Business Professional Job In Pennsylvania
Sr. Quality Specialist - RecallsNext Steps... Apply Now
Company Aesculap Inc
# of Openings 1
Job Locations US-PA-Center Valley
Position Type Regular Full-Time
Shift 8 a.m. to 5 p.m.
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.
This Sr. QA Specialist's primary responsibilities are to conduct and manage recall activities (Corrections and Removals), related to Aesculap quality and regulatory practices. He/She will facilitate the implementation of timely and effective corrective actions to appropriately mitigate risk. This individual will work cross-functionally with all departments to lead the review of policies, regulations, interpretation of requirements, and consult areas of technical expertise to proactively prevent risk. He/She will work with key external and internal contacts at various organizational levels as the expert in the quality compliance function. Must have excellent interpersonal, facilitation, negotiation, consensus building, conflict resolution and organizational skills. Work is performed without appreciable direction and exercises considerable latitude in determining deliverables of assignments.
Responsibilities: Essential Duties
- Coordinates, and monitors FDA vigilance notifications and recall activities.
- Acts as the Quality representative for communication and interfacing with the FDA/CDER/CBER regarding Field Safety Notice, HTC/P deviation reports and Recall Notifications.
- Coordinates and organizes Site Corrections and Removals (recalls). Expedites the coordination of activities for timely FDA reporting and interfaces with Supply Chain, Marketing, and Product Managers.
- Leads Health Hazard Assessment (HHA) and Health Hazard Evaluation (HHE) activities with collaboration from Regulatory Affairs, Product Managers, R&D Engineers, and the applicable OEM as part of Aesculap's Risk Management Program.
- Ensures corrections, removals, deviations and recalls are managed effectively and efficiently.
- Support decision making for Health Hazard Assessments, Vigilance Reporting, CAPA, and Recall based on analysis and trending of post-market data sources.
- Assists with onsite ISO and FDA inspections and maintenance of formal responses to findings.
- Coordinates, monitors, and analyzes trending of Recall data for Monthly Quality Data Review and Management Review Meeting (MRM) discussion.
- Acts as the lead and mentor for guidance of Aesculap on Corrections and Removal (Recalls).
- Ability to process complaints and MDRs as needed.
- 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
Secondary or peripheral job functions:
- Assists in the assembly of technical files for the FDA, and other Regulatory Bodies, as applicable.
- Assists and coaches Aesculap employees on Correction and Removal regulations.
- Maintains Quality Recall Dashboard metrics for input into Management Reviews.
Expertise: Knowledge & Skills
- Language Skills: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, and/or boards of directors.
- 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.
Expertise: Qualifications - Experience/Training/Education/Etc
- Bachelor of Science required. Life Sciences and/or Engineering degree preferred.
- 6+ years of experience in Medical Device or Pharma QSR/ISO required
- Recall experience to include submission of 806 reports required.
- Knowledge of complaint/MDR processing using FDA Webtrader software preferred.
- Superb conflict management skills.
- Knowledge of Electronic Submission of 806 Reports for Corrections and Removals
- Experience interfacing with Regulatory bodies- FDA/ISO
- Must have excellent working knowledge of FDA Regulations
- Requires computer skills (Word, Lotus Notes, Excel, SAP, Charts and Graphs).
- Demonstrated excellent written and oral communications with the ability to influence and interface across the organization
- Advanced presentation skills
- Excel at project planning and project management
- Experience with FDA and ISO 13485 and other applicable standards.
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.
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.
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.
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 finger, 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.
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.