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Boston Scientific

Medical devices maker for interventional specialties

Quality Engineer 2

Quality EngineeringPosted on Nov 10
Full-timeArden Hills, MN, USA

About the Job

Requirements

  • A Bachelor's degree in Engineering and a minimum of 2 years' experience, a master's degree in Engineering and a minimum of 1 year's experience, or an equivalent combination of STEM education and relevant work experience.
  • Strong data analysis skills using tools such as Excel and Minitab.

Responsibilities

  • Identify and implement effective process control systems to support the development, qualification, and ongoing manufacturing of products that meet or exceed internal and external requirements.
  • Support a culture of continuous improvement by driving enhancements to existing process controls.
  • Proactively investigate, identify, and implement best-in-class Quality Engineering practices.
  • Promote quality assurance, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
  • Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
  • Collaborate with production teams across all shifts to develop solutions that improve outgoing product quality.
  • Provide input to and implement departmental and cross-functional engineering initiatives.
  • Provide project direction, coaching, and mentoring to technician team members.
  • Ensure the development and execution of streamlined business systems that effectively identify and resolve quality issues.
  • Participate in team decision-making while demonstrating strong communication and collaborative problem-solving skills.
  • Influence cross-functional project plans, guide overall project strategy, determine when to solicit stakeholder feedback, and facilitate project decisions.
  • Collect and analyze process defect data, including scrap, nonconforming product, and customer complaints, to support product and process improvement efforts through appropriate analytical methods.
  • Lead initiatives to reduce and control manufacturing process defects by identifying root causes and implementing effective corrective and preventive actions.
  • Apply Six Sigma, statistical analysis, and Lean methodologies to investigate issues, improve processes, and enhance product quality.

Desired Qualifications

  • Experience with ISO 13485 standards.
  • Ability to work independently with minimal supervision.
  • Experience leading process improvement and corrective action initiatives.
  • Demonstrated project management success.
  • Experience working in a regulated industry.
  • Experience supporting New Product Introduction (NPI).

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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