Quality Eng - P2

Boston Scientific•,

3d•$52,300 - $99,400

About The Position

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. Quality Eng - P2 (Quality Engineer II) Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products.

Requirements

Bachelor’s degree in engineering with at least 3 years of experience or an equivalent combination of education and work experience
Knowledge of Quality System Mfg Process
General Knowledge of industry practices, techniques, and standards
knowledge of standard statistical analysis techniques and problem-solving methodologies, including capability studies
Medical Device Manufacturing Process expertise
Knowledge of Quality and Traceability Systems (MESS/SAP/eCAPA/Windchill)
General knowledge of quality metrics
Flexibility to work other shifts as needed
Fully Bilingual

Responsibilities

Identifies and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. May be responsible for querying & bounding data to support implementation of complex & documenting release criteria.
Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members. May be responsible for creating risk analyses and FMEAs.
Develops Process Monitoring Systems by identifying critical process steps applying methods to reduce process variation in order to reduce/eliminate the cause of defects.
Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development.
Assists in creation of Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials, and by helping to identify more effective tools & materials.
Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation. Could serve as auditor of areas of the BSC quality system, such as development and manufacturing, as assigned.
Responsible for the final Process Monitor Release for products prior to distribution.