Abbott Senior Quality Professional in Santa Clara, California
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Responsible for ensuring the adequacy of the organization CAPA system to regulations. Root cause analysis and problem-solving expert and trainer. Works with quality management and senior management to ensure CAPAs are resourced and executed in a timely manner. Knowledge and experience with TRACKWISE software system. Works closely with other departments including but not limited to Operations, Complaint Handling, Marketing, Supply Chain, and Customer Service to resolve quality related issues to ensure Quality compliance and the safety and performance of Abbott Hematology distributed products.
Experienced Quality professional with, FDA Quality Systems Regulations -21 CFR Part 820, MDSAP, and ISO 13485 and ISO 14971 experience.
• Trains employees on CAPA execution and methodology including proper root cause analysis and problem definition.
• Identifies, documents, and initiates CAPAs with the CAPA board.
• Provide guidance to inspected parties regarding the completion of inspection corrective and preventative action plans (CAPAs).
• Assist with internal audits and prepares and maintains monthly CAPA Review Meetings.
• Provide CAPA metric update for management review and other key management meetings.
• Track status of CAPAs and report overdue CAPAs to management.
• Implement, coordinate and continuously review CAPA system, including interface with the management team on potential system and software program improvements.
• Assess and improve consistency, quality and timeliness of CAPA execution through implementing and maintaining effective CAPA monitoring systems and review mechanisms.
• Coordinate scheduling and logistics for inspection related activities.
• Collaborate with other functional areas for activities related to inspection preparation and prepares relevant materials and conduct inspection related training.
• Participate in health authority inspections and help to ensure that roles and responsibilities are defined and assigned for each inspection.
• Monitor trend in health authority inspection activities to proactively identify potential area of risk for the company.
• Coordinate in management review meetings and quality council meetings.
• Create, maintain, and communicate meeting minutes, agenda, attendance sheet, presentations and action items from the management review and quality council.
• Writes and/or assists in writing new SOPs or revising existing SOPs as required and, assists in the implementation/training of those new or revised documents.
• Issues monthly reports to the site management as requested.
Apprenticeship or Bachelor’s degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience.
At least 5 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.
Preferred experience in the Healthcare industry.
Has a history of completing successful projects and driving positive compliance outcomes.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org