Quality Assurance Specialist

DenMat Holdings, LLC•Lompoc, CA

6d•$66,037 - $90,802•Onsite

About The Position

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

Requirements

Bachelor’s degree from a four-year college or university in a scientific field and 2 to 4 years related experience.
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.
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 daily workload priorities as directed and accurately perform detail- oriented work.
Ability to work independently and demonstrate strong organizational, follow-through and resolution skills.
Ability to maintain accuracy, consistency and quality in a fast-paced, multi-task environment.
Ability to coordinate and synchronize multiple projects.
Ability to function in a controlled environment under domestic and international regulations and handle extremely confidential data.
Regularly required to talk; hear; sit; use hands to finger and handle; bend at the waist and/or neck use one or both hands repetitively; use fine manipulation with one or both hands and to reach above or below shoulder level.
Occasionally required to stand; walk; twist at the waist or neck use a simple grasp with one or both hands; and lift and/or move up to 50 pounds.
Normal 20/20 vision ability (with corrective lenses, if needed) is required by this position.

Nice To Haves

Previous medical device quality experience is desirable.

Responsibilities

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.
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.