Software Quality Engineering Lead

Experience Required

8 years of experience in the job offered or in a Software Quality Engineering Lead-related occupation

Minimum Education Required

Bachelor's

Compensation

$187,000.00 - $207,000.00 / Yearly

Hours Per Week

40

Number Of Positions

1

Shift

First Shift (Day)

Job Description

Employer: Auris Health, Inc.

Job Title: Software Quality Engineering Lead

Job Code: A011.5804.12

Job Location: New Brunswick , NJ

Job Type: Full-Time

Rate of Pay: $187,000 - $207,000/year

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 deliverable 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.

Apply online at

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation - 120 hours per calendar year. Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado - 48 hours per calendar year; for employees who reside in the State of 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 in a 52-week rolling period - 10 days. Volunteer Leave - 32 hours per calendar year. Military Spouse Time-Off - 80 hours per calendar year.

Place of Work

Remote

Requisition ID

A011.5804.12

Job Type

Full Time