolution of quality issues.
Maintains supplier quality records in accordance with FDA/GMP requirements.
Lead external quality management activities such as supplier CAPA programs, supplier approval, and supplier auditing.
Acts as a team member in supporting quality disciplines, decisions, and practices.
Participates in resolving any internal conflicts and coordinates appropriate corrective and preventive action with suppliers.
Supports activities for ?ship to stock? program as required.
Oversees incoming inspection function.
Bachelor of Science degree in a technical discipline.
5-7 years of quality engineering in life sciences industry.
Proven track record with supplier selection, approval, and management.
Strong written/verbal communication skills and demonstrated used of Quality tools/methodologies.
Microsoft (Word, Excel, Powerpoint, Project and Access) experience.
Working knowledge of FDA/QSR, ISO/MDD standards, process validation, product design control, CAPA, FMEA and six sigma methodologies.
Current ASQ (CQM, CQE, and/or CQA) certificatio
||34 Third Avenue |
Burlington, MA 01803
THIS JOB HAS EXPIRED