Quality Assurance - Quality Engineer I

About The Site

Located in Orchard Park, New York, our facility supports the development and manufacture of innovative medical device technologies. Team members work in a collaborative environment focused on quality, continuous improvement, and delivering products that enhance patient lives.

About The Role

This is an excellent opportunity for an early-career quality professional looking 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.

In This Role, You Will Have the Opportunity To:

• Support the quality and compliance of innovative medical device products.
• Collaborate with manufacturing, engineering, and customer teams to solve complex challenges.
• Drive continuous improvement initiatives utilizing SPC, FMEA, DOE, and process validation tools.
• Participate in new product introductions and help bring new technologies to market.
• Develop your expertise in regulatory requirements, quality systems, and supplier quality.
• Lead investigations, corrective actions, and efforts that improve product quality and reliability.

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.

Job Requirements

Education

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.

Experience

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.

Knowledge & 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.
• Skills & Competencies
• 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.

Benefits

Benefits effective day one of hire

• 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

Compensation

We offer market competitive compensation. Potential salary range for this role is $80,000 - $100,000 annually. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

Apply Today

Ready to build a rewarding career while helping improve patient lives around the world? Join a team that values innovation, collaboration, and continuous growth. We look forward to learning how your talents can contribute to Viant's mission. Apply today!