Senior Software Quality Engineer

MAIN PURPOSE OF THE ROLE

This is an ONSITE role based out of Sylmar, CA

This position is responsible for software quality, compliance, and design assurance activities associated with cloud-based medical device applications and supporting infrastructure. This role ensures software systems are developed, verified, validated, and maintained in compliance with applicable medical device regulations, quality system requirements, cybersecurity standards, and design control processes.

The position works closely with Development, Systems, DevOps, Product Management, Clinical Affairs, Cybersecurity, and Regulatory Affairs team to deliver secure, reliable, and compliant software solutions that support patient care and business objectives.

Main Responsibilities

• Support all phases of the Software Development Lifecycle (SDLC), including requirements development, architecture, implementation, verification, validation, release management, post-market support, and continuous improvement.
• Review software lifecycle deliverables, participate in design and release reviews, and ensure software development activities align with Design Control requirements, software lifecycle standards, and risk management processes throughout the product lifecycle.
• Participate in change impact assessments by evaluating the impact of software changes on product requirements, risk controls, testing, system performance, and regulatory compliance.
• Assist in the completion and maintenance of risk management files, focused on software and system related risks.
• Lead quality and compliance assessments for software defects and product issues, ensuring appropriate risk evaluations, impact assessments, and escalation processes are executed to support timely customer communications, regulatory reporting evaluations, and corrective action activities
• Evaluate verification and validation strategies, test coverage, traceability, and defect management activities to ensure requirements, risk controls, cybersecurity considerations, and intended use are adequately addressed and supported by objective evidence for compliant product releases
• Support internal audits, external audits, regulatory inspections, and compliance assessments by providing objective evidence and subject matter expertise related to software lifecycle and design control processes.
• Drive continuous improvement activities and support investigations, CAPAs, and compliance initiatives related to software products and processes.
• Serve as a software compliance and design assurance subject matter expert, partnering with cross-functional teams to ensure quality and compliance considerations are integrated throughout product development and maintenance activities.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Qualifications

Education

• Bachelors Degree (± 16 years) in an Engineering or Technical Field

(OR)

• An equivalent combination of education and work experience

Experience/Background

• Minimum 7 years of Software Quality Engineering experience.
• Detailed knowledge of IEC 62304, ISO 14971, ISO 13485, FDA Design Controls, FDA Computer Software Assurance (CSA), Medical Device Cybersecurity Guidance, Software Validation Principles, IEEE 1012.
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Advanced Information Technology and data mining skills.
• Prior medical device experience preferred. ASQ CSQE certification desired.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel approximately 5-25%, including internationally.

The base pay for this position is $90,000.00 – $180,000.00. In specific locations, the pay range may vary from the range posted.