ET
US_East | QA / Quality Engineer_L4
Accepting applicationsExpedite Talent Solutions · Andover, MN
Full-Time Mid_senior aiateddr
Posted
1d ago
Category
Test
Experience
Mid_senior
Country
United States
"Possible 3 Month CTH | No Fees | Do Not Re-Post| Confidential
TMR ID: J7TQQH
Role: Senior Software Quality Assurance Engineer
Work location: Andover, MA
Background and Meet and Greet: MANDATORY
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
"
The following details must accompany your submission:
First Name, Middle name, and Last Name:
City and State:
Open to Relocate?
Rate:
Availability:
Phone #:
Mobile #:
Email address:
Visa type:
Visa Expiration Date:
Hiring Status:
MiguelAngel Buonafina - ERM
North America
Tel.: +***"
Show more Show less
TMR ID: J7TQQH
Role: Senior Software Quality Assurance Engineer
Work location: Andover, MA
Background and Meet and Greet: MANDATORY
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
"
The following details must accompany your submission:
First Name, Middle name, and Last Name:
City and State:
Open to Relocate?
Rate:
Availability:
Phone #:
Mobile #:
Email address:
Visa type:
Visa Expiration Date:
Hiring Status:
MiguelAngel Buonafina - ERM
North America
Tel.: +***"
Show more Show less