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
Anticipated Start Date: November 2 or November 9, 2026

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: $45/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.