Manager, Quality Systems (Mat Leave Cover - 12 months)

Posted 4 Days Ago
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Hiring Remotely in Ireland
Remote
Senior level
Healthtech • Manufacturing
The Role
The Manager of Quality Systems leads and develops a team of quality professionals, establishes a culture of quality, manages risk related to quality concerns, and ensures the implementation of quality initiatives. They interface with customers, perform assessments, and promote continuous improvement within the Quality Management System.
Summary Generated by Built In

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

Build & develop teams:

  • You lead, coach, and develop a team of quality professionals in support of the Integer Quality System and assessing systems within a 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 organisation 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 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.

Quality Engineering Support:

  • You serve as a key interface, directly and regularly, with internal and external customers.
  • You are a key contributor ensuring that the strategies for driving the Quality initiatives 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 (internal and external).
  • Proactively, you manage the risk(s) associated with quality concerns.
  • You are the 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.

Support Site Quality Activities:

  • You are responsible for the scheduling and implementation of the Integer PCAS process.
  • You will perform PCAS assessments on individual sites, provide a detailed report and support the site to root cause and implementation of corrective actions.
  • 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

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 — Achievement of Integer’s SAFE-T targets for engaged safety awareness and active involvement in supporting the implementation and sustaining of environmental, health, safety, and security initiatives.
  • Delivery — Achievement of scheduled tasks and milestones for assigned projects
  • Productivity — Achievement of committed results, completion of assigned projects
  • Quality – Achievement of Global Quality KPI’s
  • Cost Improvement — Cumulative incremental savings realized as a result of your accomplishments and collaboration, particularly in support of continuous improvements
  • Cost Controls — Adherence to budgets
  • Engagement – Promote Associate engagement and support each Associate’s Individual Development Plan; coach direct reports in support of their career plans and professional development and represent their interests in Talent and Succession Planning processes

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 5 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. 
    • You 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 have previous experiences applying procedures and concepts within your own discipline as well as 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

The Company
HQ: Plano, TX
2,909 Employees
On-site Workplace
Year Founded: 1940

What We Do

Integer Holdings Corporation (NYSE:ITGR) is a leader in advanced medical device outsourcing (MDO) and serves its customers by providing comprehensive end-to-end solutions with its unparalleled expertise in innovation and manufacturing. Integer's vision is to enhance the lives of patients worldwide by being its customer's partner of choice for innovative medical technologies and services. Additionally, through Electrochem, an Integer company, it develops custom batteries for high-end niche applications in energy, military, and environment markets. The company's medical device manufacturing brands include Greatbatch™ Medical and Lake Region Medical™. Additional information is available at www.integer.net.

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