Boston Scientific Quality Tech II - 1st Shift 

United States, Minnesota, Arden Hills 

82284260

Performs product investigations associated with complaints, including handling of physical product returns ranging from Single Use Devices to Capital Equipment to system accessories. Reviews and investigates product return information, investigation conclusions and coding to ensure the investigation is adequately documented and the most probable conclusion code was selected based on the analysis/testing conducted. Communicate and collaborate with multiple, cross-site functions, including Design Quality, R&D, Supplier Management, Operations, other complaint functions, and senior leadership to ensure comprehensive product analysis and understanding appropriate to product risk. Responsible for identifying and implementing continuous improvements to improve product performance and complaint processes. Summarizes and reports on findings and observations.
Perform independent complaint investigations, analyzing returned product for cause of failure and document the results of the investigations and submit for approval.
Utilize testing techniques and available BSC test resources in support of investigations.
Data entry as necessary to track and trend complaint data.
Conduct data analysis and analytical report review to investigate complaint commonality and patterns to support complaint investigations. Includes review of manufacturing data.
Assist in the investigation and disposition of NCEPs and CAPAs.
Evolve and learn disposal of bio-hazardous materials per procedure.
Assist in presentation of complaint data at monthly complaint review meetings.
Interact with other departments regarding failure issues and investigations.
Participate in continuous improvement projects.
Support lab maintenance and improvement.
Required qualifications:

• High school degree/equivalent with 2+ years’ experience, or an equivalent combination of education/work experience
• Knowledgeable in Quality System Regulations, Medical Device Directive and ISO13485 Quality Standards.
• Must work well in a team environment
• Proficient with Microsoft Office tools including Word, Excel, PowerPoint and Outlook
• Good organizational, listening, and verbal/written communication skills with demonstrated ability to follow instructions and processes
• Strong ability to successfully multi-task and adaptability.

Preferred qualifications:

• Associates or bachelor’s degree in technical discipline
• Electrical or mechanical equipment experience.
• Self-starter with the ability to identify improvement opportunities
• Able to work independently under limited supervision as well as in a team environment
• Able to read, understand, and communicate procedural requirements
• 2 years of quality or manufacturing experience in medical device industry

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.