B. Braun Medical Inc. Hazelwood , MO 63042
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.
Experienced Quality professional with, FDA Quality Systems Regulations (21 CFR Part 820), ISO 13485 and ISO 14971 experience. Responsible for ensuring the adequacy of the organizations CAPA system to regulations. Root cause analysis and problem solving expert and trainer. Works with quality management and senior management to ensure CAPAs are adequately resourced and executed in a timely manner. Knowledge and experience with SAP or similar software systems to aid in problem solving and solution implementation. Writes and implements standard operating procedures (SOP) which are necessary to ensure Quality compliance and the safety and performance of Aesculap distributed products. Works closely with other departments including but not limited to Operations, Complaint Handling, Marketing, Supply Chain, and Customer Service to resolve quality related issues.
Directly supervise the work activities of employees engaged in providing support.
Maintains and manages the CAPA log.
Ensures all CAPAs are documented and stored per record management procedures.
Trains employees on CAPA execution and methodology.
Manages CAPA activities for all locations.
Prepares and maintains monthly CAPA Review Meetings.
Identifies, documents, and initiates CAPAs with the CAPA board.
Assist with internal audits.
Trains employees on proper root cause analysis.
Writes and/or assists in writing new SOPs or revising existing SOPs as required. Assists in the implementation/training of those new or revised documents.
Issues monthly reports to the QC management as requested.
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 by manager.
Quality Engineer, CAPA
Quality Specialist(s) 2-3
Perform annual performance evaluations
Monitor/Approve Time system requirements for subordinates
Submit disciplinary write up based on compliance with company policies
Expertise: Knowledge & 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.
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
BS in a Life Science or Engineering discipline is preferred with a minimum of 5-8 years Medical Device Industry or other regulated industry experience and 2+ years of supervisor experience or project management.
ASQ certification preferred.
Requires knowledge of FDA Quality System Regulation, ISO 13485 and ISO 14971.
Requires understanding of problem solving and root cause analysis tools.
Must have experience in the use of CAPA methodology.
Must be knowledgeable and demonstrate proficiency with SAP
Microsoft Office (Word, Excel, Power Point).
Must have ability to process, analyze and present data.
Good oral and written skills required.
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 20 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 Equal Opportunity Employer Minorities /Women/ Veterans/Disabled
Through its "Sharing Expertise" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
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.