Quality Manager

Nordson Corporation•Easton, PA

46d

About The Position

Nordson Medical, a global leader in Interventional Solutions, Fluid Components, and Surgical Solutions, is seeking an experienced and highly motivated individual to join our team. We are committed to creating a diverse and inclusive workplace, and we are looking for candidates who share that same commitment. Summary of the role As a member of our team, you will have the opportunity to work in a dynamic and collaborative environment, where your ideas and contributions will be valued and respected. GENERAL SUMMARY: The Quality Engineering Manager is responsible for ensuring proper execution of quality practices for Nordson MEDICAL, directly leading the site engineers, inspectors and team leads, and maintaining adherence to required QMS practices. As the site quality representative, the CI Quality Engineering Manager demonstrates extensive knowledge of processes, products, and job specifications for the quality functions. The manager is responsible for guiding, leading, and training direct reports, ensuring that they are carrying out activities in a manner that is consistent with the Nordson policies and values.

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
Strong written and verbal communication skills to partner with engineers and other support staff clearly and concisely
Strong attention to detail
Flexibility to work in a fast-paced environment with changing priorities to meet customer demands
Employee may be required to remain stationary for extended periods of time.
Employee may be required to regularly lift up to 25lbs
Employee may occasionally be required to transverse through office and/or manufacturing locations.
Employee will frequently be required to actively listen and exchange information.
Employee will be required to observe and assess information received via computer.
Requires use of computer, telephone and operation of a motor vehicle.
Estimated 20% travel required
Must have reliable, appropriate transportation.
Job requires visitation of to various Nordson and customer sites, which have varying environments/conditions, layouts, and accessibility.

Nice To Haves

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

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