Quality Assurance - Quality Engineer I

Viant • Orchard Park, NY

1d

About The Position

The Quality Engineer I is an early-career role supporting the quality and regulatory compliance of medical device products at Viant’s Orchard Park, New York facility. The role partners with Manufacturing, Engineering, and customer teams and contributes to process validation, continuous improvement, supplier quality, and new product development. It offers the opportunity to develop expertise in medical device regulations, quality systems, and manufacturing processes while helping ensure product safety and reliability.

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.
• Familiarity with supplier quality processes, audits, and corrective action systems.
• 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.

Nice To Haves

• CQE certification.
• Experience with FDA regulations, ISO 13485, and quality management systems.
• Minitab experience.
• 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 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level