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Hybrid Quality Systems Eng II- Remote Ireland Quality Systems Eng II- Remote Ireland

Integer Holdings Corporation · Ireland · Hybrid

About the job

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 position is to provide day to day support for key processes within the company-wide Quality Management System (QMS). As a Quality Systems Specialist, you will support the global Quality Systems team in maintaining established QMS processes and contributing to on-going improvement initiatives.

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.

Accountabilities & Responsibilities
  • Manages, and controls updates to company-wide Quality Management System documents while ensuring their accuracy, quality, and integrity.
  • Collaborates with cross-functional teams to support the development and approval of changes to the QMS.
  • Ensures company-wide document changes meet procedural requirements and submits feedback to owners, as needed.
  • Ensures that supplier quality documents are approved in a timely manner and follows up with process owners, as needed.
  • Provides Supplier Quality compliance guidance to Associates at the facilities.
  • Provides Supplier Quality Systems training orientation to new Associates. Updates orientation materials as needed.
  • Assists with quality assurance functions in support of needs directed by Quality Management.
  • Prepares reports and/or necessary documentation and provides to applicable stakeholders, both internal and external.
  • Provide metrics status to management for Supplier Quality related subjects.
  • Analyzes processes, procedures, data, risks, and work structure to create solutions for overall efficiency improvements.
  • Performs other duties as required.

What Sets You Apart
  • Minimum Education:
    •
    • Bachelor’s degree in a related field or combination of education and experience providing equivalent knowledge.
  • Minimum Experience:
    •
    • 5+ years of experience in the Medical Device, Pharmaceutical, or equivalently controlled field.
    • 2+ years Supplier Quality experience is desired.
  • Specialized Knowledge:
    •
    • Proficient with computers, including Microsoft Word, Excel, PowerPoint, Outlook, Visio, SharePoint, and Teams.
    • Strong understanding of applicable regulations and standards (21 CFR 803, 806, and 820, and ISO 13485). Problem Solving and training skills.
    • Familiarity with electronic QMS programs desired.
  • Special Skills:
    •
    • Highly organized.
    • Ability to perform and prioritize multiple tasks seamlessly and with strong attention to detail.
    • Excellent writing skills as well as interpersonal and communication skills.
    • Ability to work independently and as part of your team.
U.S. Applicants: EOE/AA Disability/Veteran