Technical leader of SW Quality within the QA/RA Department. Responsible for developing, applying and implementing methods, tools and practices to achieve product and systems quality goals with regard to SW. Leads quality oversight of SW design, testing, validation and support of software internal to instruments, in business systems applications and customer tools as directed.
Key Accountabilities: • Review and approval of production SW Protocols, Reports and related CO's • Oversight of design and implementation of customer tools and SW applications that interact with IL products in the customer environment • Quality department representative or core team member on new projects and SW upgrade for phase gate support regarding SW requirements, risk, output and validation • Reviews and approves R&D development documents related to embedded SW on new instruments • Supports validations of quality systems SW tools (eRAW, eCAPA, eDHR, etc.) • Acts as independent reviewer on SW related design reviews • Supports/leads internal audits for compliance with IL procedures, Design Controls and regulations • Supports/leads vender audits related to SW • Supports Customer Complaint investigation and response for SW related issues • Oversight of SW related CAPAs
Budget managed (if applicable) N/A
Internal Networking/Key relationships • To be determined based on department needs
Skills & Capabilities: • Proficiency with a personal computer and software packages. • Ability to operate instrumentation and to handle many software components. Possesses strong written and oral communication skills, and able to work in a team environment • Proficient in computer codes (Assembly, C, C++, Java, C#, etc.) found in the development
Min Knowledge & Experience required for the position: • Associates Degree plus typically a minimum of 8 years of related experience; or Bachelor's Degree plus typically 6 years of related experience in SW quality; or Master's Degree plus typically 4 years of related experience in SW quality; or waiver based on experience. Degree should be in a technical discipline such as Chemistry, Math, Physics, Engineering, or Computer Science. • Familiarity with FDA and 18013485 regulations as they pertain to SW development, testing, validation, launch and support. External certifications (Six Sigma, ASQ, etc. helpful)
International Mobility: Required: no
Travel requirements: • Some travel 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
Founded in 1959, Instrumentation Laboratory (IL) is a global leader in the development, manufacturing and distribution of diagnostic solutions for Critical Care, Hemostasis and Patient Blood Management testing in hospitals, at the point-of-care and in the laboratory. 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.