Quality Engineer I - Med Device Quality & Compliance

Viant Medical Inc.; Town of Orchard Park (NY); Vor Ort; USD 80.000 - 100.000; Vollzeit

Benefits dieser Stelle

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

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

SPC

FMEA

DOE

Root cause analysis

Process validation

Lean Six Sigma

Ausbildung

Bachelor's degree in Engineering/Quality/Manufacturing

CQE certification

Tools

Microsoft Excel

Minitab

Jobbeschreibung

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.