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Date: Mar 2, 2019
Company: Boston Scientific
Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.
About This Role:
This Quality Engineer role will investigate product complaints and monitor BSC product performance. The team uses product performance data to escalate post-market field performance signals into the CAPA process in collaboration with Return Device Analysis, R & D, Design Assurance, Medical Safety and the CAPA Management teams. This role provides for significant visibility across the quality organization. This engineer will have an opportunity to participate in standing-up new analytical tools and harmonization of post-market Trending and Analysis practices across BSC business units.
Will provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Will provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products.
Your Responsibilities Will Include:
- 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.
- Understanding and a command of highly technical engineering topics
- Ability to independently manage project work to define delivery dates
- Understanding and experience operating within quality system processes and procedures.
- A successful track record of cross organizational project collaboration
- Significant participation in the Hazard Analysis and Risk Assessment as related to trend management
- Strengths in communication (verbal and written) and data analysis skills
- A stong technical understanding of device therapy products
- Experience with the Quality system escalation process including NCEP initiation and escalation into the CAPA and PIR processes.
- Strong understanding of the Quality system and post-market complaint tracking, patterning and analysis
- Project experience and/or collaboration with Medical Safety, Design Assurance, Return Product Analysis, Supplier Development and Manufacturing
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
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