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About the Role
This role offers an excellent opportunity for an early-career quality professional to expand their experience in the medical device industry. You will partner with cross-functional teams across Manufacturing, Engineering, and Quality while developing expertise in regulatory compliance, process validation, continuous improvement, and new product development. Every day offers opportunities to learn, contribute, and make a difference.
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 utilizing tools such as 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.
Requirements
- Minimum 2 years of experience in the medical device industry or another regulated manufacturing environment.
- Minimum 2 years of experience supporting new product development and quality engineering activities.
- Experience with FDA regulations, ISO 13485, and quality management systems preferred.
Skills
- 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; Minitab experience preferred.
- Familiarity with supplier quality processes, audits, and corrective action systems.
- Experience with Lean Manufacturing or Six Sigma methodologies is a plus.
- 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 while collaborating effectively across departments.
Location
- Orchard Park, New York
Work Type
- Onsite
Experience Level
- Early-career
- Minimum 2 years
Education Level
- Bachelor's degree in Engineering, Quality, Manufacturing, or a related technical or scientific field, or equivalent combination of certification and experience.
- CQE certification is a plus.
Salary/Compensations
- $80,000 - $100,000
Benefits
- Medical, dental, and vision coverage
- 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
About the Company
- Viant is a global medical device partner providing design, development, manufacturing, and assembly services through capabilities in materials, plastics, metals, extrusion, and automation.
- With nearly 6,000 employees across 24 locations worldwide, we help bring innovative healthcare technologies to market efficiently and reliably.