Quality Engineer (Software)

Job Title: Quality Engineer (Software)

Company: Novozen Health Care

Location: Massachusetts

Employment Type: Contract — W2

Duration: 14+ months

Hours per Week: 40

Job Responsibilities

• Support medical device software development teams in applying design controls and IEC 62304 software lifecycle practices.
• Draft, review, and maintain system- and software-level requirements and specifications.
• Maintain traceability between requirements, risk controls, design outputs, and verification and validation testing.
• Participate in design and documentation reviews, identify gaps, and support complete Design History Files and regulatory submission records.
• Support software risk assessments by reviewing product features and system requirements.
• Collaborate with Software, Systems, and Quality teams to improve documentation and development processes.

Required Qualifications

• Bachelor’s degree in a relevant technical field.
• At least 3 years of experience supporting regulated software or systems development.
• Working knowledge of IEC 62304, design controls, and requirements traceability.
• Strong technical documentation, organizational, and cross-functional communication skills.
• Candidates with 3–5 years of relevant experience are preferred; candidates with up to 10 years may be considered.
• Medical device experience, familiarity with Jama, Polarion, or DOORS, and exposure to FDA requirements, ISO 13485, ISO 14971, or verification documentation are preferred.

Pay Scale

Anticipated hourly pay: $40/hr- $50/hr on W2 .

Benefits

Employees hired into this position are eligible for the following benefits, subject to applicable plan terms and eligibility requirements:

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO is provided other than that required by applicable state and local laws.