QA/QC Technician

JOB SUMMARY:

The QA/QC Technician will be responsible for oversite of the calibration program, maintaining equipment records and performing document control activities. In addition, this position will be utilized to facilitate special projects as directed to advance the Quality Management System. You will play an instrumental role in the making sure all activities and documents have met all regulatory and compliance requirements.

JOB DUTIES:

• Maintain calibration records, Facilitate calibration with outside vendors per schedule, Interface with Service'Production'Lab to ensure calibrated equipment is identified, maintained, available and organized.

• Monitors performance of all aspects of the preventive maintenance (PM) program. Work to implement a viable PM program and update the program as operating conditions and other equipment running experience indicates. Adjusts PM Procedures and schedules as required to maximize performance and equipment longevity.

• Assisting in the implementation and release of change orders by ensuring training and documentation activities are successfully completed.

• Collect and maintain files of the latest revision level documentation necessary to define regulatory requirements.

• Provide documentation to all appropriate users and ensure that obsolete documentation is removed from distribution.

• Perform document control activities to ensure the Quality Management System is actively maintained and current.

• Perform clerical typing duties to generate documents as necessary.

• Ability to exercise independent judgement within defined procedures and practices to determine appropriate action.

• Ability to use logic to solve problems.

• Ability to provide guidance and training to company peers.

• Support with QC of both medical and non-medical devices manufactured and sold by CS Medical.

• Support with QA in complaint investigation and closure.

• Review and approve service generated documentation from the field and the depot.

• Conduct investigations and processes complaints in accordance with company SOP’s and regulatory requirements as requested.

• Perform in process quality control inspections and audits of materials, components, subassemblies and finished assemblies of medical devices as requested.

• Other duties and task may be assigned by supervisor, related to QC/QA activities, of CS Medical and the products and services offered.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

MINIMUM QUALIFICATIONS

• 2-year degree in technical or similar field
• Experience performing QC/QA activities in a quality system environment
• Familiarity with standard measurement equipment (i.e. micrometers, calipers)
• Excellent written and verbal communication skills
• Fluent in English (speaking, reading and writing)
• Excellent organizational skills
• Proficient with MS Office Suite (Word, Excel, Project, Access, PowerPoint, Visio)
• Relevant combinations of education, training and experience may be considered.

PREFERRED QUALIFICATIONS

• Bachelor's degree in science, engineering or technical field from an accredited college or university, or equivalent work experience
• Working knowledge of FDA medical device regulations, guidance documents, international standards (ISO 13485, 14971, 17025)
• Experience working with FDA regulated medical devices (Class II minimum)
• Experience developing SOPs, work instructions, Design History Files, Technical Files and other supporting documents to address domestic and international regulatory requirements.
• Experience working with an ERP system.

Accountabilities

• Calibrated Equipment is calibrated on-time, on a schedule, and available to service technicians and production personnel when needed.
• Special Projects assigned for Quality Assurance to support advancement of the eQMS are completed in a timely manner.
• Communication and relationship with other departments is one of mutual respect and cooperation.
• Change orders are implemented with proper post implementation tasks, training assignments and correctly referenced Documents of External Origin (DEO).
• Inspections are performed accurately and timely.
• Quality documentation is reviewed accurately and timely.
• The Quality Management System is improved over time.

LOCATION

This position will be based at our Creedmoor, NC office.

Terms of employment

This is a full-time, hourly, non-exempt position.

Hours

The general hours shall be Monday – Friday, 8:00am to 5:00pm with an hour break for lunch.

Work Environment

Work is regularly performed in office and warehouse environments.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is frequently required to sit. The employee is occasionally required to stand and/or walk. The employee must occasionally lift, carry, push or pull up to 40 pounds.

Travel

None required.

BENEFITS

Compensation package includes health insurance, dental insurance, vision insurance, Teladoc, life insurance and short-term disability. The Company also offers a 401k (both traditional and Roth options) with company contribution. The Company also offers paid time off and paid holidays. Employees can access the company’s employee assistance program. Benefits are subject to change.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.