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
Mandatory skills:
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
The pay range that the employer in good faith reasonably expects to pay for this position is $43.92/hour - $68.62/hour. Our benefits include medical, dental, vision and retirement benefits. Applications will be accepted on an ongoing basis.
Tundra Technical Solutions is among North America’s leading providers of Staffing and Consulting Services. Our success and our clients’ success are built on a foundation of service excellence. We are an equal opportunity employer, and we do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability, genetic information, or other applicable legally protected characteristic. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Unincorporated LA County workers: we reasonably believe that criminal history may have a direct, adverse and negative relationship with the following job duties, potentially resulting in the withdrawal of a conditional offer of employment: client provided property, including hardware (both of which may include data) entrusted to you from theft, loss or damage; return all portable client computer hardware in your possession (including the data contained therein) upon completion of the assignment, and; maintain the confidentiality of client proprietary, confidential, or non-public information. In addition, job duties require access to secure and protected client information technology systems and related data security obligations.
