Quality Engineer, CAPA
Job ID: 2020-17111
Type: Regular Full-Time
# of Openings: 1
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.
Experienced Quality professional with FDA Quality Systems Regulations (21 CFR Part 820), ISO 13485 and ISO 14971 experience. Responsible for executing and managing multiple CAPAs simultaneously. Proven expertise in problem solving and utilization of root cause analysis tools. Works with quality management and senior management to ensure CAPAs are adequately resourced and executed in a timely manner. 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, Engineering, Supply Chain, and Customer Service to resolve quality related issues.
Responsibilities: Essential Duties
- Maintains and manages multiple CAPAs simultaneously, and aggressively facilitates each assigned CAPA to a timely closure (completion of Effectiveness Checks).
- Ensures CAPAs are documented and stored per record management procedures.
- Coaches and mentors other employees on CAPA execution and methodology.
- Proven leader to lead cross functional teams for CAPA projects.
- Aids in preparation of monthly CAPA Review Meetings.
- Identifies, documents, and initiates CAPAs with the CAPA board.
- Works with CAPA team members on utilization of root cause analysis tools
- 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 Quality management as requested.
- Active participation in External Audits, Management Reviews, and Internal Audits 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.
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
- BS in a Life Science or Engineering discipline is preferred with a minimum of 5 years Medical Device Industry or other regulated industry experience (i.e., Pharmaceutical, Aerospace, Automotive). ASQ certification(s) preferred (i.e., CQE, CQIA, CQM, CQA)
- 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.
- 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.
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.
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