Responsible for working as the Quality Assurance member on new product development projects for the B. Braun Medical Inc medical device franchise. The desired candidate will have experience with design controls and the associated regulations related to medical devices. The position will also be responsible for working with external specification developers and contract manufacturers as part of new product development and product life cycle management that includes design changes. The ability to ... more details
Sr. Quality Engineer, Design Assurance
Job LocationsUS-PA-Allentown
Requisition ID
2024-24062
Company
B. Braun Medical Inc
# of Openings
1
Category
Quality
Position Type
Hybrid Full Time
Shift
Mon-Frii 8:00am-5:00pm
Site
Corporate
Overview
About B. Braun
B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.
Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.BBraunUSA.com.
Responsibilities
Position Summary:
Responsible for working as the Quality Assurance member on new product development projects for the B. Braun Medical Inc medical device franchise. The desired candidate will have experience with design controls and the associated regulations related to medical devices. The position will also be responsible for working with external specification developers and contract manufacturers as part of new product development and product life cycle management that includes design changes. The ability to work in a cross functional team and ensure compliant project execution is a must.
Responsibilities: Essential Duties
Provides Design Assurance Quality Engineering support, to the R&D and Sustaining Engineering organization for new products, product design modifications, and OEM customers; this includes creation of Quality and Validation plans, risk analysis, traceability matrixes, URS/FS, Design Reviews, customer interface, and follow
Ensure appropriateness application of company policies and procedures for medical device design controls, risk management, test method development, statistical data analysis, and support of regulatory filings.
Maintain oversight of cGMP documentation, including, but not limited to design history files, regulatory submissions, device history records, change control, validations, methods, and technology
Ensure documents are thorough, accurate and compliant to support regulatory inspections and
Operates in accordance with company policies, procedures and regulatory requirements (FDA, ISO, MDD, CMDR, ).
Defines implements and monitors metrics for key Prepare and present trend reports to management, as applicable.
Proactively investigates, identifies and implements improved quality practices and drives continuous improvement efforts through facilitating, leading, and collaborating with cross function
Prepares reports for key quality metrics and lead continuous improvement efforts in Quality
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
General: It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons.
Expertise: Knowledge & Skills
Please refer to the Corporate Guidelines or BBMUS Guidelines or job specific authorities where applicable. This list is however not exhaustive and may be amended by the Management from time to time.
Requires advanced knowledge of professional field and industry. Influences the development of and drives the application of principles, theories, concepts. Determines best course of action.
Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, and/or reviewing the work of peers.
Judgement is required in resolving all day-to-day problems.
Contacts are primarily with department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors.
Bachelor's degree required or equivalent combination of education and experience.
06-08 years related experience required.
Occasional business travel required
Regular and predictable attendance
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.
Additional Information
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.
Physical Demands:
While performing the duties of this job, the employee is expected to:
Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.
Lifting, Carrying, Pushing, Pulling and Reaching:
Occasionally: Reaching upward and downward, Push/pull, Stand
Frequently: Sit, Visual Acuity with or without corrective lenses
Frequently: Finger feeling, Hearing - ordinary, fine distinction, loud (hearing protection required), Seeing - depth perception, color vision, field of vision/peripheral, Sitting , Talking - ordinary, loud/quick
Constantly: N/A
Environmental Conditions:
Occasionally: Proximity to moving parts
Frequently: N/A
Constantly: N/A
Work Environment:
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.
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.
Notices
Equal Opportunity Employer Veterans/Disabled
Need help finding the right job?
We can recommend jobs specifically for you!Click here to get started.
Job Abstracts is an independent Job Search Engine. Job Abstracts is not an agent or representative and is not endorsed, sponsored or affiliated with any employer. Job Abstracts uses proprietary technology to keep the availability and accuracy of its job listings and their details. All trademarks, service marks, logos, domain names, and job descriptions are the property of their respective holder. Job Abstracts does not have its members apply for a job on the jobabstracts.com website. Additionally, Job Abstracts may provide a list of third-party job listings that may not be affiliated with any employer. Please make sure you understand and agree to the website's Terms & Conditions and Privacy Policies you are applying on as they may differ from ours and are not in our control.
We would like to take a second to Welcome You to Job Abstracts, the nation’s largest Pure Job Board. With over 3.1 million job listings from 15,000+ Companies & Organizations, we help job searchers find careers that match their interests. As an anonymous user, you have probably discovered how easy our system is to use. However, you have just scratched the surface of what we can offer.
We encourage you to Register so you can use our most powerful features: searching with multiple terms, setting up multiple locations, establishing favorite companies, and accessing your search history. If you find a job you like, you can apply directly for it, and then, keep notes on it. We will also keep a lookout for jobs that match your search terms and email you when we find something you may like.
You can register for free and the system is free to use. If you like our system so far, click on Register and unlock the power required by serious job searchers.
Any time you conduct a search, the system shows you job matches, ranked by their Relevance Score (RS).
The score is calculated by a proprietary algorithm that uses Intelligent Machine Learning.
The Relevance Score tells you how well the job opportunity matches your search term or terms.
When not logged in, the system is limited to one search term. Scores for single term matches are usually lower.
When you register, log in, and set up multiple terms prioritized by importance, the jobs found for you will receive a much higher Relevance Score.