Software Quality Engineer

PhilipsCambridge, MA
1d$100,000 - $140,000Onsite

About The Position

Software Quality Engineer In this role you Are responsible for playing a pivotal role in developing, maintaining, and managing comprehensive software quality documentation. Your role: • Facilitates the development, maintenance, and management of comprehensive software quality documentation, including Software Requirement Specifications (SRS), ensuring they are accurate, up-to-date, and fully compliant with relevant standards and regulatory requirements throughout the software lifecycle, working under limited supervision. • Leads the assessment of software designs, including reviewing test and performance data, to ensure they meet quality, safety, and regulatory standards, while identifying and addressing quality engineering deficiencies to embed quality within the design. • Conducts in-depth root cause analysis for software quality issues, employing problem-solving techniques to resolve deficiencies and improve software design processes, ensuring that quality is integral to the development process. • Validates key software design inputs such as usability, reliability, performance, localizability, safety, privacy, and cost to ensure they meet customer and regulatory requirements, supporting the delivery of high-quality software products. • Provides effective oversight of the execution of software quality plans and associated risk management activities throughout the software lifecycle, ensuring that all design-related activities are managed according to defined processes.

Requirements

  • Bachelor's / Master's Degree in Computer Science, Computer Applications or equivalent.
  • 2+ years of experience with Bachelor's in areas such as Software Quality Engineering, Design Quality Management, CAPA Methodologies, Product Quality.
  • US work authorization is a precondition of employment.
  • For this position, you must reside in or within commuting distance to Cambridge MA.

Nice To Haves

  • Prefer experience in applying 21 CFR 820, ISO 13485, IEC 14971 and IEC 62304 and working knowledge with IEC 60601 and other relevant medical device standards.

Responsibilities

  • Facilitates the development, maintenance, and management of comprehensive software quality documentation, including Software Requirement Specifications (SRS), ensuring they are accurate, up-to-date, and fully compliant with relevant standards and regulatory requirements throughout the software lifecycle, working under limited supervision.
  • Leads the assessment of software designs, including reviewing test and performance data, to ensure they meet quality, safety, and regulatory standards, while identifying and addressing quality engineering deficiencies to embed quality within the design.
  • Conducts in-depth root cause analysis for software quality issues, employing problem-solving techniques to resolve deficiencies and improve software design processes, ensuring that quality is integral to the development process.
  • Validates key software design inputs such as usability, reliability, performance, localizability, safety, privacy, and cost to ensure they meet customer and regulatory requirements, supporting the delivery of high-quality software products.
  • Provides effective oversight of the execution of software quality plans and associated risk management activities throughout the software lifecycle, ensuring that all design-related activities are managed according to defined processes.

Benefits

  • Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.
© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service