Quality Manager

GENERAL SUMMARY:

TheQualityEngineeringManagerisresponsibleforensuringproperexecutionofqualitypracticesforNordsonMEDICAL,directly leading the siteengineers,inspectors and team leads,andmaintainingadherence to required QMS practices.As the site quality representative,theCIQualityEngineeringManagerdemonstratesextensive knowledge of processes, products, and job specifications for the quality functions.Themanagerisresponsible forguiding, leading, and training direct reports, ensuring that they are carrying out activities in a manner that is consistentwith the Nordson policies and values. 

ESSENTIAL DUTIES & RESPONSIBILITIES:

• ProvidesQuality leadership and partner with siteoperations leader and/orGeneral Manager to plan and drive qualityobjectivesthataccomplishbusiness goals

• Positivelyrepresentsthe 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

• Providesleadership 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 ofpoor quality(COPQ)

• Champions FOCUS Quality Operating System

• Prioritizesquality engineering andQCworkrequirementsinaccordancewithproductionprioritiesandbusinessneeds tomaintainefficient flow of product through QC checkpoints according to plan  

• Ensuresappropriateresourcesareassignedtoexecutethevariousprojects,inspectionsandtests in compliance to the QMSto meet or exceed customer’s quality and delivery expectations

• Procures Inspection, Measurement & Test equipment andmaintainscalibration of this equipment

• Assessesquality engineering andQCteamtrainingneedsandcoordinatesand/ordeliversappropriatetraining,cross-training,andcoaching

• Ensuresallcompanypolicies,procedures,standards,andsafeworkpracticesareadheredtoatalltimes

• 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 concernsin 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 drivesimprovements 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 thetimelyexecution of customer quality agreements; review of customer specifications; managing external customer audits, first article requests, validation requests, change requests, etc. 

• Ensurescompliance 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 todetermineresults of testing

• Ensures DHR reviews are completed 

• EstablishesandmaintainsaccuraterecordkeepingnormstomeetregulatoryrequirementsforGoodDocumentationPractices(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 tasksin accordance withsite priorities and initiatives

• Promotes data driven decision making by ensuring required information ismaintainedin ERP system by the QC team and effectively reporting tiered metrics to site leadership team

• Performsotherdutiesandresponsibilitiesasassigned

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 engineeringor otherquality related technical field

• ASQ Certified Quality Engineer a plus

• Six Sigma Black Belt Training and/or Certification preferred

Required Length & Type of Experience:

• Minimum5years experience in QualityControl/Assuranceor 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 experiencepreferred

Knowledge, Skills & Abilities(KSA’s):

• Proficient in Microsoft Office (Excel, Word, Power Point, Outlook)

• Working knowledge of Minitab Statistical Analysis Software

• Strong analyticaland problem-solving skills to resolve complex issues and handle multiple projectsincluding statistical analysisand DOE

• Strong written and verbal communication skills to partner with engineers and other support staff clearly and concisely 

• Strongattentiontodetail

• Flexibilitytoworkinafast-pacedenvironmentwithchangingprioritiestomeetcustomerdemands

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.

• Employeemaybe requiredto remain stationary for extended periods of time.

• Employee maybe requiredto regularlylift upto 25lbs

• Employeemay occasionallybe requiredto transverse through office and/or manufacturing locations.

• Employeewillfrequentlybe requiredto actively listen and exchange information.

• Employeewillbe requiredtoobserveand assess information received via computer.

• Requires use ofcomputer,telephoneand operation of a motor vehicle.

WORK ENVIRONMENT:

The characteristics listed below are representative of the work environment typicallyencounteredby 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.

• Estimated20%travelrequired

• Must have reliable,appropriate transportation.

• Job requiresvisitation ofto variousNordsonand customer sites, which have varying environments/conditions, layouts, and accessibility.

NOTE: Theabove 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 ofresponsibilitynor does it imply an employment agreement.