Offer summary

Qualifications:

Bachelor’s degree in a related field or equivalent experience., 5+ years of experience in the Medical Device, Pharmaceutical, or controlled field., Proficient in Microsoft Office Suite and familiar with electronic QMS programs., Strong organizational, writing, and communication skills..

Key responsabilities:

Manage and control updates to the Quality Management System documents.

Collaborate with cross-functional teams for QMS changes and ensure procedural compliance.

Release approved documents and manage the document translation process.

Prepare reports and analyze processes for efficiency improvements.

Job description

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

Accountabilities & Responsibilities:

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.

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.
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.