Supervisor, Quality

Integer Holdings · Santo Domingo

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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 will do in this role:

The primary purpose of this role is to be a functional leader within the quality organization. You will coordinate team deliverables provide daily direction to a team of quality professionals, including any combination of quality engineers and technicians, to ensure that quality requirements, performance goals and improvement objectives for a manufacturing site are achieved. Your primary focus will be on performance management and the growth, development, and performance of your direct reports in support of the QMS.

• 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 may lead efforts to identify potential gaps in existing processes and systems and to drive process improvements required to enable your department to execute at a more accurate and efficient level.

Build & develop teams:

• You will be supervising, coaching, and directing a team of quality professionals in support of one or more product lines or process areas within a manufacturing site.
• 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 are the first level support for resolving day-to-day issues as they are raised by members of your team and, after assessing the situation, you may seek cross functional and/or organizational support for resolution. To be successful, you will possess the technical understanding and the ability to apply procedures and concepts within your own discipline and basic knowledge of other disciplines.
• You will review and approve engineering change requests, nonconformance reports and engineering reports.
• As part of your responsibilities, you will establish daily/weekly/monthly objectives for your team members and ensure effective communications throughout the team. An element of these objectives includes providing active support for each of your direct reports to aspire to accomplish his/her Individual Development Plans as a roadmap to professional and personal skills development.
• You will drive an appropriate level of process control using a risk-based approach.
• You ensure compliance to the established Quality Management System.
• As an element of our belief that we all Own Quality, you engrain a culture of quality amongst your team.

Support Site Quality Activities:

• You embed Quality– “I own Quality.”  You are a standard bearer for Quality in everything we do at Integer, by assuring adherence to our Quality Management System (QMS), providing support to corrective and preventive actions investigation and implementation, and contributing to the successful attainment of our quality KPI’s and differentiated quality.
• You will apply standard data analysis practices and observe products and processes to establish root cause for product and process failures or to support the justification for improvements to products and processes.
• You will support internal & external quality audit activities, as applicable.
• 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 procedures and assure adequacy of corrective actions to prevent re-occurrence.
• You will lead and manage complaint investigations.
• You will participate in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
• You will apply standard data analysis practices and observe products and processes to establish root cause for product 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, and regular updates to QA RA weekly and monthly metrics.
  • Leadership of Sustained Change ensuring customer change notifications are initiated and completed, as necessary, and supporting continuous improvement activities as required.
  • Standardisation through workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs where applicable 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 adoption of standardized problem solving. methodologies, 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 production 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.
• You will have defined Goals and Objectives specifying key projects and expected milestones to achieve.
• Quality - Customer Direct Complaint Rate, NCR rate, Complaint Cycle Time, CAPA Cycle Time, Supplier Performance metrics
• Delivery – Achievement of scheduled tasks and milestones for assigned projects.
• Cost - Innovation and ideation are critical aspects of your role and you will be expected to generate continuous improvement suggestions and support the implementation of them.
• People – You play a key role in promoting Associate engagement. 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.
• Minimum experience:
  • 3 years of experience
• Specialized knowledge:
  • You have knowledge and experience with the specific product line or function you will support, such as manufacturing quality, supplier quality or quality engineering.
  • 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.

• Specialized skills
  • You understand what it means to lead, to take leadership actions, to create and share a coordinated vision, and to align a team to take on and resolve what needs to be done.
  • You possess a clear preference for working in a team environment and establishing an expectation that team comes before self.
  • You enjoy a fast paced and complex work environment, maintaining a calm demeanor that transcends the high energy, constantly changing manufacturing setting.
  • While you will have regular support and guidance from more experienced engineers, supervisors or managers, you will show the ability to work independently and collaboratively with other associates and cross-functional teams.
  • You demonstrate a solid technical aptitude with the ability to be an effective contributor to a team or produce results of a technical nature as an individual.
  • You demonstrate effective communication, both written and oral, & interpersonal skills.  You reflect a bias for action, decision making and applying your problem-solving skills.
  • You possess a positive, can-do attitude with an underlying belief that failure is not an option.

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

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