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Instrumentation Laboratory - Bedford Senior Software Quality Engineer in Bedford, Massachusetts

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.

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

Position Summary

Under minimum supervision, as part of the Software Quality and Compliance group, this engineer would ensure the quality of IL products through the application of standard software practices and adherence to the IL quality management system.

Working with other members of the Software Quality Team and Quality Engineering, will assure the compliance to safety and regulatory requirements prior to manufacturing and market release. Must be familiar with FDA QSR regulations and must be a hands-on contributor. Tasks include various development and test activities, perform gap analysis against project documentation, report non-compliance issues and help in working towards their resolution. Will work with a corresponding Quality Engineer throughout project assignments.

Key Accountabilities:

  • Represent Software Quality and Compliance in product development teams/projects.

  • Work with Quality Engineering and Software Engineering to ensure compliance issues are addressed and resolved prior to release.

  • Coordinate with Software Engineering during the development of essential software design control deliverables throughout the design control process.

  • Work closely with the project team to develop software plans, appropriate verifications and validations, for both new design projects and changes to released product.

  • Review project documentation such as software requirement/functional specifications, software architecture, software hazard documentation, software V&V documentation.

  • Perform gap analysis against existing documentation to identify, communicate and help resolve non-compliance issues

  • Create, review, and update software procedures, work instructions and forms with focus on compliance to FDA QSR regulations and recognized international standards.

  • Schedule weekly Change Management meetings and participate in the process to review and approve change requests.

  • Participate in risk management and assessment process.

  • Approve Engineering Change Orders for software when required.

  • Improve quality systems to ensure best practices are utilized.

  • Identify and assist in the resolution of quality-related issues, especially those that impact the quality system processes.

  • Design and execute change control process for on market products.

  • Perform other related duties as assigned.

Budget managed (if applicable)

  • N/A

Internal Networking/Key relationships

  • Quality Engineering; Systems Engineering; Software Engineering; Documentation Control; Regulatory

Skills & Capabilities:

  • Ability to read, analyze and interpret IL procedures, international standards and government regulations

  • Capable of writing technical procedures

  • Ability to represent department in cross-functional interactions

  • Ability to determine and develop an approach to a wide range of issues and problems. Solutions must be thorough, practical and consistent with department and company objectives.

  • Ability to analyze, organize and prioritize work while meeting multiple deadlines

  • Must be able to work as part of a team or as an individual contributor

Min Knowledge & Experience required for the position:

  • Associates Degree plus minimum 4 years of related experience, Bachelor’s Degree plus a minimum 2 years of related experience, Master’s Degree plus typically 1 year of related experience or waiver based on at least 5 years' experience in the software quality environment within the Medical Device industry. Degree should be in a technical discipline such as Engineering or Computer Science.

  • Experience with implementation of ISO 14971.

  • Working knowledge of 21 CFR 820, ISO 13485, and IEC 62304 and other recognized international quality system standards.

  • Experience with Quality/Design Assurance, and Design Control and Software Development initiatives for FDA Class II and Class III medical devices and software as a medical device.

  • Knowledge of FDA QSR requirements.

  • Knowledge of Agile (Scrum) methodology is a plus.

  • Proficiency with personal computer and software packages such as MS Word, Excel and Visio

  • Knowledge of JIRA, Confluence, Cockpit, DOORS and have experience with administrator/management/maintenance on those SW tools is a plus.

  • In-vitro medical device experience is a plus.

International Mobility:

  • Required: No

Travel requirements:

  • Some domestic and international travel may be required

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: 2020-3562

Shift: 1st

Street: 180 Hartwell Road