• United States Of America, Usa

Job Description:

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, were solving some of the most important healthcare industry challenges Together, were one global team committed to making a difference in peoples lives around the world This is a place where you can find a career with meaningful purposeimproving lives through your lifes 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

Analyzes customer complaints, events and other post market surveillance data by examining the data for patterns and trends and investigating when necessary
May be responsible for querying & bounding data to support implementation of complex & documenting release criteria
Investigates identified trends by starting a formal trend investigation and trend report and working on cross-functional teams
Documents trend action by updating the trend report at appropriate levels and by performing a Health Risk Analysis
Communicates product performance by formal presentations to management committees and design teams, supporting published product performance reports and supporting customer requests for performance information either directly or through the sales organization
Provides input for process improvement and helps develop tactical approaches to implement team strategies

What Were Looking For In You

Minimum Qualifications

BS with 4-8 years of relevant experience or MS with 2-4 years of experience
Understanding and a command of highly technical engineering and mathematic 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

Preferred Qualifications

Engineering degree with 4-8 years of relevant experience
A strong 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
Ability to independently learn automation tools such as Automation Anywhere is highly desirable
Experience supporting competent authority responses

About Us

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 youre looking to truly make a difference to people both around the world and around the corner, theres 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

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Others - other Industry
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 08th Apr 2020

Key Skills:

Company Profile:

Company
BOSTON SCIENTIFIC





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