Senior Software Quality Assurance Engineer

Job Title: Senior Software Quality Assurance Engineer

Location: Andover, MA

Position Type: Contract

Duration: 6 / 12 Month

Work Type: Onsite

Rate: Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Job Description:

As a Senior Software Quality Assurance Lead - IDE & PMA (SDLC Governance) for our medical device manufacturer client in the Greater Boston region, you will be responsible for ensuring end to end software quality across the development lifecycle for systems supporting IDE clinical investigations and PMA submissions.
Working onsite and reporting to the Head of Quality, you will govern software quality practices, ensure compliance with FDA regulations, and proactively identify gaps or inconsistencies in existing SOPs.

Key Responsibilities
In this role you will play a key role in:

• Owning software quality governance across the SDLC, ensuring readiness from requirements through V&V and release for IDE and PMA

• Reviewing and challenging existing SOPs and quality processes to identify gaps, inconsistencies, or misalignment with regulatory expectations

• Ensuring end to end traceability across user needs, requirements, risk controls, and verification/validation activities

• Governing software design controls and ensuring completeness and audit readiness of DHF deliverables

• Supporting IDE clinical study readiness including configuration management, version control, and change impact assessments

• Overseeing risk based software V&V activities and ensuring validation evidence is complete and defensible for regulatory submissions

• Collaborating cross functionally (software, systems, regulatory) to ensure quality requirements are defined and met

• Supporting PMA submissions, audits, and FDA interactions by providing software quality documentation and SMEs support

What are the Mandatory skills and skill proficiencies required for this position?

• 10+ years of experience in software quality assurance within regulated environments (medical device preferred)

• Experience supporting IDE, PMA, or similar regulatory pathways with understanding of clinical evidence requirements

• Strong understanding of SDLC and design controls in regulated environments (e.g., traceability, DHF)

• Proven experience reviewing and improving SOPs or quality processes for regulatory compliance

• Hands on experience with software verification and validation using risk based approaches aligned with FDA expectations

• Familiarity with FDA regulations and standards (e.g., 21 CFR 820, 812, 814)

• Experience with test management, defect tracking, and quality documentation tools

• Strong analytical, documentation, and stakeholder communication skills with ability to influence quality decisions

ABOUT Ztek:

Website:

Ztek Consulting Inc is a minority- and woman-owned business enterprise that leverages a unique blend of human talent, machine learning algorithms, and artificial intelligence to provide customized talent management solutions for clients. Ztek's diversity-focused hiring models have proven successful, particularly in hiring veterans. The company's veteran-focused hiring and deployment program, Z-V.E.T, matches skilled veterans with clients' needs in various areas.

Disclaimer:

Ztek is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Ztek is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates.

If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at  Please indicate the specifics of the assistance needed. Ztek encourages all interested and qualified candidates to apply for employment opportunities. Ztek does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. 1324b.