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Instrumentation Laboratory - Bedford Quality Assurance Complaint Coordinator II in Bedford, Massachusetts

Instrumentation Laboratory

Our Passion. Your Results.

Founded in 1959, Instrumentation Laboratory (IL) is a global leader in the development, manufacturing and distribution of diagnostic solutions for Acute Care Diagnostics, patient blood management and Hemostasis testing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing medical professionals the most valuable and complete solutions to enhance patient care.

As an integral part of Werfen, a global healthcare company dedicated to delivering the highest quality in vitro diagnostic products, IL is supported by significant resources, outstanding scientific expertise and a tremendous knowledge base. IL is headquartered in Bedford, MA, USA.

Position Summary:

Assists in maintaining and improving the complaint handling system. Assists in the selection, adaptation and execution of analysis of complaint and product evaluation. Monitors the complaint handling system to assure compliance with FDA and ISO standards. Provides support to all internal and external customers to the system. Participates in the timely and effective resolution of customer complaints. Assists in the resolution of Regulatory Affairs issues generated by the complaint system. Assists in the generation of and maintenance of documentation for the complaint system. Provides any additional support to Quality Assurance Functions on as needed basis.

Key Accountabilities:

  • Trains personnel in the use of the complaint system.

  • Assists in the performance of root cause analysis of issues and suggests corrective action to the complaint handling system.

  • Assists in the establishment and development of documentation to maintain a compliant and effective complaint handling system.

  • Assists in the design of an effective support system for the use of the complaint handling system.

  • Provides closure to customer complaints.

  • Coordinates and attends meetings that impact the effectiveness of the complaint handling system

Budget managed (if applicable): N/A

Internal Networking/Key relationships:

  • To be determined based on department needs

Skills & Capabilities:

  • Excellent communication and training skills.

  • Proven problem solving skills

  • Strong computer skills with Excel required

Min Knowledge & Experience required for the position:

  • Bachelor's Degree in Medical Technology or a related discipline or equivalent

  • Minimum of 3 years in an associated discipline Knowledge of ISO Quality Systems and FDA requirements for the Medical Devices Industry

  • Understanding of the principles, theories and concepts related to the manufacture and support of Medical Devices.

International Mobility: Required: no

Travel requirements: No

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Instrumentation Laboratory appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V

Werfen is a global leader in in vitro diagnostics (IVD) in the specialities of Hemostasis, Acute Care Diagnostics and Autoimmunity. Our core business is dedicated to R&D, manufacturing and distribution of diagnostic systems for hospitals and clinical laboratories. Our other areas of expertise include Original Equipment Manufacturing, Clinical Software, Clinical Chemistry, Infusion Therapy, and Medical Devices and Scientific Instrumentation Distribution.

We operate directly in over 30 countries and in more than 100 territories through distributors. In 2016, our turnover was approximately 1.2 billion euros and we had an average workforce of 4,400 people. Currently, we are over 5,000 employees.

Job ID: 2020-3643

Shift: 1st

Street: 180 Hartwell Road