Aesculap Inc.
Sr. Quality Engineer Field Actions
US-PA-Center Valley
Job ID: 28
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:
Responsible for implementing, maintaining and improving the Quality Vigilance System for all Aesculap US sites. Specifically, interactions with the Food and Drug administration with regards to corrections and removals. Instrumental in contributing to defining the direction and plans for recalls and ensuring the site is 21 CFR 806 complaint. Will lead recalls, Corrections and Removals. Also he/she will work directly with the Vigilance group to monitor possible recall needs.
Must be comfortable exercising latitude in ensuring the site is compliant with the Aesculap Quality System, the FDA quality regulations and standards it is built on. Comfortable coaching all employees on the Aesculap Correction and Removal process and working professionally with others to reach understanding and agreements as necessary. Represents the company as a primary FDA Recall contact, comfortable communicating internally and externally as well as collaborating at various levels. This individual must be comfortable working autonomously in that much of their work will be completed with limited oversight.
Responsibilities: Essential Duties
- 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.
- Contribute to creating a climate of trust, ethics, and accountability by effectively seeking out and accepting feedback from others.
- Coordinates, and monitors FDA vigilance notifications and recall activities.
- Acts as the Quality representative for communication and interfacing with the FDA regarding Field Safety Notice 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 and recalls are managed effectively and efficiently.
- Support decision making for Health Hazzard 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.
- Coordinates and monitors FDA vigilance notifications, recalls and Health Risk Assessment (HRA) and Health Hazard Evaluation (HHE) activities.
- Acts as the Quality representative for communication with the FDA regarding Field Safety Notice, Recall Notifications and inventory recovery reconciliation.
- 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 assignedPossess the ability to exceed expectations with the customer in mind and take responsibility for driving key results as well as empower others to achieve desired outcomes.
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.
- Contribute to creating a climate of trust, ethics, and accountability by effectively seeking out and accepting feedback from others.
- Possess the ability to exceed expectations with the customer in mind and take responsibility for driving key results as well as empower others to achieve desired outcomes.
- Demonstrate behaviors that drive efficiency by understanding and improving processes as well as sharing best practices.
Supervisory Responsibilities:Not Applicable
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 apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
- Reasoning Ability: Ability to define problems, collect date, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Qualifications
Expertise: Qualifications-Experience/Training/Education/Etc
Required:
- Bachelor of Science required. Life Sciences and/or Engineering degree preferred.
- 6-10 years’ experience in Medical Device Quality Compliance with BS/BA or 4 years with MS/MA 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, PowerPoint, Lotus Notes, Excel Charts/Graphs, SAP, BDocs).
- Demonstrated excellent written and oral communications with the ability to influence and interface across the organization
- Advanced presentation skills
- Experience with FDA and ISO 13485 and other applicable standards.
- Must have excellent interpersonal, facilitation, negotiation, consensus building, conflict resolution and organizational skills.
- Experience interfacing with FDA/ISO personnel. Inspection front room experienced preferred.
- Demonstrated excellent written and oral communications with the ability to influence and interface across the organization.
- Advanced presentation skills using PowerPoint.
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 ..
Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. 
Sr. Quality Engineer Field Actions – Center Valley, Pennsylvania
