Viant Medical · 1 day ago
Quality Assurance Engineer III
Chicopee, MA
Full-time
Onsite
Mid, Senior Level
$93K/yr - $115K/yr
5+ years expViant Medical is a global medical device design and manufacturing services provider committed to delivering high-quality, life-enhancing medical technology. The Quality Assurance Engineer III will ensure adherence to Quality System requirements in medical device manufacturing and lead various quality improvement initiatives.
Cosmetic SurgeryHealth CareManufacturingMedical
Responsibilities
Adheres to Viant Core Values and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements
Auditing experience with regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality. Front room experience desired
Monitors manufacturing of assigned products, assuring compliance with DMR and quality system requirements and assuring complete and correct Device History Records are maintained
Leads site process and product improvement initiatives
Participates in the development, completion, and maintenance of risk analyses
Leads the generation and completion of protocols and reports for product, process, and test method validations
Collaborates with Manufacturing Engineers to review processes for new and existing products and supports the coordinate of process validations and capability studies
Supports the development various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, implementation, and training of Incoming, In-Process, Manufacturing instructions, and Final Inspection procedures
Supports the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence
Conducts root cause complaint investigations and remediation recommendations as needed
Key team member in CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis
Assists with product transfers
Qualification
Required
Ability to read and write in English
Self-motivated with strong ability to adapt to change
Ability to work cross-functionally and as part of a project team
Ability to read and interpret technical drawings
Proficiency in statistical tools (e.g., Gage R&R, Capability Analysis, ANOVA); Minitab experience is a plus
Experience in ISO 13485 industry
Ability to conduct root cause investigations using techniques such as FMEA, Fishbone, 5 Why, and 8D
Extensive experience with Process Validation (IQ, OQ, PQ, TMV).(Must)
Detail-oriented with strong organizational skills
Experience in audit processes (internal or external audits)
BS degree in a related discipline or High School Diploma with 10+ years of relevant experience
5–8 years of relevant experience
Experience in the medical device industry
Preferred
Certified ISO Auditor training
Experience with Quality Management System (IQMS)
Advanced proficiency with Microsoft programs
Experience applying statistical tools and using Minitab
Familiarity with process validation and quality methodologies
Benefits
Medical, dental, and vision benefits-effective date of hire!
Company-paid life insurance and disability benefits
Generous Paid time off and 10 paid Holidays
401k Plan with Company Match
Tuition Reimbursement
Voluntary Universal Life and Long-Term Care
Voluntary Legal Plan
Pet Insurance
Home Ownership Program
Company
Viant Medical
Viant Medical is a manufacturer of precision molded plastic and rubber components.
5001-10000 employees
H1B Sponsorship
Viant Medical 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 (6)
2024 (13)
2023 (11)
2022 (6)
2021 (7)
2020 (5)
Funding
Current Stage
Late StageTotal Funding
unknown2016-12-07Private Equity
2008-06-17Series Unknown
Leadership Team
Alton Shader
CEO
Nino Gilarde
Chief Financial Officer
Recent News
Morningstar.com
2025-09-25
Medical Product Outsourcing
2025-04-23
Company data provided by crunchbase