Quality Assurance - Quality Engineer I
About The Position
Viant is seeking an early-career Quality Engineer I to support the quality and compliance of medical device products at its Orchard Park, New York facility. The role partners with Manufacturing, Engineering, and customer teams, while building expertise in regulatory compliance, process validation, continuous improvement, supplier quality, and new product development. The Quality Engineer helps ensure product safety, reliability, and quality and contributes to bringing new technologies to market. The position supports compliance with FDA Quality System Regulations and ISO 13485, quality-system activities, customer inquiries, training, new product development and launches, and supplier quality. It also leads or supports investigations, nonconforming material disposition, measurement system analyses, calibration, and continuous improvement using tools such as SPC, FMEA, DOE, and process validation.
Requirements
- Bachelor's degree in Engineering, Quality, Manufacturing, or a related technical or scientific field, or an equivalent combination of certification and experience.
- At least 2 years of experience in the medical device industry or another regulated manufacturing environment.
- At least 2 years of experience supporting new product development and quality engineering activities.
- Knowledge of quality engineering principles and tools, including SPC, FMEA, DOE, root cause analysis, and process validation.
- Proficiency with Microsoft Excel and statistical analysis software.
- Strong analytical and problem-solving skills.
- Excellent verbal and written communication abilities.
- Ability to manage multiple priorities in a fast-paced environment.
- Ability to work independently and collaborate effectively across departments.
Nice To Haves
- CQE certification.
- Experience with FDA regulations, ISO 13485, and quality management systems.
- Minitab experience.
- Familiarity with supplier quality processes, audits, and corrective action systems.
- Experience with Lean Manufacturing or Six Sigma methodologies.
Responsibilities
- Maintain compliance with FDA Quality System Regulations and ISO 13485 requirements.
- Participate in internal audits, management reviews, and quality system activities.
- Support customer quality and regulatory inquiries.
- Develop and deliver training related to quality systems and quality control activities.
- Provide quality engineering support for new product development and product launches.
- Lead or support continuous improvement activities using SPC, FMEA, DOE, and process validation.
- Develop inspection, testing, and evaluation methods to improve product quality and reliability.
- Perform measurement system analyses and support calibration programs.
- Lead investigations and disposition activities for nonconforming materials and quality issues.
- Support supplier qualification, audits, corrective actions, and ongoing supplier quality activities.
Benefits
- Medical, dental, and vision coverage effective day one of hire.
- 401(k) plan with company match.
- Generous paid time off and paid holidays.
- Low-cost nutrition and mental health visits.
- Tuition reimbursement and career development programs.
- Company-paid life insurance.
- Access to individualized financial planning.
- Pet insurance.
- Employee discount programs.
- Home ownership program.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
