Quality Assurance Specialist

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Full Time Clerical Lompoc, CA, US

Salary Range: $66,037.00 To $90,802.00 Annually

Under general direction, will provide onsite support in quality systems activities to assist in meeting company objectives and quality systems requirements.

include the following. Other duties may be assigned.

• Assist Quality Management in establishing, implementing and maintaining the quality management system.
• Review daily feedback, including customer complaints, non-conforming reports, Supplier quality issues, etc., and assess the need for Corrective Actions, including CAPA, reporting to Regulatory Authorities, post market surveillance and risk mitigation update.
• Review, update and monitor quality systems documentation (i.e. quality plans, post market surveillance, etc.) and maintain corresponding logs.
• Summarize monthly customer feedback, quality related activities, coordinate with engineering and report findings to Quality Manager.
• Conduct internal quality audits.
• Coordinate calibration and environmental monitoring activities, summarize and report findings to Quality Manager.
• Verify quality documentation to ensure accuracy.
• Assist in the collaboration of production and quality control to resolve in-house quality concerns.
• Maintain work area in a clean and orderly fashion.
• Adhere to company and departmental policies and practices as well as ISO, safety, and security measures.

include the following. Other duties may be assigned.

• Continually look for ways to improve processes, procedures and/or products; evaluating and participating in improvements as appropriate.
• Occasional travel to attend training / meetings or conduct Internal /Supplier Audits, as needed.
• Generate reports and reconcile information.
• Provide accurate and complete information in a prompt manner.
• Other projects or tasks as assigned.

This position has no supervisory responsibilities.

Bachelor’s degree from a four‑year college or university in a scientific field and 2 to 4 years related experience. Previous medical device quality experience is desirable.

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, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the described functions.

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to complete forms accurately and write routine notes and documentation. Ability to effectively communicate information in one-on-one situations to other employees of the organization.

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 use word processing, spreadsheet, and database applications. Ability to learn various software programs.

None required.

Knowledge of FDA GMPs, ISO 13485, MDSAP

Knowledge of medical device manufacturing or a related field.

Ability to communicate effectively, orally and in writing, with employees of various disciplines within various departments and all other internal and external contacts.

Ability to be flexible in changing…