QA Specialist
DESCRIPTION:
Work effectively with CAPA Process Owners to determine root cause(s), formulate and document suitable corrective and preventive actions, determine appropriate effectiveness checks, escalate issues to CAPAs if appropriate, and facilitate CAPAs to ensure that they are closed in a timely manner. Generate reports and metrics, and proactively keep RA/QA management abreast of emerging trends.
Conduct in-depth audits as assigned, in accordance with approved schedule. Ensure audit reports generated are timely, and responses received are adequate. Perform effectiveness checks as required to close identified noncompliances. Escalate issues to CAPAs as appropriate.
Monitor, trend, coordinate and analyze results from all sources of corrective/preventive action, and submit for Management Review on a periodic basis.
Revise Quality System documents as instructed to ensure compliance with applicable regulations.
Maintain current knowledge of FDA and applicable international policies and regulations that may affect the company's products and customers.
Participate in Quality System improvement initiatives, as assigned.
Conduct training as needed.
REQUIREMENTS:
BS in a scientific discipline.
ASQ Lead Quality Auditor certification (or an equivalent lead assessor certification) is desired
Two plus years’ experience in a quality or compliance role in medical device and preferably IVD companies with working knowledge of the regulations
Strong attention to details and adherence to ABAXIS procedures.
Collaboration: Be able to work effectively across functional groups and various levels within the organization to achieve positive results.
Communication: Demonstrate active listening through full attention and respond appropriately. Be able to present verbal and written information clearly.
Planning/Organizing: Prioritize and plan work activities; using time efficiently. Demonstrate ability to multi-task keeping company objectives and compliance risk in mind.
Dependability: Take ownership and responsibility for assigned actions. Complete tasks on time to keep commitments, or notify appropriate person(s) with an alternative plan.
Adaptability: Adapt to change in the work environment, and demonstrate flexibility.
Professional Behavior: Treat people with respect, work with integrity and uphold company values.
Maintain professional behavior under all circumstances.
Computer: Working knowledge and experience in basic computer programs such as Microsoft Word, PowerPoint, Visio, Excel and Outlook.
Please apply on-line at: www.abaxis.com
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ABAXIS IS AN EQUAL OPPORTUNITY EMPLOYER
Abaxis is a Federal Contractor and requests priority referrals for Veterans and Individuals with Disabilities.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability
