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Form of workPosition Summary
The Quality Technician will be responsible for maintaining our corporate quality systems while providing quality assurance support to operations. The qualified candidate will perform complaint investigations on non-returned devices, coordinate the Calibration and Preventive Maintenance Program, and provide administration activities on the company training system. Additional duties include conducting Quality Holds, Non-Conformance Report evaluations, approving labels, and revising Basic Operating Procedures (BOP'S).
This is an onsite role located at our Salt Lake City, UT manufacturing plant.
Essential Duties & Responsibilities
Coordination of NC & CAPA processes:
- Supports NC and CAPA activities as needed (Initiation and follow up to comply with suitable requirements).
- Utilize technical background to perform materials nonconformance evaluations.
- Solve quality problems and/or investigations in order to identify root cause and implement effective solutions. Corrective and preventive actions for quality systems and customer complaints.
Administration of Site Training:
- Provides visibility of pending training.
- Weekly tracking of on-time training.
- Maintaining employees training (inactivating / activating employees, updating training plans).
- Provides training Metrics to support Quality Key Performance Indicators, Operational Reviews and Quality Management Reviews.
Performs Product Complaint Investigations on non-returned devices:
- Perform PCI activities for NA Notifications at the US Regional Service Center as needed
Oversight of Quality Holds Process:
- Initiation, Submission, Tracking and Release
Maintain Calibration Program updated:
- Ensuring equipment is sent out to vendors for calibration per the defined schedule.
Administration of Planned Process Deviations (PPD):
- Maintains PPD records for the US Region.
- Assigns PPD numbers.
- Ensures the PPDs have the required evidence of training.
- Makes sure PPDs are not used past due expiration date.
Performs FAI, IQ activities and limited release
Provides ad hoc Quality support to Operation daily activities.
Works on special projects as they arise.
Knowledge & Skills
Exceptional organizational skills, demonstrated ability to analyze, sort and retrieve information efficiently and quickly.
Ability to work in a fast-paced environment and multi-task.
Must be capable of organizing data from multiple sources, extracting key information and
writing technical reports.
Exceptional communication skills required in order to collaborate effectively with cross functional teams.
Strong analytical and problem-solving skills and familiarity with GxP practices.
Intermediate working knowledge of Excel (pivot table, filtering, graphics), Word & PowerPoint.
Knowledge of basic statistical techniques is a plus.
Working knowledge of FDA and ISO 13485-2016, ISO 14971 and 21 CFR is preferred.
Experience with Class II medical device preferred.
Strong interpersonal skills and adept at communication with employees at all levels within the organization
Minimum Qualifications, Education & Experience
High School diploma or GED equivalent
Bachelor's degree in technical/scientific field from an accredited college or university is preferred or equivalent practical experience.
1-2 years' experience in medical device quality environment preferred.
Medical device operations experience and/or knowledge is a plus.
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.
