B. Braun

Sr. Quality Engineer - Design Assurance

Job Locations US-PA-Allentown
Requisition ID
2021-19671
Company
B. Braun Medical Inc
# of Openings
1
Category
Quality
Position Type
Regular Full-Time
Shift
8:00 AM - 5:00 PM
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:

 

 

Responsibilities: Essential Duties

  • Establishes quality standards for products and processes and suggest modifications meant to prevent defects in components or final products.
  • Works closely with cross functional teams, including product design, product management and production, to identify and mitigate quality risks.
  • Audits production processes, raw materials or suppliers/vendors to ensure that established quality standards are met.
  • Conducts root cause analysis for defects, non conformities or other quality failures.
  • May be responsible for ensuring compliance with formal external quality standards, such as ISO 9001.

 

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

 

Expertise: Knowledge & Skills

  • 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.
  • Provides direct or supervision to a group of employees, assigning tasks and checking work at frequent intervals. Accountabilities include work and people scheduling, performance management and recommendations for hiring decisions.
  • Judgement is required in resolving complex problems based on experience.
  • Contacts are primarily with department supervisors, leads, subordinates, and peers. Frequent contact with external contractors/vendors.

Additional Responsibilities: Essential Duties:

  • Provide Design Assurance support related to new product development, product design modifications and transfer to manufacturing.
  • Provide leadership, expertise and guidance on all Design Assurance and Risk Management activities related to the development of new products and product improvements.
  • Ensure appropriate application of company policies and procedures related to medical device development - 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 and Technology Transfer.
  • Support the continuous improvement of the quality system elements that support the design, development, and manufacturing transfer of new products.
  • Provide support for investigations and recommend, develop and implement effective corrective actions.
  • Provide support during regulatory inspections and customer audits.
  • Identify and implement quality system improvements when gaps are identified through audits and departmental reviews.
  • Proactively investigate, identify and implement improved quality practices and drive continuous improvement efforts through facilitating, leading, and collaborating with cross functional teams.
  • Operate in accordance with company policies, procedures and regulatory requirements (FDA, ISO, MDD, CMDR).

 

Knowledge and Skills:

  • Experience and knowledge of ISO 14791 and ISO 13485

Qualifications

Expertise: Qualifications -Education/Experience/Training/Etc

 

Required:

  • Bachelor's degree required, Master's degree preferred.
  • 08-10 years related experience required.
  • Applicable industry/professional certification required.
  • Regular and predictable attendance
  • Occasional business travel required, Secrecy and invention agreement and non-compete agreement, Ability to work non-standard schedule as needed

 

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.

 

Other

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, Visual Acuity with or without corrective lenses
  • Frequently:Sit
  • Constantly:N/A

Activities:

  • Occasionally:Push/pull, Reaching upward and downward, Seeing - depth perception, color vision, field of vision/peripheral, Standing, Walking
  • Frequently:Finger feeling, Hearing - ordinary, fine distinction, loud (hearing protection required), 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.

  • Noise Intensity:Low
  • Occasionally:Office environment, Production/manufacturing environment, Warehouse environment, Lab environment
  • Frequently:N/A
  • Constantly:Office environment

 

Notices

Equal Opportunity Employer Veterans/Disabled

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