- Provides Design Assurance Quality Engineering support, to the R&D organization for new products, 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 through.
- Responsible for data trending and analysis, issue identification and resolution.
- Prepares reports for key quality metrics and lead continuous improvement efforts in Quality.
- Operates in accordance with company policies, procedures and regulatory requirements (FDA, ISO, MDD, CMDR, etc.).
- Defines implements and monitors metrics for key indicators. Prepare and present trend reports to management, as applicable.
- Drives continuous improvement efforts through facilitating, leading, and collaborating with cross function teams.
- The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
- Provide Design Controls support related to new product development, product design modifications and transfer to manufacturing.
- Ensure appropriate application of company policies and procedures related to medical device development - Design Controls, Risk Management, Test Method Development, and Statistical Data Analysis.
- Maintain oversight of cGMP documentation, including, but not limited to Design History Files, Device Master Record, Device History Records, Change Control and Technology Transfer.
- Operate in accordance with company policies, procedures and regulatory requirements (FDA, ISO, MDD, MDR, CMDR).
- 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.
- 03+ years related experience required.
- Regular and predictable attendance
- Occasional business travel required
- 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.
- Occasionally:Reaching upward and downward, Push/pull, Stand
- Frequently:Sit, Visual Acuity with or without corrective lenses
- Constantly:N/A
- Occasionally:Climbing stairs/ladders, Push/pull, Reaching upward and downward, Standing, Walking
- 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
- Occasionally:Proximity to moving parts
- Frequently:N/A
- Constantly:N/A
- Noise Intensity:Moderate
- Occasionally:Production/manufacturing environment, Lab environment
- Frequently:N/A
- Constantly:Office environment
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Quality Engineer II, Design Assurance - Allentown, United States - B. Braun Medical Inc
Description
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 61,000 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
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
Additional Responsibilities: Essential Duties:
Expertise: Knowledge & Skills
#ID
#LI
#AL
Target Based Range:$79,800 - $89,800
Qualifications:
Expertise: Qualifications -Education/Experience/Training/Etc
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.
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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:
Lifting, Carrying, Pushing, Pulling and Reaching:
Activities:
Environmental Conditions:
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
Through its Sharing Expertise initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
Notices:
Equal Opportunity Employer Veterans/Disabled
Quality Engineer II, Design Assurance professionals in Allentown
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Elwaleed Khafagy
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