Quality Engineer I
About the SiteLocated 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 RoleThis 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 RequirementsEducationBachelor'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.
ExperienceMinimum 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.
BenefitsBenefits 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
CompensationWe 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 TodayReady 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!
