Sr/Pr Supplier Quality Engineer - Medical Devices

Job Description: General Summary: Provide support for all Supplier Quality related activities. Assist in Receiving Inspection operations, supplier survey/ audit responsibilities, and new product development operations.


Specific Duties and Responsibilities

Monitor, analyze, and report on supplier performance to provide key performance information to the department manager, senior management, and outside departments.

Assist suppliers in formation of statistical sampling plans, inspection methodology, and procedures.

Provide technical consultation to others on statistically valid sampling plans for inspection and acceptance criteria

Serve as technical resource for process improvements projects such as alternative measurement/testing methodologies, and supplier supplied data, and Master Lot qualification programs.

Problem solving through classical & experimental design methods

Assists Incoming Quality in resolving internal and external audit findings and observations, non-conformance reports, and corrective actions as needed.

Provide hands-on technical support for Receiving Inspection personnel as required.

Develop procedures for the purpose of improving IQC and supplier support processes. Initiates ECO's as necessary.

Responsible for the development of inspection methods for new materials, components, and sub-assemblies

Review and improve sampling plans for new or existing materials and components.

Review incoming material and/or in-process rejections and determine appropriate corrective actions.

Serve as part of auditing teams and as lead auditor for Supplier Quality, as required.

Follow-up responsibility for Supplier Corrective Actions.

Assist in the qualification, selection, and development of new suppliers as needed.

Member of new product development teams.

Occasional extensive travel to suppliers as required.

Performs responsibilities required by the Quality System and other duties as assigned or requested.

Undertakes special assignments at the direction of the SQE manager.


* Indicates Essential Function

Position Qualifications

Minimum education: Bachelor Degree, (masters degree preferred) in Applied Science/Engineering related fields, or equivalent experience. Bachelor's in Mechanical or Industrial Engineering preferred. ASQ certification (CQE, CQA, CRE) strongly desired.

Minimum experience: At least six years experience in a supplier quality or quality engineering function, two years in a medical device environment, or equivalent combination of education and experience to perform at this level. Thorough understanding of inspection techniques,statistical methods, and design of experiments. Knowledge of QSR's and computer literacy required. Expertise in the areas of statistical plans and lot acceptance sampling methodologies. Experience working in a manufacturing & product development environment. Requires planning and organizational skills in complex technical functions. Ability to work under pressure with multiple priorities. Extensive knowledge of ISO/QSR requirements.

Searchable Keywords: Sr/Pr Supplier Quality Engineer mrb incoming audit medical device sqe qe / gj-mo

Minimum Education Required: Bachelor

Expected Travel Time: About 25%


Boston Scientific offers incredible opportunities to grow and advance, a dynamic work environment and an excellent benefits package. Boston Scientific is an equal opportunity employer, M/F/D/V.