QA Engineer II Job
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POST DATE 9/18/2016
END DATE 10/9/2016
Boston Scientific Corporation
Arden Hills, MN
JOB DESCRIPTIONPRIMARY LOCATION: US-MN-Arden Hills
ADDITIONAL LOCATIONS: (n/a)
REQUISITION ID: 289581
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.
FUNCTION OR DIVISIONAL OVERVIEW
At Boston Scientific, our products and technologies are used to diagnose or treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. In Cardiac Rhythm Management (CRM) we offer solutions for treating irregular heart rhythms and heart failure, and protecting against sudden cardiac arrest. Boston Scientific develops, manufactures, and markets a broad array of products and services that enable less-invasive care for some of the most threatening cardiac conditions. We've been expanding indications and conducting pivotal research for nearly 20 years, resulting in increased access to the lifesaving and life-enhancing benefits of ICD and CRT therapies
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.
- 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.
- BS with 2-4 years of relevant experience or MS with 0 - 2 years of experience
- 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
- Engineering degree with 1-3 years of relevent experience
- 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
QUALITY SYSTEM REQUIREMENTS
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
BOSTON SCIENTIFIC (NYSE: BSX) TRANSFORMS LIVES THROUGH INNOVATIVE MEDICAL SOLUTIONS THAT IMPROVE THE HEALTH OF PATIENTS AROUND THE WORLD. AS A GLOBAL MEDICAL TECHNOLOGY LEADER FOR MORE THAN 30 YEARS, WE ADVANCE SCIENCE FOR LIFE BY PROVIDING A BROAD RANGE OF HIGH PERFORMANCE SOLUTIONS THAT ADDRESS UNMET PATIENT NEEDS AND REDUCE THE COST OF HEALTHCARE. FOR MORE INFORMATION, VISIT US AT WWW.BOSTONSCIENTIFIC.COM.
Boston Scientific (NYSE: BSX) transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 30 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.
Boston Scientific is an Equal Opportunity Employer.
Posting Notes: US-MN-Arden Hills||(n/a)||Quality||(n/a)
Nearest Major Market: Minneapolis
Job Segment: Manufacturing Engineer, Engineer, CAPA, Quality Engineer, R&D Engineer, Engineering, Management