AuST Group ยท 1 day ago
Quality Engineer
West Valley City, UT
Full-time
Onsite
Mid, Senior Level
3+ years expAuST Manufacturing is a rapidly-growing medical device design house and manufacturing facility, with an innovative and energetic team that is committed to providing high-quality products to our customers and patients. They are seeking a Quality Engineer (QE) in the Quality Control Department to support and improve inspection, testing, and quality control processes, ensuring compliance with regulatory requirements and internal quality standards for medical devices.
Health CareManufacturingMechanical DesignMedical Device
Responsibilities
Support IQC and FQC activities, including attribute and variable inspections, sampling plans, and inspection executions
Develop, improve, standardize, and maintain inspection methods, test methods, and work instructions. Train inspectors on proper inspection techniques and acceptance criteria
Initiate, investigate, and document Nonconformance Report (NCRs) and support Material Review Board (MRB) activities, including data analysis and disposition documentation
Analyze inspection data, defect trends, yields, and scrap. Apply SPC tools such as control charts and Capabilities to support process monitoring and improvement
Support validation activities including IQ, OQ, PQ, Test Method Validation (TMV), Gage R&R, and software or spreadsheet based tool validation
Support camera-based or automated inspection systems
Other duties as assigned
Integrate quality into manufacturing processes as a value added (real-time) support function, performing root cause analysis, driving data-based continuous quality improvements, and building strong customer relationships
Ensure the successful integration of quality assurance, risk mitigation, and regulatory compliance into device design, development, and manufacturing processes throughout the product lifecycle
Participates in design control and evaluates changes to design and/or manufacturing process for impact to DHF. Leads and executes activities to close any gaps, such as additional verification testing or updates to risk documentation
Assists with product and process risk assessment activities, including hazard analysis and design/process failure modes & effects analysis (DFMEA/PFMEA)
Participates in product and process qualification and evaluation activities not limited to but including complaint investigation, first article, engineering studies, gage R&R, regression analysis, SPC, and DOE
Develops and implements methods for sampling, inspection, defect recognition, product testing and evaluation, and SPC trending utilizing statistical, engineering and quality knowledge
Support the timely handling of investigations, risk assessments, deviations, NCRs and CAPAs
Support internal and external audits as a device and QMS Subject Matter Expert
Leadership and mentoring responsibility for promoting and implementing best in class Quality Management Systems, manufacturing processes, statistical techniques, and QMS software solutions
Qualification
Required
Bachelor's degree in Engineering (Mechanical Engineering preferred)
1-3 years of experience in a quality, manufacturing, or regulated industry role
Experience initiating and managing NCRs in a regulated manufacturing environment (medical device preferred)
Ability to improve, standardize, and train inspection methods for IQC and FQC
Strong data analysis and statistical skills
Working knowledge of SPC concepts (control charts, Cp/Cpk)
Strong technical writing skills for protocols, reports, and documentation
Strong attention to detail and ability to work cross-functionally
Bachelor's degree in a scientific or engineering field is required
Minimum 3 years' experience in a quality engineering role in the medical device industry, or a related industry with manufacturing & assembly processes
Excellent written and verbal communication skills
Proficiency with standard office productivity suite and data analysis software, LMS and eQMS software familiarity is a plus
High level of competence in statistical techniques, control charts, sampling plans, quality costs, design of experiments, correlation, regression, analysis of variance, probability, etc
Experience in medical device design control, risk management, validation, and product lifecycle
Experience with FDA GMP practices, CAPA and non-conforming material processes
Working knowledge and application of device regulations, including 21 CFR 820, ISO 13485, and ISO 14971. Knowledge of MDSAP, EU MDD/MDR a plus
Ability to manage multiple projects within various disciplines, in a fast-paced environment
Self-motivated and capable of working cross-functionally with minimal supervision
Demonstrated ability to assess and provide technical, statistical, and quality guidance throughout the organization to ensure high quality, compliant products
Must be detail oriented with strong leadership skills and excellent interpersonal, collaboration and communication skills
Preferred
Supplier quality experience
Leading MRB experience
Vision system programming experience (e.g., Metrology M3 or similar)
Validation experience
Software validation experience
Familiarity with camera-based or automated inspection systems
Python or similar programming skills for data analysis or automation
ASQ CQE preferred
Benefits
401(k)
401(k) matching
Dental insurance
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Vision insurance
Company
AuST Group
AuST is a medical device design, development, and manufacturing firm specializing in minimally invasive medical devices.
201-500 employees
H1B Sponsorship
AuST Group 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 (1)
2024 (1)
Funding
Current Stage
Growth StageLeadership Team
Christian S. Eversull
Founder & Principal
Company data provided by crunchbase