Quality Systems Eng II- Remote Ireland
Integer Holdings Corporation
- Ireland
- Permanent
- Full-time
- 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.
- 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.