Coordinator,Site PIR Operations
Allentown , Pennsylvania
January 05, 2017
Overview: With a nationwide sales team and several manufacturing locations, B. Braun Medical has become a leading full-line supplier of healthcare products and services in the U.S. The company is committed to delivering innovative products and services with unmatched quality, superior technology, and cost-effectiveness, while maintaining environmental responsibility. Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. B. Braun employs over 4,500 people in the USA. B. Braun Medical Inc. began its operations in the USA in 1957. Initially, the company manufactured and sold disposable plastic syringes. During the 1980s and early 1990s, the company undertook several expansions and enlarged its product line of disposable medical devices. With the acquisition of McGaw, Inc. in 1997, including Central Admixture Pharmacy Services, Inc. (CAPS®), B. Braun dramatically broadened its product lines and services to U.S. customers.

U.S. Facilities and Operations:

Supporting product sales are a network of nationwide marketing and manufacturing locations. Bethlehem, Pennsylvania, is home to the U.S. Corporate Headquarters along with the marketing offices of the Hospital, Outpatient Markets (OPM), Renal Therapies, Vascular Interventional, International, and OEM Divisions. Central Admixture Pharmacy Services, Inc.(CAPS®) is also managed from this location. The nearby Allentown, Pennsylvania, facility manufactures Needle-free products, IV Safety Catheters, Anesthesia Systems, Introducers, Pharmacy Admixture products. Vascular products including Right Heart Catheters and Interventional Accessories are also manufactured in Allentown. The Irvine, California facility produces IV Solutions, Basic and Specialty Nutrition, Drug Delivery, and BTC products. Infusion Pump Systems are manufactured in Carrollton, Texas and IV administration and IV and Irrigation sets are produced in the Dominican Republic.


Position Summary:

The Coordinator, Site PIR is responsible for assisting site quality leadership in the oversight and execution of complaint investigations. They help to organize, prioritize and review the work of the Site Quality Technicians run administrative and site level trending analysis. They work cross-functionally within their manufacturing or distribution site and with corporate staff to ensure that all aspects of the technical investigations into customer complaints are timely, thorough, and in accordance with company policies, procedures, and applicable regulations and standards.

Responsibilities: Essential Duties
  • Review incoming product investigations from the Product Quality Excellence team and assign investigation activities to Site Quality Technicians.
  • Provide reports to site quality management on the timeliness and effectiveness of product investigations and make recommendations for improvement where appropriate.
  • Analyze and review product investigation results and ensure that all technical information is documented in a thorough and timely manner.
  • Responsibly unpack, identify, organize, and track customer complaint samples including those which may have come in contact with cytoxic or caustic medications, human blood, tissue, and other body fluids in a manner that ensures sample integrity and traceability is preserved and that the safety of all B. Braun personnel is maintained.
  • Perform technical product investigations which include testing of returned samples, verifying the accuracy of the reported problem, review of manufacturing records, and requests root cause analysis and corrective and preventive actions from the appropriate internal and external contacts.
  • Thoroughly and accurately document all investigation findings, corrections, and corrective and preventive actions in B. Braun Complaint files and communicate investigation results to Product Quality Excellence.
  • Conduct data analysis and reporting for site quality data sources including confirmed defect trend reports, investigation aging reports, and other reports as requested by management.
  • Purchase supplies and materials necessary to perform job duties.
  • Identify opportunities for continuous improvement in all aspects of job function and actively participate or lead initiatives to implement change.
  • Interact with external customers, internal peers, and regulatory agencies in a friendly, professional manner to present and/or receive information related to customer complaints.
  • Coordinate, receive, and review product investigation and/or inspection with external laboratories or suppliers.
  • Perform incoming, in-process, and final product testing and release activities in accordance with company policies and procedures where required by management.
Expertise: Knowledge & Skills
  • Excellent verbal, written, and interpersonal communication skills
  • Able to read, interpret, and conduct testing/analysis in accordance with requirements of blueprints, specifications, or other technical documentation
  • Proficient in the use of computers
  • Ability to interact with external customers in a polite and professional manner
  • Ability organize and prioritize own work and the work of a team to meet deadlines
  • Ability to exercise initiative and work independently

Qualifications: Expertise: Qualifications - Experience/Training/Education/Etc

  • Associates degree in a related technical discipline (i.e. engineering technician, chemistry, biology)
  • 2-3 years experience in biotech, laboratory, or quality control/quality assurance function
  • 2-3 years Customer Complaint Experience
  • ASQ Certified Quality Technician
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.

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:

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.

A little about us:
One of the world's leading healthcare suppliers.

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