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| add to favorites | SUPERVISOR PRODUCT SAFETY, COMPLAINT CLOSURE | No Picture |
| At Abbott, every day is filled with new discoveries and leading-edge innovation. Our professionals are passionate about life, health care and their contributions. With almost $26 billion in sales in more than 130 countries, we’re not just poised to enhance the health of the world – we’re positioned to make it happen. SUPERVISOR PRODUCT SAFETY, COMPLAINT CLOSURE Job ID 76437BR Santa Ana, CA Manages and coordinates activities of employees engaged in the complaint handling and adverse event reporting process. In addition, may be required at times to complete these tasks. In addition to supervising complaint closure, provide quality assurance leadership with product quality data and complaint trending to drive product improvements and corrective and preventive actions. In conjunction with corporate QA, assists in field actions (including product recalls) as required. Prepare or assist department leadership with monthly trending reports, annual post-market surveillance reports and other monthly and quarterly reports. Participate in various process improvement projects. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising and managing performance; addressing complaints and resolving problems. May manage both non-exempt and exempt associates. Responsible for managing the quality processes related to AMO post-market product complaints, reporting on trends, driving corrective actions and ensuring compliance to all applicable corporate and divisional policies and procedures. Demonstrates thorough understanding of quality management standards as outlined in Good Manufacturing Practices (GMPs), FDA Code of Federal Regulations (CFRs) and ISO 13485 QUALIFICATIONS: Basic Qualifications: • 8+ years in medical device and/or pharmaceutical industry in quality and compliance • One to three years of supervisory experience • Experience interpreting MDR regulations, filing MDRs and communicating with FDA personnel regarding MDRs • Strong people management skills • Excellent verbal and written communication skills • Past experience with notified bodies/FDA and ability to interact appropriately and authoritatively during the course of a facility level inspection • Thorough knowledge of FDA/GMP/ISO requirements and regulations, with particular emphasis on complaint handling and adverse event reporting • Ability to work well and create a team environment Preferred Qualifications: • Excellent trainer of QS/complaint handling elements • Demonstrated internal and external auditing experience Abbott offers a comprehensive salary and benefit package. Qualified candidates may apply by posting their resume to www.abbott.com/careers. Reference number: 76437BR. Abbott provides a "smoke-free" work environment. Apply to URL: http://track.jobviper.com/ViewJob.asp?id=666767-1871-6653 www.abbott.com/careers An EOE, we are committed to employee diversity. |
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| add to favorites | SR. PRODUCT SAFETY ANALYST, COMPLAINT CLOSURE | No Picture |
| At Abbott, every day is filled with new discoveries and leading-edge innovation. Our professionals are passionate about life, health care and their contributions. With almost $26 billion in sales in more than 130 countries, we’re not just poised to enhance the health of the world – we’re positioned to make it happen. SR. PRODUCT SAFETY ANALYST, COMPLAINT CLOSURE Job ID 76430BR Santa Ana, CA Reviews complaint records prior to closure to ensure records are accurate, complete and compliant with all relevant requirements. Reviews complaints for potentially reportable AE status, including evaluation and follow-up regarding MDR reporting. Completes MDR reports within regulatory timelines. Communicates with US FDA regarding individual complaints, as required. Escalates significant issues to QA management as needed. Coordinates corrective actions with AMO manufacturing sites to resolve complaint root causes and prevent recurrence. Manages individual complaints on various AMO product lines, from opening to closing. Performs accurate and timely data entry in corporate complaint database. Coordinates complaint investigations, including determining investigation strategies, as needed with internal and external resources. Communicates directly with AMO customers regarding reported complaints and resolutions. Receives, documents, follows up and closes product complaints as reported from various sources. Assesses individual complaints for adverse event reporting requirements according to US FDA regulations for medical devices and drugs. Writes reports as needed. Analyzes complaint data for trends, and reports on trends to department management and other personnel. Will work with other departments on known and emerging issues to resolve quality problems. Reviews complaint records prior to closing to ensure compliant, accurate, and complete records. QUALIFICATIONS: Basic Qualifications: • 6+ years in medical device and/or pharmaceutical industry • Experience interpreting MDR regulations, filing MDRs and communicating with FDA personnel regarding MDRs • Good understanding of database management of complaint records • Proficient computer skills in Excel and Word • Excellent written and oral communication skills Preferred Qualifications: • Previous experience interpreting medical records or documents • Internal auditing experience • Interaction with FDA Investigators a plus • Regulatory affairs experience a plus Abbott offers a comprehensive salary and benefit package. Qualified candidates may apply by posting their resume to www.abbott.com/careers. Reference number: 76430BR. Abbott provides a "smoke-free" work environment. Apply to URL: http://track.jobviper.com/ViewJob.asp?id=666285-1871-8953 www.abbott.com/careers An EOE, we are committed to employee diversity. |
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