Senior Director, Quality

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 are we?

Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEM’s (original equipment manufacturers) to enhance the lives of patients worldwide and a provider of high-end niche batteries for specialized applications in the energy, military, and environmental markets. We are guided by our six Values, including focus on Customers, Innovation, Collaboration, Inclusion, Candor, and Integrity. 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.

What you’ll do in this role:

The primary purpose of this role is to provide strategic leadership to a number of CRMN sites in the US & LATAM regions 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 serve as a leader and key partner on all aspects of Quality to a team of site based Quality leaders, including any combination of Quality Directors, Senior Managers, Managers, Supervisors, Quality Engineers, and individual performers.  You will define and champion the evolution of the core elements of the local Quality System to standardize with the overarching Integer QMS.  You are responsible for the entirety of the local quality management system which includes 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 role may also serve as the management representative, Person Responsible for Regulatory Compliance (PRRC) and other similar roles as required. You may lead the execution of enterprise quality initiatives and promote and reinforce a culture of quality across the enterprise, business, and site.   You will also serve as a principal liaison for escalated contacts between Integer and customers involving quality matters associated with a product or product line as well as quality management system issues in your region.

• You will adhere to Integer Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements. You are accountable for preventing and 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:

• One of your primary responsibilities will be to lead your direct reports, which include any combination of Quality Senior Managers, managers, supervisors and other quality, regulatory affairs and engineering professionals. As such, you will champion talent development within the quality organization by leveraging individual growth and development plans and organizational succession plans.
• 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
• Other duties may be assigned.

Manufacturing Support:

• You serve as a key interface, directly and regularly, with internal and external customers, including regulatory agencies.
• 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 for which you are assigned.
• Proactively, you manage the risk(s) associated with quality concerns.
• You provide input to and manage the department budget, department strategic plans and quality plans. 
• You are the functional level support to your team ensuring that rigorous root cause analyses have been initiated and/or completed.
• Based on your assessment of a specific situation, you may recommend and coordinate cross 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

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 Change by identifying opportunities to continuously improve our processes and products and ensuring implementation of such changes comply with all customer contractual obligations and regulatory requirements.
  • Standardization through 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 Engagement promoted through the 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 will be an active supporter of the Integer Environmental, Health & Safety programs and the specific behavior-based safety programs active at your site.
• You will have defined Goals and Objectives specifying key projects and expected milestones to achieve.
  • Quality metrics that your performance directly impacts:  Customer Complaint Rate, NCR rate, Complaint Cycle Time, CAPA Cycle Time, Supplier Performance metrics, Regulatory performance metrics
  • Compliance to applicable regulations : Positive outcomes for regulatory audits, completion of required product approvals, licenses, regulatory requests and other regulatory affairs related activities on time and of high standard. 
  • Delivery on time and in full for acknowledged customer shipments supported by ensuring sites are meeting NCR cycle time targets and completing other tasks/projects in a timely manner where delays could impact customer deliveries.
  • Cost – Innovation and ideation are critical aspects of your role and you will be expected to lead your team in generating continuous improvement suggestions and supporting the implementation of them.
  • People- As a director, 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 a quality engineering or related technical field. A master’s degree is preferred.
• Preferably, you are an ASQ Certified Quality Manager and/or Engineer and you have completed the Six Sigma Black Belt certification program or equivalent. You have either received an advanced Degree in Regulatory Affairs or have taken and passed the Regulatory Affairs Certification (RAC)

• Minimum experience:

• You will have a minimum of 15 years of experience, including at least 10 years of management experience in a healthcare or other regulated manufacturing environment.

• You will have/had in a previous role multi-site responsibility

• Specialized knowledge

• You will have specialized knowledge in 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 are recognized as a key resource for consulting on statistical concepts including Design of Experiments, Capability Studies, Validations and risk assessment.
• You will have extensive knowledge and experience with product development, design verification, validation and risk management, coupled with in-depth Quality Management System knowledge and experience.
• You have knowledge in gaining and keeping product approvals and maintaining a quality system at a level applicable to high-risk devices

• Specialized skills

• You display a great ability for critical thinking and problem solving, with demonstrated capabilities transitioning from abstract to concrete concepts.
• In your tool kit of leadership skills, you are aware of the concept of Emotional Intelligence and you are able to share examples of your strengths as a people-developer.
• You enjoy a fast-paced and complex work environment in which you are comfortable and able to make timely decisions based on, at times, limited data.
• You maintain a calm demeanor that transcends the high energy, constantly changing production environment.
• You possess a positive, can-do attitude with an underlying belief that failure is not an option.
• While not required for this position, your willingness to consider relocation opportunities and rotational assignments will provide additional opportunities for future career growth and progression within Integer
• You remain actively engaged in your chosen or related discipline by staying up to date on new technologies, recent developments, and evolving learnings as they relate to your business or product line(s).  You may hold an active membership in a related professional society.
• You have demonstrable skills writing reports, business correspondence and procedure manuals developed through previous personal hands-on experiences drafting, editing, and finalizing such documents.
• You are proficient in reviewing, reading, analysing, and interpreting general business periodicals, professional journals, technical procedures, and governmental regulations.

• Travel: This position may require 25% or more of your time traveling domestically and internationally to Integer manufacturing sites, customer sites, and supplier sites, as required. As such, you have a current passport and are able to secure appropriate visas, as required, for travel to international locations as specified.

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