Quality Manager

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.  

ESSENTIAL DUTIES & 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 

MINIMUM QUALIFICATIONS: 

To perform this position successfully, an individual must be able to perform each job duty satisfactorily.  The requirements listed below are representative of the knowledge, skills, and/or abilities required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. 

Required Education: 

• Bachelor’s Degree in engineering or other quality related technical field 

• ASQ Certified Quality Engineer a plus 

• Six Sigma Black Belt Training and/or Certification preferred 

Required Length & Type of Experience: 

• 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 

• Prior supervisory experience preferred 

Knowledge, Skills & Abilities (KSA’s):  

• 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 

PHYSICAL DEMANDS:  

The characteristics listed below are representative of the physical demands required by an individual to successfully perform the essential duties of this position.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. 

• 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. 

WORK ENVIRONMENT: 

The characteristics listed below are representative of the work environment typically encountered by an individual while performing the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. 

• 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. 

NOTE:  The above stated duties are intended to outline those functions typically performed by individuals assigned to this classification.  This description of duties is not intended to be all-inclusive or to limit the discretionary authority of supervisors to assign other tasks of similar nature or level of responsibility nor does it imply an employment agreement.