Vaco by Highspring · 16 hours ago
Quality Engineer
Hudson, NH
Full-time
Onsite
Entry, Mid Level
$31/hr - $49/hr
2+ years expVaco by Highspring is seeking a Quality Engineer who can bring strong technical expertise and problem-solving skills to a fast-paced product development and manufacturing environment. The role involves leading validation and qualification activities for complex products, driving risk management, and ensuring compliance with industry standards.
Staffing & Recruiting
Hiring Manager
Madison Komara
Responsibilities
Lead validation and qualification activities for complex products through new product introduction (NPI) and transfer workflows
Act as the lead Quality Engineer on development projects, guiding Design History File (DHF) and Device Master Record (DMR) documentation and planning product builds
Drive risk management activities, develop risk documentation (e.g., PFMEAs), and implement mitigation strategies
Lead root-cause investigations using structured problem-solving tools and verify effectiveness of corrective actions
Develop and improve test methods and support equipment, process, and product validation efforts
Create, review, and maintain process control plans and quality documentation aligned with regulatory requirements
Support design controls in compliance with ISO 13485 and 21 CFR 820, including verification, validation, and related design review activities
Partner with engineering, operations, customers, and suppliers to transition new products into manufacturing and sustain ongoing production processes
Improve and standardize manufacturing process instructions and quality procedures; provide training when needed
Develop metrology tools and oversee Gage R&R studies to ensure accurate measurement systems
Review nonconformances, approve dispositions, and support corrective and preventive action (CAPA) activities
Analyze production and validation data to identify trends and opportunities for process improvement
Support supplier quality tasks, including communication with customer quality teams and supplier qualification when required
Assist with troubleshooting production issues and supporting manufacturing and development processes
Ensure calibration and maintenance procedures are followed for equipment used in validation and production
Prepare deviations, change notices, validation protocols, and related quality documentation
Qualification
Required
2+ years of Quality Engineering experience in medical device manufacturing, a start-up environment, or comparable engineering role
Bachelor's degree or equivalent experience
Working knowledge of ISO 13485, 21 CFR 820, and quality system regulations
Experience creating technical and quality-related documentation
Strong communication, technical writing, and interpersonal skills when interacting with customers and suppliers
Familiarity with statistical analysis tools such as Minitab; experience with Gage R&R is a plus
Ability to support supplier audits, qualification activities, and ongoing quality communication
Benefits
Discretionary bonuses
Medical, dental, and vision benefits
401(k) retirement plan
Company
Vaco by Highspring
Vaco is the Talent Solutions division of Highspring, a leading global professional services organization.
5001-10000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase