Senior Quality Assurance Specialist, Complaints
Company: Aesculap Inc.
Posted on: February 8, 2019
Requisition ID 25Company Aesculap Inc# of Openings 1Job Locations USCategory QualityPosition Type Regular Full-TimeShift 8am -5 pmSite AesculapOverview 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 Senior QA Specialist, Complaints, is responsible for verification of Complaint and MDR content, including determination of medical review escalation, within the Complaint Handling Unit
Responsibilities: Essential Duties
- Evaluates information received by AIC and AIS customers, Sales, Marketing, Customer Service, Aesculap Technical Services or any other source of product or service complaint.
- Enters information and data into complaint handling system as appropriate.
- Verifies that communication and investigation data is recorded in complaint files appropriately within the system.
- Evaluates complaints for adverse event reporting as applicable. Verifies decisions for "Vigilance report not required" determinations.
- Verifies comprehensive content of draft MDR reports prior to submission of Form 3500A to FDA.
- Within complaint system, acts as Safety Officer for adverse event reporting purposes.
- Based on assessed risks, coordinates the escalation to Medical Reviewer(s) for decisions regarding the potential for serious injuries.
- As applicable, communicates with sales representatives and customers to coordinate return of complaint product and obtain additional information as necessary.
- As applicable, evaluate returned complaint product and conduct follow up as required.
- Triggers local complaint investigations as appropriate (e.g., complaints on service repairs or loaner set distribution) and supports those investigations as requested.
- Monitors and reports on progress of complaint investigations from OEM, contract manufacturers or other third party suppliers.
- Monitors, evaluates, and reports on complaint product, and internal investigation.
- Runs complaint reports as requested.
- Trains personnel on complaint handling and adverse event reporting as required.
- Supports other Quality related activities as assigned.
- Acts as informal resource for colleagues with less experience
- Must comply with applicable ISO and FDA regulations as stated in Quality Manual
- Must embody the Company's Vision, Mission and Values
- Other duties may be assigned. Expertise: Knowledge & Skills
- 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. Qualifications Required:
- Valid Nursing license/credential (RN or LPN/LVN preferred). Associates degree or higher in an applicable field (nursing, life sciences, or engineering preferred).
- Requires 3+ years experience documenting customer complaints. Prefer 2+ years experience reviewing US Vigilance Reports (MDRs) within the medical device industry.
- Requires high level of attention to detail (for database entry and content review).
- Requires working knowledge of database applications (SAP preferred)
- Requires working knowledge of document control systems (Bdocs preferred)
- Requires knowledge of 21 CFR 820 (Quality System Regulations), 21 CFR 803 (Medical Device Reporting), and 21 CFR 1271.350 (HCT/P Reporting), and Good Manufacturing Practices (GMP)
- Requires high level of computer proficiency.
- Requires good communication skills (over the telephone, in person, and in writing) Desired:
- Preferred: Internal Auditor certification (ASQ-CQA, or ISO 13485 lead auditor certification.
- Preferred: experience participating, and leading, CAPA investigations Other Responsibilities: Other Duties
The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position could require the handling of instruments that may or may not have been contaminated by blood or other body fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees.The noise level in the work environment is usually moderate.
Keywords: Aesculap Inc., Bethlehem , Senior Quality Assurance Specialist, Complaints, Other , Bethlehem, Pennsylvania
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