Senior Software Quality - Medical Device
Kforce Inc.

Carlsbad, California

This job has expired.


RESPONSIBILITIES:

Kforce has a client in Carlsbad, CA that is seeking a Senior Software Quality (Medical Device). In this role, the Senior Software Quality (Medical Device) role will likely be 100% onsite for the first week or so until the person can get up to speed with all the projects. This role will potentially be a 3/2 split onsite/remote or 50/50 onsite/remote, depending on the needs of the project at the time.Responsibilities:
  • The Senior Software Quality is responsible for Design Quality Assurance for Catheters and Devices containing software and adherence to IEC 62304
  • Partner directly with R&D and other cross-functional team members to contribute Software Quality activities for all software development life cycle activities including risk management, software configuration management, and software problem resolution
  • Support development and testing of product software to meet user and technical requirements and design specifications, while ensuring compliance with FDA and worldwide Regulatory Body regulations and guidance
  • Lead Risk Management/Software FMEA activities and create Software Hazard Analysis (SHA) using a top-down risk approach following ISO 14971 and IEC 62304
  • As a Senior Software Quality, you will perform day to day Software Quality activities to ensure that software and supporting test tools have been Verified and Validated (V&V), demonstrating that the software meets specification requirements and works as intended, per user needs and design requirements
  • Submit, review and approve documents in Document Control system
  • Audit DHF (Design History File) for completeness and compliance
  • The Senior Software Quality will manage Software Change Control to assess and disposition software defects and change requests in collaboration with cross functional teams


REQUIREMENTS:

  • Bachelor's degree in Computer Science, Software Engineering, Information Systems/Technology, or related engineering field with 5+ years of relevant industry experience in software quality engineering; Or Master's degree with a minimum of 3 years of relevant industry experience in software quality engineering
  • Medical Device Software Development/QE experience is required
  • Familiarity with Medical Device Software Development regulations including IEC 62304 and FDA Guidance for software contained in medical devices
  • Quality engineering experience with medical devices containing software (Class II/Class B at minimum and Class III/Class C preferred)
  • Knowledge and experience with Medical Device Quality Systems (ISO 13485 & 21 CFR Part 820) & Risk Management per ISO 14971
  • Experience with Software Human Factors & Usability Engineering
  • General understanding of SAAS, IAAS, and PAAS for Microsoft Azure environments is a plus but not required
  • General understanding of Waterfall & Agile software development methodologies
  • Ability to use electronic systems to manage product Software Development Life Cycle; including Defect Management, Risk Management, Test Management, Software Configuration Management, and Traceability of requirements and test assets
Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

The pay range is the lowest to highest compensation we reasonably in good faith believe we would pay at posting for this role. We may ultimately pay more or less than this range. Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. This range may be modified in the future.

We offer comprehensive benefits including medical/dental/vision insurance, HSA, FSA, 401(k), and life, disability & ADD insurance to eligible employees. Salaried personnel receive paid time off. Hourly employees are not eligible for paid time off unless required by law. Hourly employees on a Service Contract Act project are eligible for paid sick leave.

Note: Pay is not considered compensation until it is earned, vested and determinable. The amount and availability of any compensation remains in Kforce's sole discretion unless and until paid and may be modified in its discretion consistent with the law.

This job is not eligible for bonuses, incentives or commissions.

Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.




This job has expired.

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