Supplier Quality Software Engineer

Manages supplier quality for software and software-embedded components to meet SDLC, regulatory, and performance standards.

Requirements

• Bachelor’s degree in Software Engineering, Computer Science, Electrical Engineering, or related field

• 3+ years in software quality, software validation, or supplier quality engineering

• Strong knowledge of SDLC and software validation practices

• Working familiarity with ISO 13485, ISO 9001, IEC 62304, and FDA software guidance

• Experience collaborating with suppliers or external technical partners

• Auditing and documentation proficiency

Preferred Skills

• Experience in medical device, pharmaceutical, or highly regulated manufacturing

• Knowledge of ISO 14971 risk management and software/cybersecurity compliance

• Domestic and international supplier audit experience

• Six Sigma Green Belt or equivalent process improvement certification

Responsibilities

• Own supplier quality activities for software and software-enabled components across the SDLC

• Define and enforce supplier quality and compliance requirements aligned to ISO 13485, ISO 9001, IEC 62304, FDA guidance, and internal QMS

• Plan, execute, and report supplier audits; track findings to closure

• Review supplier software development/validation deliverables, risk analyses, and configuration management artifacts

• Assess and approve software change requests; ensure traceability from requirements through verification/validation

• Drive issue containment, CAPA/SCAR actions, and effectiveness checks with suppliers

• Establish incoming acceptance criteria; monitor supplier KPIs and quality plans

• Partner with engineering to qualify new suppliers and software components; support design transfer and sustaining changes

• Maintain compliant documentation, records, and objective evidence for inspections and audits

Pay Details: $55.00 to $60.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.