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Quality Tech II
3 months ago
Additional Location(s): N/A
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance
At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.
About this role:
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.
Your responsibilities will include:
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
Requisition ID:585642
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.
Boston Scientific maintains a prohibited substance freeworkplace. Pursuant to Va. Code * , 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.
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.
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
