Point of Care Blood Laboratory Systems, Anytime, Anywhere.
Abaxis is a pioneer in the development and commercialization of leading-edge innovative technology, tools and services that support best medical practices, enabling practitioners to respond to the health needs of their patients, while operating economical and profitable practices, at the point of care.
Abaxis Inc, a manufacturer of blood point-of-care diagnostic systems based out of Union City, is seeking qualified candidates for the following role:
DESCRIPTION:
- Manage the Complaint Handling function, ensuring that complaints are processed in a uniform and timely manner.
- Work effectively with complaint investigators to determine root cause(s), formulate suitable corrective and preventive actions, determine appropriate effectiveness checks, and escalating issues to CAPAs if appropriate. Support with ensuring CAPAs are adequately documented and closed in a timely manner.
- Monitor, trend and analyze results from worldwide complaints for both Medical and Veterinary products. Keep senior RA/QA management and other appropriate function management abreast of emerging trends.
- Manage Recalls through closure.
- Work with international regulatory bodies to communicate and address complaints, including EU Vigilance.
- Submit metrics for Management Review with proposed solutions to any identified issues or trends.
- Manage the company’s EH&S program. Effectively implement and administer the elementsof the Safety Program including, Injury Illness & Prevention, Exposure Control, Hazardous Communication, BioSafety, Chemical Hygiene, General Safety, Ergonomics, etc.
- Support with Internal Audits, and ensure in-depth audits are conducted in accordance with approved schedules. Ensure audit reports generated are timely, and responses received are timely and adequate. Verify closure to corrective/preventive actions, and maintain files in current status
- Provide/Develop GMP Trainings as necessary.
- Write, facilitate the development of, and approve Quality System documents to ensure compliance with applicable regulations, while incorporating industry best practices.
- Review and approve Quality System documents, Deviation Reports.
- Ensure compliance with applicable regulatory requirements for Complaint handling, employing industry best practices.
- Maintain current and in-depth 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.
REQUIREMENTS:
- BS in Engineering, Chemistry, or other relevant scientific discipline or relevant experience.
- SixSigma/Lean Manufacturing training and experience highly desirable.
- Lead Assessor certification preferred.
- Ten plus years experience in a senior compliance role in IVD/medical device companies.
- Strong attention to details.
- Management: Empower and enable staff to perform optimally. Ability to lead and facilitate projects to conclusion.
- Sense of Urgency: Demonstrate appropriate sense of urgency with regards to responsiveness with addressing any high risk compliance issues, and manage compliance risk proactively.
- Collaboration: Be able to work effectively across functional groups and various levels within the organization to achieve positive results.
- Judgment: Exhibit sound and accurate judgment; providing reasoning for decisions.
- Communication: Demonstrate active listening through full attention. Read analyses and reports, interpret technical procedures and government regulations, write reports, business correspondence and procedures. Disseminate knowledge and information on regulations utilizing appropriate media with strong verbal, non-verbal and written skills.
- Planning/Organizing: Prioritize and plan work activities; using time efficiently; plan for additional resources; set goals and objectives; organize and schedule tasks for direct reports and develop realistic action plans. Demonstrate ability to multi-task keeping company objectives and compliance risk in mind.
- Problem Solving: Demonstrate solid analytical skills to define problems, compile data, establish facts, and draw valid conclusions. Identify and resolve problems in a timely manner; uses reason even when dealing with difficult or emotional topics. Must be resourceful.
- 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 changes 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 including in very difficult situations.
- Computer: Working knowledge and experience in basic computer programs such as Microsoft Word, PowerPoint, Visio, Excel, Outlook and Microsoft Project.
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.
