B. Braun

Specialist, Product Quality Excellence

Job Locations US-PA-Allentown
Requisition ID
2020-16711
Company
B. Braun Medical Inc
# of Openings
1
Category
Quality
Position Type
Regular Full-Time
Shift
M - F / 8:00-4:30
Site
Allentown, PA

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 www.BBraunUSA.com.

Responsibilities

Position Summary:

The Specialist, Product Quality Excellence is responsible for assisting the Director, Product Quality Excellence in oversight and administration of the B. Braun Post-Market Surveillance System. They monitor and analyze all aspects of post-market data to identify potential health and safety risks, opportunities for product quality improvement, and ensure that all applicable regulatory and industry standards for complaint management and regulatory reporting are met. They work collaboratively across all departments and manufacturing sites to ensure that B. Braun maintains a position as a premiere provider of quality healthcare products to the markets we serve.

Responsibilities: Essential Duties

  • Review and approve all customer complaint files for compliance with U.S. FDA, Health Canada Regulations, ISO standards and other applicable regulations and standards.
  • Functions as the SAP Safety Officer Role for U.S. Hospital Care, OPM, and Avitum medical device products.
  • Makes timely and effective decisions regarding U.S. Medical Device Reports (MDRs) , Canadian Medical Product Reports (MPRs), and NDA Field Alert Reports (FARs) and ensures all cases are filed in accordance with applicable regulations.
  • Supports the Scientific & Medical Affairs and Regulatory Affairs Departments with Adverse Event Reporting (AER) and Adverse Drug Experience (ADE) decision making and ensures all cases are filed in accordance with applicable regulations.
  • Works collaboratively with global Safety Officers to communicate potential cases which require EU or other country specific vigilance reporting requirements
  • Perform analysis and trending of post-market data sources to support decision making for CAPA, Health Risk Assessments, Vigilance Reporting, and Recall.
  • Monitors the Post-Market Surveillance System for effectiveness, keeps abreast of industry best practices and guidance documentation to identify and implement opportunities for continuous improvement

Expertise: Knowledge & Skills

  • Solid knowledge of product usage, medical terminology, and environmental regulations.
  • Proficiency with cGMP, CMDR, & MDD requirements for complaint management and regulatory reporting.
  • Excellent verbal, written, and interpersonal communication skills
  • Proficient in the use of computers
  • Ability to interact with external customers in a polite and professional manner
  • Ability to lead a team, organize and prioritize work, and meet deadlines
  • Ability to exercise initiative and work independently
  • Thorough knowledge of company products, processes, and procedures

Qualifications

Expertise: Qualifications - Experience/Training/Education/Etc

Required:

  • Bachelors Degree in Biomedical Engineering, Nursing, Risk Management, or similar
  • Minimum of four (4) years of experience in Quality Assurance or Risk Management with a focus on complaint management and/or vigilance reporting

Desired:

  • Bilingual in German or French.
  • Proficiency in interacting with FDA, Health Canada or other Regulatory Bodies

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:

  • Performs other related duties as required by management

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:

 

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.

 

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. The noise level in the work environment is usually moderate.

Notices

Equal Opportunity Employer Veterans/Disabled

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