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Quality Specialist

4 months ago

South Lake Tahoe, California, United States Boston Scientific Full time

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.

Specialist I, Quality

Serve as Quality representative on product/process quality initiatives in support of manufacturing activities and other quality goals and priorities. Collaborates cross-functionally in the execution of projects designed to improve the compliance, efficiency and effectiveness of specific quality system elements. Provides guidance and/or mentorship in CAPA systems and related processes.

  • Support departmental or cross-functional quality initiatives or projects by applying technical and quality system principles.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, investigating and resolving quality issues.
  • Assist site's leadership in the collection, review, trending and/or reporting of quality data in support of Management Review.
  • Provide direction and mentoring to CAPA/NCEP owners, including timely tracking, follow up and closure of NCEPs/CAPAs in their different phases.
  • Interpret applicable internal and external regulatory requirements, regulations, and standards, as applicable.
  • Participate cross functionally in global quality system projects and/or harmonization initiatives.
  • Participate in internal and/or external audits as required by Management.
  • Educate functional areas on quality system requirements.
  • Other duties as necessary or required by the department or site.

Management Requirements

  • Bachelor's Degree in science or Engineering preferred and 3+ years of related work experience.
  • Experience working in manufacturing area, Neuromodulation preferred.
  • Understanding of product design concept with applicability on manufacturing environment.
  • Knowledge in Quality Systems and Identification Traceability Systems (e.g. eCAPA, Windchill, MES, SAP, IQS, etc).
  • General knowledge in quality metrics.
  • Experience in problem solving activities, identification of root causes and understanding corrective and preventive actions.
  • Willing to work different shits (1st, 2nd, 3rd and/or weekends) as needed
  • Fully Bilingual

Requisition ID: 574337

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 free workplace. 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.