Job Description

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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.

Quality Engineer I, CIS

About the role:

The CIS Quality Engineer I is an active participant within the Business Unit Complaint Investigation Site (CIS). This role is responsible for managing the customer complaint failure analysis process for assigned product families; coordinating additional investigation with Business Unit Quality and/or the Supplied Finished Medical Device Manufacturer (SFMD); monitoring trending of product performance data and providing interpretive summaries of results; ensuring compliance with policy, procedures, and regulations applicable to Post Market Surveillance complaint handling, and working with BU Quality and SFMD partners to manage CAPA issues associated with complaints.

Your responsibilities include:

* Manage the Complaint Investigations including completion of return product evaluations, DHR review, ship history to ensure Complaints are investigated and closed in a timely manner
* Perform tasks to obtain adequate information to ensure proper documentation and closure of each complaint investigation.
* Sustain product complaint investigation activities for the Complaint Investigation Site (CIS) for assigned product families.
* Apply engineering principles to the analysis of complaint medical devices.
* Interface with intra/inter-site personnel to facilitate timely analysis of customer complaints and/or returned product.
* Manage failure investigations including probable cause determinations with thorough, accurate, and timely documentation of findings.
* Work closely with BSC Design Assurance/Sustaining Engineering on complaint product evaluation and provide detailed analysis of results as well as identify and recommend actions to cross functional teams for resolving device issues.
* Work with Sourced Finished Medical Device (SFMD) partners to drive investigation closure.
* Assist SFMD partners to conduct on-site failure investigations and visits as needed.
* Participate in the development of protocols/plans/procedures/requirements for testing of returned customer complaint units in support of companys quality program.
* Apply existing techniques and procedures with recommendations and implementation of modification for improved efficiency or develop new analytical methods and techniques.
* Promote Good Laboratory Practices and comply with site safety and health hazard requirements when working in the lab and when working with lab personnel.
* Become proficient in the use and maintenance of applicable equipment and/or tools.

What were looking for in you:

* Bachelor of Science degree and/or Science Related discipline. Bio medical engineering is preferred.
* Excellent written and oral communication skills along with good presentation and technical writing
* Works independently or in a team environment.
* Takes initiative and proactively seeks quality solutions through continuous improvement
* Effective priority setting
* Must have good analytical and problem-solving skills
* Strong working knowledge of Microsoft Office applications
* Travel may be required 5-15%

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

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Requisition ID: 476255