Design Quality Engineer
Posted on Mar 11, 2019 by Aesculap Implant Systems
Aesculap Implant Systems
Requisition ID 24
Company Aesculap Implant Systems
# of Openings 1
Job Locations US-PA-Breinigsville
Position Type Regular Full-Time
Shift 8 a.m. to 5 p.m.
Site Aesculap Implant Systems
Aesculap Implant Systems, LLC, a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients' lives.
The Design Quality Engineer (DQE) will be involved with developing and implementing processes to ensure that Aesculap products are designed and produced to meet or exceed customer and regulatory requirements. The DQE will participate on cross-functional design and manufacturing teams and provide independent oversight and review of project deliverables throughout the product lifecycle.
Responsibilities: Essential Duties:
- • Assist in the development and implementation of the Design, Production & Process Controls by using Quality principles, systems, methods, tools, and standards.
- Use experience with Design Controls and Risk Management principles to support the product development and lifecycle management of class I and II devices. Review and approve Design Control and Risk Management documentation (Design Inputs, Design Outputs, FMEAs, Hazard Analysis, etc.).
- Review and approve drawings, calculations, specifications and other design documentation as required.
- Review and approve product / process deviations or rework documentation.
- Develop Quality Plans.
- Perform both internal and external (supplier) audits.
- Support Quality management to qualify suppliers.
- Plan, control, and assure product and process quality in accordance with Quality principles which includes, but is not limited to, specification development, material control, acceptance sampling plans, statistical methods, measurement systems and process validation.
- Support product, process and sterilization validation activities including protocol development, execution, report writing and external vendor management.
- 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
Expertise: Knowledge & Skills
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.
- BS in Engineering preferred, BS in Life Sciences or Physical Science will be considered with relevant experience.
- CQE and CQA certification preferred.
- 3 - 5 years Quality Engineering experience with a Medical Device Company required.
- Must have understanding of FDA GMPs, ISO13485, and ISO14971.
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.
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 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.
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.
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.
- 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.
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. The noise level in the work environment is usually moderate.
Aesculap Implant Systems
Aesculap Implant Systems