Software Quality Engineering Lead

Job Duties

• Manage Direct Reports and oversees their medical device software projects to ensure compliance to local procedures and regulatory requirements.
• Review project/program software deliverables (e.g. plans, requirements, specifications, test protocols, test cases, test results, traceability, risk management documents, reports).
• Provides direction and leadership for verification and validation of non-product software, products software, software tools and components.
• Provide expertise in establishing good software requirements, specifications, detailed design, verification and validation protocols and planning documentation.
• Collaborate with project/program teams to ensure software deliverables comply with company procedures, global ISO standards (ISO 13485, ISO14971, IEC62304), regulations (e.g. 21 CFR Part 820, 21 CFR Part 11, European Union Medical Device Directive (MDD)/ Medical Device Regulation (MDR), and applicable guidance).
• Provide Quality representation during software problem resolution.
• Participate in technical design reviews and project phase reviews.
• Utilize knowledge of risk management to ensure a risk-based approach for QMS processes.
• Identifies and implements any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system using quality policy, quality objectives, audit results, analysis of data, etc.
• Support internal audits and external audits by regulatory agencies, as required.

Requirements

• Employer will accept a Bachelor's degree in Computer Science, Engineering or related field and 8 years of experience in the job offered or in a Software Quality Engineering Lead-related occupation.
• Certified Software Quality Engineer (CSQE) certification required.
• Project Management Professional (PMP) certification required.
• May telecommute.

Benefits

• This position is eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement.