Manager, Quality - Integer Holdings Corporation

Theprimarypurposeofthisroleisto lead amanufacturingsite toensuretheymeetand continue tomeetcustomerrequirementswhileremainingin compliancewiththeassociatedqualitymanagement systempoliciesandprocedures.  Youwillprovideleadership for ateamof Qualityfunctionprofessionals,includinganycombination of QualitySupervisors, QualityEngineers, andindividualperformers.  As a manager,youdefineand champion theevolutionof thecoreelementsof the local Quality System tostandardizewiththeoverarchingInteger QMS.  You areresponsiblefor the localqualitymanagement systemwhichincludesbutisnotlimitedto ManagementReview, CAPA, Complaint Handling, Document Change Management, Design Control, Production control,internaland Customernonconformancemanagement, Supplier Quality Audits, andInternalQMS Audits.  Thisrolealsoservesas the managementrepresentative. 

• In addition, you are accountable for correcting potentialquality relatedgaps in existing processes and systems and driving process improvements required to enable the organization to execute at a moreaccurateand efficient level.  

Build & develop teams: 

• Youlead, coach, and developa team of quality professionals in support of one or more product lines or process areas within adesign/manufacturing siteora business category. 

• As an element of our belief that we all Own Quality, youestablisha culture of quality amongst your teamand across the site and/or businessandestablish the expectation forcompliance to the established Quality Management System. 

• You establish objectives for your team members, ensure effective communications throughout the team, and provide active support for each team member to aspire to accomplishtheIndividual Development Plansthat each one establishes as a means of professional skills development. 

• Your leadership style encourages teamwork, cross functional consensus building,and ensures accountability within your team and across the interactions your team members have with others inside and outside Integer. 

• You promote a diverse and inclusive work environment where your team feels supported and openly communicates opportunities and issues knowing they share a feeling of mutual trust. 

Manufacturing Support: 

• You serve as a key interface, directly and regularly, with internal and external customers.  

• You are a key contributor to the site or business Hoshin planensuring that the strategies for driving the Quality initiatives consistent with the journey todifferentiated qualityare specified and prioritized. 

• Youare responsible forensuring the completion ofprojects that are of the highest priority or highest visibility for our customers.  

• Proactively, you manage the risk(s) associated with quality concerns. 

• Youmanagethedepartment budget, department strategic plans and quality plans.  

• You are thefunctional levelsupportto your teamensuring that rigorous root cause analyses have been initiated and/or completed. 

• Based on your assessment of a specificsituation, you mayrecommend and coordinatecross functional and/or organizational supportto resolve an issue.  

• You promote a diverse and inclusive work environment where your team feels supported and openly communicates opportunities and issues knowing they share a feeling of mutual trust. 

Support Site Quality Activities: 

• You exemplifyQuality– “I own Quality.”  You are a standardbearer for Quality in everything we do at Integer,contributingtothe successful attainment of our quality KeyPerformanceIndicators and journey todifferentiated quality. 

• Youchampionthe development of anddeployment of the systems and tools todrive innovation and continuous improvement within the Quality Management System. 

• You may perform other duties as needed and as directed by your manager. 

Support Non-Conforming Material Process: 

• You will ensure that theinvestigation anddisposition of non-conforming materials meet all necessaryinternal and customer requirementsandassure efficacyof corrective actions to prevent recurrence. 

• You will lead and manageproductcomplaint investigations.  

• You willinitiate and facilitateplant CAPA activitiesthat result from theanalysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.  

• Through observation of processes and analysis of data, you willestablish root causeofproduct and process failurestodrivethe appropriateimprovement activities. 

Provide support ofInteger’sStrategic Imperatives: 

• You embracetheManufacturing Excellence culture based on the Integer Production System anditsfive focusareas: 

• Strategy Alignmentthrough Site Hoshin Plans,quality planning meetings,as Quality representative at site Plant Leadership team meetings, and through site all-hands communication meetings.  

• Leadership of Sustained Changebyidentifyingopportunities to continuously improve our processes and products andensuringimplementation of suchchangescomply withallcustomerscontractual obligations and regulatory requirements. 

• Standardizationthrough workplace organization & visualcontrols (5S), Manufacturing Standard Work, robust training &certificationprogramsand the adoption of Quality policies and procedures that are aligned to and harmonized with the enterprise (Integer) Quality Management System. 

• Associate Engagementpromoted throughcollaborativeproblem solving, that includes working with associates at all levels of the organization, andthrough participationinbehavior-basedsafety programs, and improvement idea and suggestion systems. 

• Systems & Process Optimizationthrough adoption of principles of built-inquality, optimized scheduling & material system designs, work cell design, and total productive maintenance. 

How youwill be measured:   

• The specific measures listed below may be subject to change and are not intended to be an all-inclusive list 

• Safety is our highest priority; youare anactive supporterof the Integer Environmental, Health & Safety programs. 

• Youhavedefined Goals and Objectives specifying key projects and expected milestones to achieve. 

• Quality metrics thatthe site and/or business must achieve: CustomerComplaint Rate, NCR rate, Complaint Cycle Time, CAPA Cycle Time, Supplier Performance metrics. 

• Delivery on time and in full for acknowledgedcustomer shipments, particularly those that aredirectly impacted by the results of projects thatyour team isassigned to lead and deliver by specified milestones. 

• Cost – Innovation and ideation are critical aspects of yourrole,and youareexpected to lead your team in generating continuous improvement suggestions and supporting the implementation of them. 

• People- As a manager, your key role is in promoting Associate engagement and supporting the professional growth and development of your direct reports.In your role, you will ensure that Associate Relations’ issues are handledin a timely manner. 

What sets you apart: 

• Minimum education 

• You have earned, as a minimum, a bachelor’s degree in an engineering or related technical field.  A master’s degree is preferred.  

• Minimum experience: 

• You have at least8years of experiencein a manufacturing environment in which ISO standards’ governance and/or regulatory compliance were expected. 

• You havepriorsupervisoryor leadershipexperience.   

• Specialized knowledge: 

• You possess the technical competence using and deploying such concepts as Root Cause Analysis, Problem Solving Skills, statistical analysis, and capability assessments.   

• We value your quality specific certifications such as Six Sigma Green Belt, ASQ Certified Manager of Quality, ASQ Certified Quality Engineer, ASQ Quality Auditor, or other related certifications 

• You have specialized knowledge with respect to the quality system regulations and standards important to the performance of this role e.g., EU MDR, ISO 13485, ISO 9001, Good Manufacturing Practices 21CFR820 and Good Documentation Practices along with auditing experience.  

• You have experience with development which includes authoring or supporting Test Method development (MSA, Gage RR, TMV, etc.), Product and process Validation Protocols/ Reports, risk assessments (pFMEAs,dFMEAs, etc.), Design of Experiments and Capability Analyses 

• You havepreviousexperiences applying procedures and concepts within your own discipline and basic knowledge of other disciplines. 

• You demonstrate theaptitude and interest in learning the details aboutnew products, the processesfor manufacturing such products, establishing the controls and governance procedures for maintaining consistency, andadhering tocustomers’requirements. 

• Specialized skills: 

• Youarticulate a personal strategy forwhat it means to lead, to take leadership actions, to create and sharea strategicvision, and to align a team toachieve that vision. 

• You have a tool kit of leadership skills aligned with Integer’s values.  

• You enjoy a fast-paced and complex work environment in which you must make decisions in a timely manner. 

• You maintain a calm demeanor that transcends the high energy, constantly changing production environment and customer landscape. 

• You possessapositive, can-do attitude with an underlying belief that failure is not an option.