The Quality Control Technician is responsible for Quality Control activities, including the inspection of incoming and in-process materials, as well as final inspection of medical products, deviations, nonconforming material reports, corrective and preventive action, and non-conformance investigation. May participate in internal/external audits as needed.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Familiar with GMP and ISO standards for medical devices
- Performs incoming, in-process, and final inspection activities
- Conducts Quality Systems tracking and trending for assigned areas
- May conduct product release activities per company procedures
- Performs task-related recordkeeping activities required to meet company and regulatory standards
- Reviews product test-records and associated certificate of analysis for accuracy and completeness
- Execute sampling plans by applying procedurally driven sampling methods
- Prepares reports by analyzing and summarizing data, and making recommendations
- Supports process validation activities as needed
- Supports regulatory inspections; may act as scribe for hosting inspections
- Conducts activities with a focus on compliance, effectiveness, and efficiency
- May assist with/conduct internal audits and associated corrections
- Completes required training in applicable procedures before conducting work in those areas
- Maintains professional and technical knowledge by attending workshops, seminars, reviewing professional publications, participating in professional societies, and maintaining professional certifications.
LOCATION: CP Medical
DEPARTMENT: Quality Control
REPORTS TO: Supervisor of QC
- High school diploma, or equivalent preferred
- Familiarity with medical product regulations (GMP and ISO) highly desirable
- Previous experience in Quality Systems, tests and measurements(metrology), assembly experience is desirable
- Effective at managing multiple priorities and timelines
- Ability to demonstrate professional demeanor under all conditions
- Strong team player; effective communicator; must able to work collaboratively with cross-functional areas
- Strong problem-solving skills; good decision making ability; must be able to provide solutions that are effective and compliant with procedural requirements
- Good verbal and writing skills; must be able to understand and revise procedures, records and other documents to meet company requirements; must be able to communicate effectively and act as a champion for quality
- Computerized systems; must be able to utilize various computing programs and applications effectively and efficiently.
- Ability to work overtime as workload dictates.
The job is typically performed under comfortable working conditions in an office, warehouse or clean room environment where light manufacturing is performed; any disagreeable elements are generally absent during normal performance of job.
This position has access to or may be exposed to confidential and proprietary Company information. Therefore, a high level of confidentiality must be maintained at all times with any Company information.
LIMITATIONS AND DISCLAIMER
The above position is meant to describe the general nature and level of work being performed; the Position description is not a comprehensive or exhaustive list of all duties, responsibilities or skills required for the position. Management has the right to assign or reassign duties and responsibilities to or from this position at any time.
To perform this position successfully, the employee must be able to satisfactorily perform each essential position duty and responsibility. All position requirements are subject to possible modification to reasonably accommodate individuals with disabilities.
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