Quality Assurance - Quality Engineer I

Viant Medical Inc.; Town of Orchard Park (NY); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) plan with company match

Paid time off and paid holidays

Tuition reimbursement and career dev.

Company-paid life insurance

Pet insurance

Employee discount programs

Home ownership program

Job summary

Viant Medical Inc. in Orchard Park, NY, is hiring a Quality Engineer I to support FDA QSR and ISO 13485 compliant quality systems. You will collaborate with Manufacturing, Engineering, and Quality teams to promote product quality, process validation, and continuous improvement.

Ideal candidates have a BS in engineering or related field, 2+ years in medical devices, and familiarity with SPC, FMEA, and DOE. CQE is a plus; strong problem-solving and communication skills are essential.

Qualifications

• Bachelor's degree in Engineering, Quality, Manufacturing, or related technical field; CQE certification is a plus.
• Minimum 2 years of experience in medical device industry or another regulated manufacturing environment.
• Experience with FDA regulations, ISO 13485, and quality management systems preferred.
• Knowledge of quality engineering principles and tools including SPC, FMEA, DOE, root cause analysis, and process validation.

Responsibilities

• Maintain compliance with FDA QSR 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 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.

Skills

SPC

FMEA

DOE

Root cause analysis

Process validation

Lean Six Sigma

Education

Bachelor's degree in Engineering/Quality/Manufacturing

CQE certification

Tools

Microsoft Excel

Minitab

Job description

Quality Engineer I

Why Join Us?

Are you passionate about quality, problem-solving, and making a meaningful impact? Join Viant and help bring innovative, life-changing medical technologies to patients around the world. As a Quality Engineer I, you will work alongside experienced professionals, gain exposure to cutting-edge manufacturing and quality systems, and play a key role in ensuring the safety and reliability of products that improve lives. At Viant, we are committed to your growth and success because We're In It For Life.

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.

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.