Oct 15, 2019
Aesculap Inc. Aesculap Inc. QA Complaints Analyst II US-PA-Center Valley Job ID: 2019-15281 Type: Regular Full-Time # of Openings: 1 Category: Quality Aesculap Inc. Overview Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Through close collaboration with its customers, Aesculap provides advanced technologies for general surgery, neurosurgery and closure technologies. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver products and services that improve the quality of patients’ lives. Responsibilities Position Summary: The Quality Assurance Complaints Analyst II on the Post Market team will participate in complaint and MDR handling activities for the purpose of ensuring compliance with US and international regulatory compliance and medical device reporting requirements, as well as improving the customer experience. Responsibilities: Essential Duties Receive and process complaints escalated from internal and external customers related to products manufactured and or distributed and serviced by Aesculap in a manner consistent with all laws and regulations for medical devices. Evaluate and assess incoming complaints for adverse event reporting. Verifies decisions for “Vigilance report not required” determinations. Verifies comprehensive content of draft MDR reports prior to submission of Form 3500A to FDA for local and global affiliates, as necessary. Based on assessed risks, coordinates the escalation to Medical Reviewer(s) for decisions regarding the potential for serious injuries. Prepare and submit Medical Device Reports for submission to the FDA using eMDR (WebTrader and e-submitter) programs. Responds to FDA’s Request For Information (RFI) on any required MDRs Conduct follow up investigation on potential medical events including contacting hospital personnel Possess understanding of risk management concepts and is capable of assessing product risks. Identify critical product issues and escalate through the quality system for Field Action, Corrective and Preventive Action (CAPA), Supplier Corrective Action. Oversight of critical Post Market projects and routinely share project goals, status, requirements, and deliverables to management. Build key relationships with Product Managers to keep abreast of new technologies and product changes. Communicate, work cross-functionally and consult frequently with Manufacturing, Operations, Service, Sales, Research and Development, Regulatory and Marketing. Ensure completion of key deliverables. Must embody the Company’s Vision, Mission and Values Other duties may be assigned Expertise: Knowledge & Skills Secondary or peripheral job functions: Language Skills : Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. Mathematical Skills: Ability to add, subtract, multiply, 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. Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Supervisory Responsibilities: N/A Qualifications Expertise: Qualifications-Experience/Training/Education/Etc Required: Bachelor’s degree or higher in an applicable field (nursing, life sciences, or engineering) or equivalent in combination with 2+ years of Complaint Handling and/or MDR/Vigilance experience is required. Bachelor’s degree in Life Science or Engineering discipline preferred. Background in surgical Instruments, sterilization and Implants highly desirable. Knowledge and application of complaint handling regulations, medical device reporting and other quality standards. Knowledge of 21 CFR Part 820, Quality Systems Regulations. Knowledge of 21 CFR Part 803, Medical Device Reporting. Ability to drive results, foster teamwork, handle pressure, and provide feedback Able to make judgment calls using combination of knowledge of regulations, knowledge of device technology, clinical experience, and critical thinking. Ability to perform detail-oriented work with a high degree of accuracy. Proven ability to work cross-functionally in a team based environment. Proficient in MS Office Suite of products. Knowledge of SAP preferred. Knowledge of BDocs Preferred. Willingness to be flexible and adaptable to changing priorities. Excellent oral and written technical communication skills. Effective analytical and problem solving skills. Full understanding of Good Manufacturing Practice (GMP) preferred. Desired: N/A While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 30 pounds. B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com. Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
Professional Diversity Network Center Valley, Upper Saucon Township, PA, USA Full-Time