Quality Engineering Manager jobs in United States
cer-icon
Apply on Employer Site
company-logo

Viant Medical ยท 3 hours ago

Quality Engineering Manager

Viant Medical is a global medical device design and manufacturing services provider committed to integrity and teamwork. The Quality Engineering Manager oversees all aspects of the quality systems process in a regulated medical device environment, providing strategic leadership for quality assurance and regulatory programs while managing a team of over 20 associates.

Cosmetic SurgeryHealth CareManufacturingMedical
check
H1B Sponsor Likelynote

Responsibilities

Support and uphold Viant Values: Customer Oriented, Integrity, Servant Leadership, Own It, Teamwork, and Be Agile
Provide strategic leadership for all quality assurance and regulatory programs, ensuring continuous improvement and compliance with FDA, ISO 13485, and customer requirements
Lead the design, implementation, and maintenance of systems for document control, training, corrective and preventive action, discrepancy handling, complaint handling, product release, and environmental monitoring
Review and approve quality system documentation; develop and maintain procedures for QA and regulatory functions
Collaborate with plant leadership and corporate quality to drive adherence to processes and achieve KPIs
Manage quality engineering support and indirect inspection teams to improve efficiency and resolve root causes
Interact with customers and suppliers on all quality matters, ensuring strong relationships and satisfaction
Handle direct selection, training, and development of quality personnel; coach and mentor team members
Oversee internal/external audits, CAPA programs, and implement corrective actions to improve product quality
Communicate and act on revisions, validations, and quality-related requirements; ensure robust QMS and customer satisfaction
Manage and communicate all quality-related information, including revisions, validations, audits, and customer requirements
Interpret and implement corrective actions to address product quality issues as requested by customers
Maintain a robust Quality Management System that meets all FDA, ISO 13485 and customer requirements
Perform other duties as needed

Qualification

Quality AssuranceRegulatory AffairsISO 13485FDA ComplianceCMM ProgrammingStatistical AnalysisOracle ProficiencyPower BITeam DevelopmentBlueprint InterpretationMS365 ProficiencyLeadershipCommunication SkillsProblem Solving

Required

Bachelor's degree in Engineering, Quality, or related field
5+ years of experience in Quality Assurance and Regulatory Affairs within medical device manufacturing or any regulated industry (Automotive or Aerospace)
Experience in precision machining and/or metal processing (Must)
Strong knowledge of ISO 13485, FDA, and Corrective Action Plans processes
Experience with internal/external audits and maintaining a robust Quality Management System
Knowledge of CMM programming and inspection systems
Ability to read and interpret blueprints and technical drawings
Proficiency in MS365 applications (Word, Excel, PowerPoint)
Experience Oracle and IQS proficiency (Required)
Experience and knowledge with statistical systems as Minitab for statistical analysis

Preferred

Experience with Power BI (user level)

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

twittertwittertwitter
company-logo
Viant Medical is a manufacturer of precision molded plastic and rubber components.

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 Stage
Total Funding
unknown
2016-12-07Private Equity
2008-06-17Series Unknown

Leadership Team

leader-logo
Alton Shader
CEO
linkedin
leader-logo
Nino Gilarde
Chief Financial Officer
linkedin
Company data provided by crunchbase