Manager, Quality Assurance Vigilance/MDR

Aesculap Inc. - Hazelwood, MO3.5

30+ days agoFull-time
Aesculap Inc.

Requisition ID 2018-12872
Company Aesculap Inc
# of Openings 1
Job Locations US-MO-Hazelwood
Category Quality
Position Type Regular Full-Time
Shift 8am - 5pm
Site Aesculap

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 the leadership of the Quality Assurance Complaints Department at the STL facility, to comply with Aesculap standard operating procedures (SOP) and 21 CFR Part 820, FDA Quality Systems Regulations and 21 CFR 1271.350. Works closely with other departments and Aesculap Germany to resolve quality related issues.

Responsibilities: Essential Duties
Evaluate incoming field reports, product returns and product analysis results for Aesculap products as necessary to determine MDR
Ensure complete, accurate and timely reporting of MDR/vigilance data as required by regulatory agencies.
Maintain the Complaint and MDR systems for Aesculap US.
Perform detailed investigation of adverse events by contacting internal resources, Aesculap field personnel and/or customers as appropriate. Generate medical device rationale or Medical Device Report for all products complaints.
Initiate and complete MedWatch reports for timely submission to the FDA. Conduct follow up investigations for reported events and assist in data collection for trending purposes.
Develop and maintain integrated system post market safety reports for devices.
Provide input on internal system and methods to maintain MDR/vigilance compliance and support post-market surveillance.
Respond in a timely manner to requests for additional information from US and OUS regulatory agencies.
Develop SOPs and guidance documents to assist other staff with device field event evaluation.
Uphold the company's core values of Integrity, Innovation, Accountability, and Teamwork
Demonstrate behavior consistent with the company's Code of Ethics and Conduct
Duties may be modified or assigned at any time to meet the needs of the business.
Provide leadership management and support to employees and coordinate their functional daily duties.
Perform all duties in a manner consistent with cGMP and Company's Standard Operating Procedures.
Responsible to review and approve quality investigations to ensure documentation is complete, accurate and timely
Manages the daily operations of the QA Customer Complaint area
Monitors, evaluates, and reports on any complaint product, also on internal investigation on repair issues.
Regular (monthly) communication with owners of open complaint investigations (including AAG, 3 rd party suppliers, and internal services). Document the progress and escalate late investigations to Quality Director.
Coordinate and/or conducts complaints training for the St. Louis facility and sales representatives and other Quality topics, as applicable
Collaborate with Quality Assurance daily activities including CAPA, Internal Audits, and Finding Response forms.
Collaborates with Director of Quality Operations to create monthly reports, quarterly reports,
Management Review presentations, and Adverse Trend Investigations.
Responsible for approving employees time and approving payroll
Responsible for completing employees performance evaluations
Responsible for coaching and disciplinary actions for department
Develops policies, procedures, and methods to evaluate and improve the quality of products, materials, components, and/or operations
Develops, assures and maintains the quality of processes, including standard procedures, quality audits/reviews
Must comply with applicable ISO and FDA regulations as stated in Quality Manual
Must embody the Company's Vision, Mission and Values
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.
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

Expertise: Qualifications - Experience/Training/Education/Etc

Required:
Requires a minimum of 6 years of relevant surgical, clinical or quality assurance in a medical device organization (or another regulated industry such as Pharma and Healthcare).
Requires 5+ years experience documenting customer complaints and US Vigilance Reports (MDRs).
Requires working knowledge in CAPA and internal auditing process.
Requires working knowledge a database applications (SAP perferred).
Requires working knowledge and moderate experience with document control systems (Bdocs preferred).
High level of computer proficiency is required.

Desired:
Functional understanding of Good Manufacturing Practice (GMP) QSR 820, FDA Quality System Regulations (QSR) & ISO13485 Quality Management Systems.
Excellent communication skills, over the telephone, in person, and in writing.
Knowledge of 21 CFR Part 820, Quality Systems Regulations.
Knowledge of 21 CFR Part 803, Medical Device Reporting.
Knowledge of 21 CFR Part 1271.350.

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.

Physical Demands:
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 employee must occasionally lift and/or move up to 30 pounds.

Work Environment:
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.
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