Assist with the day-to-day operations associated with Control of Nonconforming Material, Corrective and Preventive Action (CAPA), and Internal Audits. Assist management to ensure that products, procedures, processes, contracts and services comply with applicable federal and state rules and regulations; as well as internal standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Physically quarantine nonconforming material. Perform electronic inventory transactions to prevent unintended use. Execute activities per approved material disposition. Update NCMR Log.
- Review CAPA documentation for completion of required deliverables.
- Assist with identification and organization of quality records associated with Nonconforming Material, CAPA and Internal Audits.
- Perform Internal Audits as a member of the Audit Team. Work with Audit Team to prepare audit reports. Track completion of audit responses and verify effectiveness of actions taken.
- Create training materials as necessary to communicate process requirements to user community.
- Conduct investigations into potential quality / compliance concerns. Keep management informed of issues.
- Perform other tasks as assigned to enable organizational and quality objectives to be met.
This job has no supervisory responsibilities.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Associate's degree (A. A.) or equivalent from two-year college or technical school. Bachelor’s degree (B. A.) in science, engineering, quality or other technical field from a four-year college or university preferred. One to two years experience working closely with or as part of a Quality Assurance or Compliance function in the medical device, pharmaceutical or other regulated industry preferred. Good understanding of QMS as applied to medical devices. Experience can substitute for degree requirements.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
CERTIFICATES, LICENSES, REGISTRATIONS
Quality System Auditor certification desired
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch or crawl; sit; walk; and talk or hear. The employee is occasionally required to stand. The employee must frequently lift or move up to 25 pounds.
Specific vision abilities required by this job include close vision, distant vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts. The noise level in the work environment is usually moderate.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled