Job ID: 2021-18406 Type: Regular Full-Time # of Openings: 1 Category: Healthcare St. Louis, MO
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.
Provide Quality Engineering leadership to the company for quality activities and maintain oversight of, Software Validations, CAPA ownership and for quality compliance, while assuring that products and process are in accordance with company policies and procedures. Together with various members of the organization, this position is accountable for the performance against key business objectives such as safety, quality, and compliance. Drive peers to manage performance of CAPAs, Software Systems, and processes; and will work to improve the output, efficiency or quality.
Principal Duties Responsibilities:
Establishes quality standards for implementation and validation of software systems within Aesculap.
Knowledge of 21 CFR Part 11 software validations including creation of risk documentation, system requirements, user requirements, validation plans, and test scripts.
Quality liaison with IT to ensure all software systems are assessed for GXP impact, and validated against the regulations as appropriate.
Works closely with cross-functional teams, including IT, product design, product management and operations, to identify and mitigate quality risks.
Implement process improvements for the quality activities including utilization of the QM module in SAP.
Ability to lead quality initiatives as the project manager to timely completion
Conducts root cause analysis for defects, non-conformities or other quality failures.
Review and approve product / process deviations or rework documentation.
Develop Quality & Deviation Plans as needed.
Perform internal audits.
Knowledge of Statistics and process controls.
Acquire and analyze data using appropriate quantitative methods to facilitate process analysis and improvements.
Use problem solving techniques to conduct CAPA, complaint investigation, root cause analysis, and quality improvement when necessary.
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:
Must be able to travel by air and car, and work occasional weekends.
Requires excellent written and interpersonal communication skills.
Uses professional concepts in accordance with company objectives to help solve complex problems in creative and effective ways, complete projects as assigned and achieve goals.
Coordinates and supports team activities using creative thinking and organizational skills.
Works well in a team environment with limited supervision.
Supervisory Responsibilities: N/A
Expertise: Knowledge & Skills
Language and mathematical skills; reasoning ability:
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.
3-5 yrs. software validations experience with a pharma or medical device company.
Must have understanding of FDA GMPs, ISO13485, and ISO14971.
Knowledge of statistics and process controls.
Occasional business travel required, Ability to work non-standard schedule as needed
SAP experience is preferred.
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 50 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 www.bbraunusa.com.
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.