Description:
Contract-3-month assignment
The Location: onsite (no remote work)
Work Location: Onsite - Utah Facility
Number of Openings: 2 Positions
Position Summary
The Quality Documentation Specialist support the preparation, completion, and revision of nonconformance records using controlled Microsoft Word templates, previously approved examples, and manufacturing/quality data from authorized internal systems. This is a high-volume documentation execution role.
Essential Duties & Responsibilities
- Prepare and update nonconformance records using standardized Word templates and approved examples; adapt each record to its specific event rather than copying unverified content.
- Ensure an accurately documented problem descriptions, identified containment, scope of impact, part and lot numbers, quantities, and other required fields using verified source information and provided guidance.
- Navigate Oracle and other authorized systems to retrieve manufacturing orders, inventory, traceability, and quality information; cross-check entries for consistency.
- Identify missing, conflicting, or unclear information; proactively ask Quality, Manufacturing, Engineering, Production or other relevant personnel for clarification in person, by email, or through Teams.
- Incorporate reviewer comments quickly and accurately, manage revision cycles, and resubmit documents for review.
- Track assigned, in-progress, awaiting-input, and completed records; meet agreed productivity and quality expectations.
- Follow applicable documentation procedures, data integrity practices, and access controls; escalate issues rather than making unsupported assumptions.
Knowledge, Skills & Qualifications
- Strong Microsoft Word skills, including templates, tables, formatting, editing, and revision management; working knowledge of Excel, Outlook, and Teams.
- Ability to navigate ERP and other electronic systems and accurately transfer and reconcile information across sources.
- Excellent attention to detail, organizational skills, logical reasoning, and written communication.
- Comfortable performing repetitive, high-volume work with sustained accuracy and responsiveness to feedback.
- Proactive, approachable, and willing to walk to the appropriate department to resolve questions when necessary.
- Ability to follow defined instructions and work independently after training.
- General understanding of a plastic component structure and role of product specifications
- Ability to become knowledgeable in departmental procedures, GMP''s, Specifications/Guidelines, product lines/processes and commodities
- Familiarity with the importance of clear documentation and guidelines governing medical devices.
- Strong verbal and written communication skills
- Experience in quality documentation, document control, manufacturing administration, or quality assurance support.
Education and Experience
- Associate degree or equivalent combination of education and relevant work experience required.
- Degree field is not required; candidates with backgrounds in quality, manufacturing, life sciences, business, technical disciplines, or related fields are encouraged to apply.
- 1+ years of experience in a quality, manufacturing, regulatory, compliance, documentation, or related operational environment.
- Experience reviewing, documenting, and processing quality or regulatory records preferred.
- Experience following established procedures, workflows, decision trees, or quality system requirements.
- Experience working in a regulated environment is preferred but not required.
Minimum Qualifications
Travel Requirements
- Typically requires travel less than 5% of the time
Physical Requirements and Work Environment
- This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets.
- While performing the duties of this job, the employee may be required to sit or stand for long periods of time.
- Must be able to occasionally move and lift objects of up to 25 pounds.
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Enable Skills-Based Hiring No Job Posting Description Comments
Additional Details
- Manager''s Requested : (No Value)
- Does the position allow for the worker to be virtual/remote? : Yes
- Shore Options Available for this Position : Onshore Only
- Critical Position? : No
- Professional References Required for this position? : No
- Driving Assignment? : No
- Hiring Manager Name : Reaves, Mia (mia.reaves)
- Job Posting Description Comments : TBD
- Select Shift &Schedule : Salt Lake City, UT|Mon-Fri|8:00AM-5:00PM
- Enter Shift Times : 8-5