Instrumentation Laboratory - Bedford Senior International Quality System Specialist II in Bedford, Massachusetts
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.
Responsible for the implementation of programs that will assess, integrate, and develop Quality Management System elements for the Werfen Affiliates importing, distributing, servicing, warehousing, and managing Instrumentation Laboratory products to meet any applicable internal and external regulatory and QS compliance requirements.
Manage projects to implement, integrate and improve the Affiliates quality management system for regulatory compliance and organizational objectives
Identify and improve any system gaps at Instrumentation Laboratory to monitor Affiliate's performance in quality system control/ management effectively
Identify and harmonize critical processes at each Affiliates in line with the organization objectives - identify system gaps at each of the Affiliates and work with them to implement the process to meet quality and regulatory requirements
Implement and maintain Affiliate harmonized procedures
Implement and maintain Affiliate harmonized training program for critical processes
Provide support to Affiliates for QMS-related request
- Participates various industry activities/associations about regulatory intelligence in different regions
Budget Managed (if applicable)
Internal Networking/Key Relationships
To be determined based on department needs, to include interactions such as:
All IL departments
Affiliate QARA, Management, Marketing, and other department(s) required/ involved
Other Werfen Manufacturer QARA
Skills & Capabilities:
The ideal candidate for this position will exhibit the following skills and capabilities:
Attention to Detail: Ability to pay close attention to detail is required
Accuracy: Work is accurate and complete
Performance Standards: Demonstrated ability to meet department goals
Communication: Excellent written, verbal and presentation skills
Discretion: Acts with integrity in all situations and can maintain appropriate confidentiality
Multi-Tasking: Ability to manage multiple priorities, and support changing business needs
Collaboration: Ability to work within a multi-function team to bring best solutions to the team or customer
Independence: self-motivated-works under minimal supervision
Professionalism: Must demonstrate professionalism during all interactions within company, customer and third parties
Takes Initiative: Serves as a role model for “Quality First” by continuously improving on what matters most to customers
Problem Solving: Promptly and effectively handles issues and problems
Decision making: Makes decisions based on data and risk determination
Minimum Knowledge & Experience required for the position:
Minimum of bachelor’s degree, in related scientific or technical field
Minimum 10 years (or 7 years with advanced degree) of experience in the medical device, IVD or other regulated industry
Strong understanding of US FDA Quality System Regulations (QSR) is required
Strong understanding of ISO 13485:2016 is required
Strong understanding of Good Manufacturing Practices & Good Documentation Practices
Strong understanding of Quality Agreements
Strong Internal Auditing skills and understanding of Non-Conformance Reports / Deviations
Strong Technical Writing skills
Computer literacy required; Strong working knowledge of Microsoft Office programs especially Power-point required.
Strong planning, organizational and time management skills are required
Ability to prioritize urgent matters
Proven capabilities of implementing/maintaining ISO 13485 Quality Systems and/or any other Medical Device/IVD Quality Management System required in different jurisdictions (MDSAP, IVDR, etc.)
Working knowledge on international regulatory systems and regulations / experience in international regulatory intelligence
Strong understanding of the business goals, customer needs and competitive environment in Affiliates
- Required: No
- Up to 20% of time
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 specialties 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: 2021-4116
Street: 180 Hartwell Road