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Integer Holdings Corporation

Medical device CDMO for cardiac devices

Quality Systems Engineer 3

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeChaska, MN, USANo salary listedIn-person

About the Job

Requirements

  • Earned at least a bachelor's degree in engineering or a related field; candidates who do not meet this education requirement may be considered with 10+ years of relevant experience.
  • Have 5+ years of progressive engineering and/or technically focused experience.
  • Have a strong technical and problem-solving foundation; training and certifications in problem-solving and project-management methodologies are preferred, including Six Sigma green belt minimum and black belt preferred.
  • Be able to observe, analyze, and develop solutions to challenging technical issues that produce measurable results in productivity, technical capabilities, capacities, or other competitive differentiators.
  • Work independently and collaboratively with cross-functional teams.
  • Demonstrate the ability to lead team activities and coach less experienced associates.
  • Have well-developed written and oral communication skills for communicating clearly and professionally at all levels of the organization.

Responsibilities

  • Select and apply standard quality-engineering techniques, procedures, and criteria to adapt and modify existing products and processes.
  • Lead cross-functional teams or projects with minimal resource requirements, risk, or complexity, and develop the skills to influence others toward goals.
  • Develop new approaches to challenging problems and work on projects that advance quality systems.
  • Originate procedures, work instructions, and reports to meet quality-system requirements, and review documentation from peers and others.
  • Perform technical project work using standard quality-management methodologies to investigate quality-process improvement opportunities.
  • Apply standard data-analysis practices and techniques to establish root cause for quality-system issues.
  • Support internal and external audits, regulatory inspections, and customer audits; support timely responses and closure of audit observations and findings; and review and maintain corrective actions from audit findings.
  • Assist in preparing, coordinating, and documenting the site's Quality Management Review.
  • Track and support customer notifications.
  • Provide Quality Systems and Compliance consulting related to CAPA, complaint investigations, and other compliance topics.
  • Support CAPA and NCR investigations to ensure timely and accurate processing.
  • Complete trending and evaluation of data for quality-system metrics.
  • Adhere to the Quality Management System, facilitate or contribute to corrective and preventive actions, and contribute to quality KPIs and the journey to 5 Sigma.
  • Assist with quality-assurance functions as directed by Quality Management and perform other duties as required.
  • Support Manufacturing Excellence and Market Focused Innovation strategies through site Hoshin plans, quality plans, validation master plans, quality-improvement imperatives, and regular updates to QA/RA weekly and monthly metrics.
  • Initiate and complete customer change notifications as necessary and support continuous-improvement activities.
  • Support standardization through workplace organization and visual controls (5S), Manufacturing Standard Work, and training and certification programs where applicable.
  • Promote associate engagement through standardized problem-solving methodologies, behavior-based safety programs, and improvement idea and suggestion systems.
  • Support systems and process optimization through adoption of built-in quality principles.
  • Actively support Integer Environmental, Health & Safety programs, adhere to Integer values, achieve defined goals and project milestones, and contribute to site quality KPIs and innovation.

Desired Qualifications

  • A master's degree may have been earned.
  • Training and certifications in problem-solving and project-management methodologies, including Six Sigma black belt.

About the Company

Integer Holdings Corporation

Medical device CDMO for cardiac devices

Integer Holdings Corporation is a large medical device CDMO that serves cardiac rhythm management, neuromodulation, and cardiovascular markets. It designs, develops, and manufactures device components and subassemblies through its brands Greatbatch Medical, Lake Region Medical, and Electrochem. The company differentiates itself by its scale, broad capabilities across multiple medical specialties, established brands, and global manufacturing footprint, enabling reliable supply for device makers. Its goal is to help medical device companies bring safe, effective technologies to market and improve patients’ lives worldwide.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Wilmington, DE
Founded
1940

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