Manager, Quality

Integer • Full-time • Quakertown, PA • 2w ago

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

At Integer, our values are embedded in everything we do.

Customer

We focus on our customers’ success

Innovation

We create better solutions

Collaboration

We create success together

Inclusion

We always interact with others respectfully

Candor

We are open and honest with one another

Integrity

We do the right things and do things right

The primarypurpose of thisroleis to lead a manufacturing site to ensuretheymeet and continue to meetcustomerrequirementswhileremaining in compliance with the associatedquality management system policies and procedures. You willprovide leadership for a team of Quality functionprofessionals, includingany combination of Quality Supervisors, Quality Engineers, and individual performers. As a manager, youdefine and champion the evolution of the coreelements of the local Quality System to standardizewith the overarching Integer QMS. You are responsible for the local quality management system whichincludes but is not limited to Management Review, CAPA, Complaint Handling, Document Change Management, Design Control, Production control, internal and Customer nonconformance management, Supplier Quality Audits, and Internal QMS Audits. This rolealso serves as the management representative.

You adhere to company policies and procedures and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements as required within your location.

In addition, you are accountable for correcting potential quality related gaps in existing processes and systems and driving process improvements required to enable the organization to execute at a more accurate and efficient level.

Build & develop teams:

You lead, coach, and develop a team of quality professionals in support of one or more product lines or process areas within a design/manufacturing site or a business category.

As an element of our belief that we all Own Quality, you establish a culture of quality amongst your team and across the site and/or business and establish the expectation for compliance 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 accomplish the Individual Development Plans that 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 plan ensuring that the strategies for driving the Quality initiatives consistent with the journey to differentiated quality are specified and prioritized.

You are responsible for ensuring the completion of projects that are of the highest priority or highest visibility for our customers.

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

You managethe department budget, department strategic plans and quality plans.

You are the functional level support to your teamensuring that rigorous root cause analyses have been initiated and/or completed.

Based on your assessment of a specific situation, you may recommend and coordinatecross functional and/or organizational support to 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 exemplify Quality– “I own Quality.” You are a standard bearer for Quality in everything we do at Integer, contributing to the successful attainment of our quality Key Performance Indicators and journey to differentiated quality.

You champion the development of and deployment of the systems and tools to drive 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 the investigation and disposition of non-conforming materials meet all necessary internal and customer requirements and assure efficacy of corrective actions to prevent recurrence.

You will lead and manage product complaint investigations.

You will initiate and facilitate plant CAPA activities that result from the analysis 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 will establish root cause ofproduct and process failures to drive the appropriate improvement activities.

Provide support of Integer’s Strategic Imperatives:

You embrace the Manufacturing Excellence culture based on the Integer Production System and its five focus areas:

Strategy Alignment through 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 Changebyidentifying opportunities to continuously improve our processes and products and ensuring implementation of such changes comply with all customers contractual obligations and regulatory requirements.

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

Associate Engagementpromoted through collaborative problem solving, that includes working with associates at all levels of the organization, and through participation in behavior-based safety programs, and improvement idea and suggestion systems.

Systems & Process Optimization through adoption of principles of built-in quality, optimized scheduling & material system designs, work cell design, and total productive maintenance.

How you will 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; you are an active supporter of the Integer Environmental, Health & Safety programs.

You have defined Goals and Objectives specifying key projects and expected milestones to achieve.

Quality metrics that the site and/or business must achieve: Customer Complaint Rate, NCR rate, Complaint Cycle Time, CAPA Cycle Time, Supplier Performance metrics.

Delivery on time and in full for acknowledged customer shipments, particularly those that are directly impacted by the results of projects that your team is assigned to lead and deliver by specified milestones.

Cost – Innovation and ideation are critical aspects of your role, and you are expected 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 handled in 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 least 8 years of experience in a manufacturing environment in which ISO standards’ governance and/or regulatory compliance were expected.

You have prior supervisory or leadership experience.

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 have previous experiences applying procedures and concepts within your own discipline and basic knowledge of other disciplines.

You demonstrate the aptitude and interest in learning the details about new products, the processes for manufacturing such products, establishing the controls and governance procedures for maintaining consistency, and adhering to customers’ requirements.

Specialized skills:

You articulate a personal strategy for what it means to lead, to take leadership actions, to create and share a strategic vision, and to align a team to achieve 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 possess a positive, can-do attitude with an underlying belief that failure is not an option.

U.S. Applicants: EOE/AA Disability/Veteran

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