Instrumentation Laboratory - Bedford Senior Quality Systems Engineer 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.
Maintains support functions and programs for worldwide compliance issues to meet domestic and international regulatory requirements for product quality and commercialization. The main focus of this position is to maintain and monitor key Quality Systems. Duties may include CAPA, Internal Audits, Training Coordination, Supplier Audits, Procedure development, key metric reporting and other key project support under the supervision of the Quality System Manager.
Oversight, training, and maintenance of the CAPA program, acting as the primary liaison with different functional groups to ensure appropriate usage of the program.
Performs data entry and prepare reports/graphs related to special projects, CAPA, Internal Audits, Training, Supplier Audits, etc.
Maintains accurate documentation and files related to responsibilities and special projects.
Participates as auditor for the internal audit program at Bedford facility and supplier audits.
Coordinates the site training program to ensure that new personnel are trained to the cGMP and ISO requirements specific to their job responsibilities.
Annually reviews existing personnel base for additional training needs due to changes in the internal documents, and worldwide regulatory and quality regulations.
Assist with compliance, certification, audit documentation, reports and maintenance.
Support activities related to the harmonization of Bedford and Orangeburg Quality Systems.
Processes mapping and quality system development to support continuous improvement.
Additional responsibilities to support the Quality System as assigned
Budget managed (if applicable): N/A
Internal Networking/Key relationships
- To be determined based on department needs
Skills & Capabilities:
Strong attention to detail and accuracy, organizational, communication, analytical, and technical writing skills
Proficiency with standard software (Word, Excel, PowerPoint, Project, etc.), experience with SAP or database development is a plus
Excellent written and oral communication skills with ability to interact at all levels
Min Knowledge & Experience required for the position:
BS degree, preferably in an engineering/scientific/computer systems/ or quality management curriculum or equivalent experience; ASQ CQE and CBA/CQA preferred
Minimum 5 years of experience in a Quality System/Compliance role in the Medical Device or Pharma industry
Working knowledge of Quality Systems Regulations (FDA QSR 21 CFR Part 820) ISO 9001 and ISO 13485
Auditing experience (internal/supplier) required
International Mobility: Required: no
- Available to travel three days per month on average
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: 2020-3531
Shift: Not Applicable
Street: 180 Hartwell Road