- Manages, publishes, 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.
- Processes changes to company-wide QMS documents, including initiating redlines, assigning document numbers, submitting changes, for approval and gaining approval.
- Ensures that documents are approved in a timely manner and follows up with process owners, as needed.
- Releases approved controlled documents, ensures documents are posted at points of use, and notifies key stakeholders.
- Manages the document translation process with internal and external stakeholders, including requesting translations, coordinating review with internal stakeholders, and communicating feedback to external stakeholders.
- Controls external documents, including tracking such changes and coordinating change impact assessments with internal subject matter experts.
- Prepares reports and/or necessary documentation and provides to applicable stakeholders, both internal and external.
- 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 i n the Medical Device, Pharmaceutical, or equivalently controlled field.
- Specialized Knowledge:
- Proficient with computers, including Microsoft Word, Excel, PowerPoint, Outlook, Visio, SharePoint, and Teams.
- 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.
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Quality Systems Specialist I - Ireland - Integer Holdings Corporation
Description
Quality Systems Specialist I page is loaded
Quality Systems Specialist I
Apply locations Remote - Ireland time type Full time posted on Posted 2 Days Ago job requisition id R26022By 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
Accountabilities & Responsibilities:
What sets you apart:
U.S. Applicants: EOE/AA Disability/Veteran
About Us
Integer Holdings Corporation (NYSE:ITGR) is the largest medical device outsource (MDO) manufacturer in the world serving the cardiac, neuromodulation, orthopedics, vascular, advanced surgical and power solution markets. The company provides innovative, high quality medical technologies that enhance the lives of patients worldwide. In addition, it develops batteries for high-end niche applications in energy, military, and environmental markets. The company's brands include Greatbatch Medical, Lake Region Medical and Electrochem. Additional information is available at .
Integer is committed to equal opportunity for all, without regard to race, color, religion, creed, national origin, ancestry, ethnicity, sex (including pregnancy and gender), age, physical or mental disability, citizenship, veteran or military status past, current, or prospective service in the uniformed services, genetic information, sexual orientation, gender identity, marital status, or any other characteristic protected under applicable legally recognized protected basis under federal, state or local law. Greatbatch Integer complies with the Americans with Disabilities Act (ADA), as amended by the ADA Amendments Act, and all applicable state or local law. Consistent with those legal requirements, Integer will make reasonable accommodations for qualified individuals with a known physical or mental limitations of otherwise qualified employees and applicants with a disability if such accommodation would allow the individual to perform the essential functions of the job, unless the accommodation would impose an undue hardship on the operation of our business. If you are interested in applying for an employment opportunity and feel believe you need a reasonable accommodation pursuant to the ADA, please contact us at . All postings presume work will be performed entirely outside of Hawaii, California, Colorado, Maine, Connecticut, and Washington, and New York (where management is based outside of NY state)
To review the Integer U.S. Applicant Privacy Statement click here .
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