Manager – Quality Engineering

Manager – Quality Engineering

Requirements

• Bachelor’s Degree in engineering or other quality related technical field
• Minimum 5 years experience in Quality Control/Assurance or similar technical capacity
• Internal quality system auditing experience for medical devices (ISO 13485) and US FDA Quality System Regulation (21 CFR 820) required
• Proficient in Microsoft Office (Excel, Word, Power Point, Outlook)
• Working knowledge of Minitab Statistical Analysis Software
• Strong analytical and problem-solving skills to resolve complex issues and handle multiple projects including statistical analysis and DOE

Responsibilities

• Provides Quality leadership and partner with site operations leader and/or General Manager to plan and drive quality objectives that accomplish business goals
• Positively represents the site and quality program through best-in-class customer service support to all customers with responsiveness and engagement resulting in Nordson MEDICAL being the customer’s supplier of choice
• Provides leadership and expert guidance in technical quality areas including quality engineering, product and process quality, and new product introduction
• Champions quality culture while driving improvements in operations on-time-delivery (OTD) and cost of poor quality (COPQ)
• Champions FOCUS Quality Operating System
• Prioritizes quality engineering and QC work requirements in accordance with production priorities and business needs to maintain efficient flow of product through QC checkpoints according to plan
• Ensures appropriate resources are assigned to execute the various projects, inspections and tests in compliance to the QMS to meet or exceed customer’s quality and delivery expectations
• Procures Inspection, Measurement & Test equipment and maintains calibration of this equipment
• Assesses quality engineering and QC team training needs and coordinates and/or delivers appropriate training, cross-training, and coaching
• Ensures all company policies, procedures, standards, and safe work practices are adhered to at all times
• Delivers a talent strategy that builds winning teams through a focus on empathy, integrity, inclusion, learning, and collaboration
• Promotes a culture consistent with Nordson values and Foundational Attributes
• Coaches for development and manages performance and behavior concerns in a timely manner
• Plans quality resources to reduce overhead costs and ensure allocation of resources to business priorities
• ISO and CFR management representative to the QMS with regular reporting to site General Manager and NM Corporate Quality on the status
• Recommends, leads, and drives improvements and lean initiatives for the QMS in support of increased efficiency, and achievement of business and compliance goals
• Liaison between Nordson MEDICAL and our customers in matters related to the QMS including and not limited to the timely execution of customer quality agreements; review of customer specifications; managing external customer audits, first article requests, validation requests, change requests, etc.
• Ensures compliance with all requirements of ISO 13485 and FDA’s CFR Part 820 (QSR), and any other applicable standards and regulations
• Manages the NC process including segregation of product, identification, investigation, documentation, and coordinating approval of disposition
• Leads assigned customer complaints and CAPA investigations
• Contributes to business goals through continuous improvement activities
• Develops and uses sampling techniques to determine results of testing
• Ensures DHR reviews are completed
• Establishes and maintains accurate record keeping norms to meet regulatory requirements for Good Documentation Practices (GDP)
• Communicates with customers as needed to support complaint investigations or new product development
• Supports new product development by developing inspection / test methods
• Supports internal, customer, and/or supplier audits as necessary
• Supports document control as a back-up as necessary
• Collaborates closely with other functions such as engineering, operations, etc. to execute QC tasks in accordance with site priorities and initiatives
• Promotes data driven decision making by ensuring required information is maintained in ERP system by the QC team and effectively reporting tiered metrics to site leadership team
• Performs other duties and responsibilities as assigned

Preferred Qualifications

• ASQ Certified Quality Engineer a plus
• Six Sigma Black Belt Training and/or Certification preferred
• Prior supervisory experience preferred