Quality Engineer II, CIS
About the role:
The CIS Quality Engineer II 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:
- Sustain product complaint investigation activities for the Complaint Investigation Site (CIS)
- Interface with intra and inter site personnel to facilitate timely analysis of customer return product classified as a complaint
- Become proficient in the use and maintenance of applicable equipment and/or tools
- Manage failure investigations including probable cause determinations and documentation of findings
- Interpret and evaluate the product analysis, and recommend the need for additional actions including initiating CAPA’s and working with BU and SFMD partners to drive their closure.
- Works closely with BSC Design, Sustaining, AQM engineering personnel on performing product evaluation, final analysis, reporting of such analysis and CAPA’s
- Assist SFMD partners as needed to conduct on-site failure investigations and visits
- Accountable for managing thorough and accurate complaint investigation records, as well as timely closure of complaint investigations
- Participate in the development of protocols/plans/procedures/requirements for testing of returned customer complaint units in support of company’s 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
- Works cross-functionally (SFMDs, engineering, clinical/medical) in identifying and resolving issues
- Work w/ BU Compliance, Engineers, and SFMD QA personnel insupportof various quality systems including but not exclusive to:
- Management controls
- Corrective and Preventive Actions (CAPA)
- Supplier management
What we’re looking for in you:
- BS/BA in Engineering and/or Science Related discipline
- 3-5 years in Quality role
- 1+ years in the medical device industry OR solid background in QSR and MDD Quality System requirements
- Proficiency in MS-Office (Word, Excel, PowerPoint, Project, Visio)
- This position is in an office environment, with interaction with laboratories, BSC plants and external suppliers.
- Able to communicate at all organizational levels both within BSC and with outside companies.
- Able to work well in a team environment with peer group.
- Travel may be required 5-15%
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
Requisition ID: 421859