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Manager, Quality Assurance

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Avanos

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Location:
United States , Lenexa

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

The Manager, Quality Assurance is responsible for overseeing the Quality Management System (QMS) as per ISO 13485 / FDA QSMR medical-device Regulation. In addition, this position is responsible for ensuring that the product quality is compliant with the customer requirements. This role provides day-to-day leadership of the quality function, ensures compliance with applicable standards and regulations, and partners with Plant Manager for product or process enhancements. The position is critical in supporting the site's ongoing operational expansion—from single-shift to multi-shift production—while preserving product quality, process control, and QMS integrity.

Job Responsibility:

  • Maintain, oversee, and continually improve the ISO 13485–compliant and FDA QSMR/QSR–compliant QMS
  • Develop, revise, and implement QMS procedures, work instructions, and controlled documents
  • Ensure QMS performance and control during operational expansion
  • Ensure product quality for sterile disposable medical products, including in-process inspections, final inspections, packaging operations, sterilization and environmental controls
  • Monitor and analyze quality trends across all shifts
  • drive investigations and corrective actions for nonconformances, scrap, and process deviations
  • Partner with Operations and Engineering to support validation and re-validation activities (IQ/OQ/PQ) and continuous improvement projects
  • Lead and direct sterilization compliance and performance
  • Lead and direct cross-functional evaluation of process and design changes
  • Lead and direct employee training programs
  • Lead and direct complaint handling, MDR evaluation support, and post-market surveillance activities
  • Own the CAPA system
  • Represent the company during ISO audits, FDA inspections and customer audits
  • Support and/or lead regulatory submissions (e.g., 510(k), letters to file) as needed
  • Lead and direct supplier qualification, auditing, SCARs, performance monitoring, and quality agreements
  • Establish and track site quality metrics, objectives, and dashboards aligned to company goals
  • Prepare and present QMS performance and quality data during Management Reviews
  • Lead and develop Quality Technicians, Inspectors, and support roles across multiple shifts
  • Serve as the site Management Representative for QMS compliance

Requirements:

  • Minimum 5–7 years in a regulated manufacturing industry (medical device, pharma, biotech, or similar)
  • Bachelor’s degree in engineering, Quality, Life Sciences, or related field
  • Hands-on experience maintaining product quality and QMS performance while expanding a manufacturing operation from one shift to two (or similar multi-shift expansion)
  • Deep knowledge of FDA QSR/QSMR, ISO 13485, and medical-device quality principles
  • Proven experience managing audits (FDA, ISO, customers) and regulatory compliance activities
  • Strong background in complaint handling, CAPA, nonconformance management, and quality metrics
  • Experience supporting or managing validations (IQ/OQ/PQ)
  • Demonstrated ability to lead and develop quality teams
  • Excellent written and verbal communication skills

Nice to have:

  • Experience with disposable medical devices manufacturing or sterile packaging
  • Supplier quality audit experience (lead auditor certification a plus)
  • Experience with process improvement methodologies (Lean, Six Sigma, etc.)
What we offer:
  • comprehensive and competitive range of benefits
  • generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting
  • benefits on day 1
  • free onsite gym
  • onsite cafeteria
  • uncapped sales commissions

Additional Information:

Job Posted:
January 30, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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