Software Quality Engineering Lead

This is a fully remote position, open to applicants in California, +1 more state.

📋 Description

• Oversee direct reports and manage their medical device software projects to ensure adherence to local procedures and regulatory standards.

• Evaluate project/program software deliverables (such as plans, requirements, specifications, test protocols, test cases, test results, traceability, risk management documents, and reports).

• Provide guidance and leadership for the verification and validation processes of non-product software, product software, software tools, and components.

• Offer expertise in formulating solid software requirements, specifications, detailed design, verification and validation protocols, and planning documentation.

• Collaborate with project/program teams to ensure software deliverables align with company policies, global ISO standards (ISO 13485, ISO 14971, IEC 62304), regulations (e.g., 21 CFR Part 820, 21 CFR Part 11, European Union Medical Device Directive (MDD)/Medical Device Regulation (MDR)), and relevant guidance.

• Represent Quality during the resolution of software-related issues.

• Engage in technical design reviews and project phase assessments.

• Apply risk management knowledge to ensure a risk-based methodology for QMS processes.

• Identify and implement necessary changes to maintain the ongoing suitability and effectiveness of the quality management system, utilizing quality policy, quality objectives, audit results, data analysis, etc.

• Assist with internal audits and external audits conducted by regulatory bodies, as necessary.

⛳️ Requirements

• A Bachelor's degree in Computer Science, Engineering, or a related field, along with 8 years of experience in the job offered or in a Software Quality Engineering Lead-related role will be accepted by the employer.

• Certification as a Software Quality Engineer (CSQE) is mandatory.

• Project Management Professional (PMP) certification is required.

• Telecommuting options may be available.

🏝️ Benefits

• Vacation – 120 hours per calendar year.

• Sick leave – 40 hours per calendar year; for employees residing in Colorado – 48 hours per calendar year; for employees residing in Washington – 56 hours per calendar year.

• Holiday pay, including Floating Holidays – 13 days per calendar year.

• Work, Personal, and Family Time – up to 40 hours per calendar year.

• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child.

• Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year.

• Caregiver Leave – 80 hours within a 52-week rolling period.

• Volunteer Leave – 32 hours per calendar year.

• Military Spouse Time-Off – 80 hours per calendar year.

• This position qualifies for the Company’s long-term incentive program.

• This role is eligible for benefits including medical, dental, vision, and time off, along with any additional benefits outlined in the applicable Collective Bargaining Agreement.