Quality Engineer, Senior

Medical devices, Pharmaceuticals, Health, Social work
Not specified
Contract type:
Full time
Salary description:
Specialist areas:
Quality assurance (main), Audit/assessment, Consultancy, Health and safety, Operational improvement, Project management, Risk management
Start Date:
Aesculap Inc.
Job Ref:

Aesculap Inc.

Quality Engineer, Senior


Job ID: 28
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.


Position Summary:

Provide Quality Engineering leadership to operations for quality activities and maintain oversight of receiving, inspection, distribution, repackaging & labeling activities for quality compliance, while assuring that products and process are in accordance with company policies and procedures.

Together with the Operations, Technical Services and QC teams, the incumbent of this position will be accountable for the performance against key business objectives such as safety, quality, and compliance. The incumbent will drive peers to manage performance of equipment, systems, and processes; and will work to improve the output, efficiency or quality of the associated purchased and distributed products.

Responsibilities: Essential Duties
* Establishes quality standards for products and processes and suggest modifications meant to prevent defects in final products.
* Works closely with cross-functional teams, including product design, product management and operations, to identify and mitigate quality risks.
* Ability to lead quality initiatives as the project manager to timely completion
* Audits operational processes to ensure that established quality standards are met.
* 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.
* Supports Supplier Quality in monitoring supplier performance.
* Perform product and process validation activities including protocol development, execution, report writing as needed.
* 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.
* This position requires the handling of instruments that may have been contaminated by blood or other bodily fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees.
* Proficient in the use of Microsoft Excel, Power Point and Word.
* 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 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. Qualifications

Expertise: Qualifications - Experience/Training/Education/Etc

* BS in Engineering preferred, other technical degrees will be considered with relevant experience.
* CQE and CQA certifications preferred.
* 5+ years Quality Engineering experience with a Medical Device Company required.
* Must have understanding of FDA GMPs, ISO13485, and ISO14971.
* Knowledge of statistics and process controls.
* Project experience in UDI and labeling control preferred.
* Occasional business travel required, Ability to work non-standard schedule as needed 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 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 .

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.

Closing Date:
Contact Details:
Aesculap Inc.
Contact: N/A

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