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Software Quality Engineer

Roles & Responsibilities

  • Bachelor's or Master's degree in Computer Science, Computer Applications or equivalent
  • 3+ years of experience in Software Quality Engineering, Design Quality Management, CAPA Methodologies, Product Quality
  • Experience applying 21 CFR 820, ISO 13485, IEC 14971 and IEC 62304; working knowledge of IEC 60601 and other relevant medical device standards
  • Ability to meet physical, cognitive and environmental job requirements for an office/remote position

Requirements:

  • 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

Job description

Job Title

Software Quality Engineer

Job Description

Design Quality Engineer SW

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.
 

You're the right fit if:

  • Bachelor's / Master's Degree in Computer Science, Computer Applications or equivalent.
  • 3+ years of experience with Bachelor's in areas such as Software Quality Engineering, Design Quality Management, CAPA Methodologies, Product Quality.
  • 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.
  • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position. 

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office role.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

Philips Transparency Details

The pay range for this position in Cambridge, MA is $100,000 to $140,000 Annually. 

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.    

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered.  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.  Details about our benefits can be found here

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. 

Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. 

Company relocation benefits will not be provided for this position.  For this position, you must reside in or within commuting distance to Cambridge MA.

#LI-PHI

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates.  Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

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