Vaxess Technologies · 12 hours ago
Quality Engineer I/II
Woburn, MA
Full-time
Onsite
Mid, Senior Level
$62K/yr - $88K/yr
3+ years expVaxess Technologies is developing next-generation therapeutics on a novel micro-array patch platform. The Quality Engineer I/II will support Quality Assurance activities for combination product programs, focusing on medical device design controls, risk management, and cGMP compliance.
BiotechnologyHealth CareMedical
Responsibilities
Support quality oversight of Vaxess combination product(s) to ensure compliance with safety, efficacy, and regulatory requirements
Administer and support the Quality Management System (QMS) in accordance with ISO 13485, 21 CFR 820, 21 CFR Part 4 (Combination Products), and applicable FDA and international regulations
Provide quality support for Design Control activities, including Design History File (DHF) maintenance, design reviews, Design Verification and Validation (DVV), and design changes
Support risk management activities, including development and maintenance of risk analyses (e.g., FMEA, hazard analyses) and linkage to design and process controls
Support process validation and qualification activities, including test method validation (TMV), process validation (PV), and equipment qualification, as applicable to Phase I and GMP-ready manufacturing
Participate in Material Review Board (MRB) activities, including nonconformance assessment, disposition, and documentation
Perform quality review and approval of batch records, executed manufacturing records, analytical data collection forms, test records, and technical or experimental reports
Collaborate in supplier quality management activities, including supplier qualification, auditing, monitoring, change evaluation, and periodic requalification
Author, review, and revise quality documentation, including SOPs, work instructions, test methods, protocols, reports, forms, and specifications
Support preparation, review, and organization of quality data and documentation for regulatory submissions and inspections
Contribute to continuous improvement initiatives within the QMS, including CAPA, deviation investigations, and quality metrics
Qualification
Required
Quality Engineer I: Minimum of 3 years of experience in Quality Assurance or Quality Engineering within a cGMP-regulated medical device or combination product environment
Quality Engineer II: Typically 4–5 years of progressive quality experience in medical devices, pharmaceuticals, biologics, or combination products
Working knowledge of ISO 13485 and FDA medical device Quality System Regulations (21 CFR 820); familiarity with combination product requirements strongly preferred
Strong written and verbal communication skills, with the ability to clearly document technical and quality concepts
Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)
Preferred
Experience supporting early-phase (preclinical to Phase I) product development is highly desirable
Experience with design controls, risk management (FMEA), and validation activities preferred
Experience reviewing GMP documentation such as batch records, test methods, protocols, and reports
Company
Vaxess Technologies
Vaxess Technologies engages in developing biomedical innovations with a focus on improving access to vaccines.
11-50 employees
H1B Sponsorship
Vaxess Technologies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2022 (3)
Funding
Current Stage
Growth StageTotal Funding
$95.87MKey Investors
RA Capital ManagementNational Science FoundationThe Engine
2025-04-09Series Unknown· $9M
2024-05-22Series Unknown· $12M
2023-09-13Series Unknown· $9M
Leadership Team
K
Kathryn Kosuda
Co-founder, VP of Research & Development
Livio Valenti
Co-Founder, Senior VP of Strategy, BD and Operations
Recent News
EIN Presswire
2025-06-25
vcnewsdaily.com
2025-04-26
Company data provided by crunchbase