Quality Assurance Manager

4 weeks ago

Elk Grove Village, Illinois, United States ITW Full time
Job Description

This position reports to ITW Medical's Director, Quality Assurance & Regulatory and is responsible for Quality Assurance activities associated with the Hebron and Elk Grove Village, IL, sites. The individual will be responsible for compliance/certifications, complaints/corrective actions, and for the financial aspect of the quality function specifically tied to ownership of scrap and non-value-add activity reduction.

Key Responsibilities:
  • Customer-Facing Metrics (CFM) - Drive actions to improve performance to CFMs
    • On-Time Delivery - Ensure management of processes to help improve compliance to customer requested delivery dates and investigation of late deliveries to promote improvement.
    • Complaint Response Time - Works with Quality Team, Peers, and other Team Members to ensure complaints are properly investigated, acted upon and responded to in a timely manner.
    • Complaint PPM - Works with the Plant Management Team and other Team Members to reduce systematic contributors to defects and to ensure appropriate detection practices are implemented.
    • Scrap - Drives improvement in and motivates team member engagement to identify effective solutions for scrap reduction.
  • Compliance/Certification - Maintain the FDA QSR / ISO 13485 - compliant Quality Management System, including assignment of primary contacts and coordinating training support.
  • New/Change Product/Process Validation - Oversee management of validation activities, including ensuring appropriate protocols are written, identified actions are completed, and inclusive reports are written.
  • Complaint/Corrective Action Management - Act as direct contact (where appropriate) or manage contact (through Quality Engineers) for customer quality-related issues; coordinate course of action for alleviating and resolving concerns and providing timely responses.
  • Financial Management with Plant Management Teams and Reports for Process/Cost Control - Maintain product supply with minimum Scrap and NVA activities, and drive improvement by using data-based information to drive Scrap Reduction, elimination of NVA activities, and On-Time Delivery improvement.
  • Manage Department - Provides partnership with our First Teams to champion employee engagement efforts, manages talent acquisition and develops new hire onboarding plans as needed, and provides frequent performance feedback and completes annual reviews for the team.

Qualifications:

  • Bachelor's Degree Business Administration, Engineering or related field required, certification to internal auditing preferred.
  • 5-7 years Quality Management experience, with multi-site experience (with global cultural awareness), preferably in medical device, required.
  • Strong P&L Leadership, financial acumen.
  • Experience driving zero PPM in a lean manufacturing environment. Knowledge/experience with ISO 13485 and 21 CFR 820, or equivalent, quality system requirements required.
  • Ability to use MS Office Tools such as Word, Excel, Project (or other project management software), Access and MiniTab (or other statistics software).
  • Ability to build respect/trust within internal staff/other functional leaders as well as external customers.
  • Excellent interpersonal, communication (verbal and non-verbal), and presentation skills.
  • Possesses excellent time management, prioritization abilities, and strong project management skills.
  • Highly motivated, detail-oriented, and eager to drive needed change.
  • Demonstrated ability to autonomously make strategic decisions.
  • Must possess comprehension and reasoning skills used to understand and collect data, interpret technical instructions, and draw valid conclusions.
  • Ability to apply advanced mathematical concepts and theory such as geometry, statistics, algebra, calculus, and differential equations to address engineering issues.
  • Demonstrated ability to analyze data and make sound, enterprise-first, problem-solving decisions.
  • Ability to travel occasionally to other ITW locations and for customer visits.

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