Senior Manager, Quality

Our Values and Culture

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

Who We Are

Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEMs (original equipment manufacturers) to enhance the lives of patients worldwide. Working at Integer means you are part of a team passionately pursuing excellence in all that we do and always reaching for the next great achievement.

Job Description

The primary purpose of this role is to lead the manufacturing site or sites assigned to ensure they meet and continue to meet customer requirements while remaining in compliance with the associated quality management system policies and procedures. You will provide leadership for a team of Quality function professionals, including any combination of Quality Supervisors, Quality Engineers, and individual performers.

Responsibilities

• Provide leadership for a team of Quality function professionals
• Define and champion the evolution of the core elements of the local Quality System to standardize with the overarching Integer QMS
• Ensure the entirety of the local quality management system, including Management Review, CAPA, Complaint Handling, Document Change Management, Design Control, Production control, internal and Customer nonconformance management, Supplier Quality Audits, and Internal QMS Audits
• Serve as the management representative
• Adhere to company policies and procedures and all safety and quality requirements
• Prevent and correct quality-related gaps in existing processes and systems
• Drive process improvements required to enable the organization to execute at a more accurate and efficient level

Build & Develop Teams

• 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
• Establish a culture of quality amongst your team and across the site and/or business
• 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

Manufacturing Support

• Serve as a key interface, directly and regularly, with internal and external customers
• Contribute 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
• Manage the risk(s) associated with quality concerns
• Provide input into and manage your department budget, department strategic plans, and quality plans
• Ensure that rigorous root cause analyses have been initiated and/or completed

Support Site Quality Activities

• Exemplify Quality - "I own Quality"
• Champion the development of and deployment of the systems and tools to drive innovation and continuous improvement within the Quality Management System
• Perform other duties as needed and as directed by your manager

Support Non-Conforming Material Process

• Ensure that the investigation and disposition of non-conforming materials meet all necessary internal and customer requirements
• Lead and manage product complaint investigations
• Initiate and facilitate plant CAPA activities that result from the analysis of data from complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis

Provide Support of Integers Strategic Imperatives

• Embrace the Manufacturing Excellence culture based on the Integer Production System and its five focus areas
• Lead the implementation of sustained change by identifying opportunities to continuously improve our processes and products
• 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

How You Will Be Measured

• 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
• 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

What Sets You Apart

• Minimum education: You have earned, as a minimum, a bachelors degree in an engineering or related technical field. A masters 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.
• 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.
• Quality specific certifications such as Six Sigma Green Belt, ASQ Certified Manager of Quality, ASQ Quality Auditor, or other related certifications.
• 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.

Our Total Rewards Program

Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integers success. Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy. We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits. Parental leave is available after one year. Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity, and accident insurance. Employees are immediately eligible to participate in the 401(k) plan with company matching contributions. We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.

Equal Opportunity Employer

U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.