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Boston Scientific

Medical devices maker for interventional specialties

Quality Tech 2

Validation, Compliance & Quality SystemsPosted on Nov 13
Full-timeArden Hills, MN, USA

About the Job

Requirements

  • A minimum of two years of experience with a high school diploma and/or equivalent experience, training, or apprenticeships.

Responsibilities

  • Assist engineering with manufacturing support by learning to analyze data and identify manufacturing issues and trends; train operators on basic processes and engineering changes; and conduct operator certification on-the-job training and testing.
  • Work with Engineering to identify manufacturing issues, determine root causes, and implement corrective and preventive actions.
  • Learn to disposition non-conforming material using quality tools and develop knowledge of manufacturing practices and procedures.
  • Assist Engineering in researching and validating changes in processes, equipment, and test methods to improve yield or reduce cycle time according to established procedures.
  • Support process development during new product introduction by providing input on traceability, inspection requirements, and statistical process control criteria; develop manufacturing instructions, training sheets, and certifications; train operators on processes and engineering changes; and conduct operator certification on-the-job training and testing.
  • Assist Engineering with qualification and validation studies and reports by collecting, compiling, measuring, organizing, and recording data, writing procedures, and potentially maintaining a laboratory notebook.
  • Audit manufacturing and related areas for compliance with internal procedures, review findings for compliance risks and systems issues, prepare and administer audit-finding reports, and participate in post-audit conferences.
  • Evaluate corrective action plans for applicability and effectiveness.
  • Release the final Process Monitor for products prior to distribution.

About the Company

Boston Scientific

Medical devices maker for interventional specialties

Boston Scientific designs and makes medical devices used in procedures across cardiology, endoscopy, urology, and neuromodulation. Its products help doctors diagnose and treat conditions by guiding minimally invasive interventions and delivering therapies inside the body, with revenue from hospitals and clinics. The firm differentiates itself through a broad, global portfolio and heavy ongoing investment in research and development to expand capabilities and address complex health issues. Its goal is to improve patient care by providing reliable, effective medical devices and solutions that enable clinicians to perform safer, more effective procedures while growing its business.

Company size
10,001+
Company stage
IPO
Headquarters
Marlborough, MA
Founded
1979

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