Medical QA Engineer - ISO 13485, Flexible Hours

ADP, Inc.; Lewis Center (OH); Sur place; USD 90 000 - 110 000; Plein temps

Avantages offerts par ce poste

Medical, dental, and vision insurance

Company paid life insurance

Company matched 401k plan

Quarterly incentive bonuses

Flexible hours

Paid time off

PAID plant shutdown in December

Résumé du poste

Abrasive Technology is seeking a Quality Assurance Engineer for Medical products in Lewis Center, OH. You will drive quality in the medical manufacturing environment, collaborate with engineering, manufacturing, and operations, and focus on regulatory compliance, continuous improvement, and product performance.

The role requires strong root cause analysis, auditing, and cross-functional teamwork to meet ISO and medical device standards while delivering high-quality medical components.

Qualifications

• BS degree in engineering or engineering technology or equivalent experience.
• Minimum 5 years of quality engineering experience.
• Experience in medical device market and applying quality requirements in a medical device environment.

Responsabilités

• Ensure compliance with ISO 9001, ISO 14971, ISO 13485 and MDSAP for the department.
• Manage and improve Cost of Quality for the medical business segment.
• Serve as primary medical product customer quality assurance contact for external customers.
• Ensure quality and design requirements are executed on time.
• Lead root cause analysis and corrective action for quality issues.
• Develop and execute internal auditing processes for customer standards.
• Perform broader Quality Engineering functions including manufacturing support and training.
• Recommend and implement improvements to quality systems and processes.

Connaissances

Quality Engineering

Regulatory compliance

Root cause analysis

Cross-functional collaboration

Formation

BS Degree in Engineering/Engineering Technology

Description du poste

Abrasive Technology is seeking a Quality Assurance Engineer for Medical products in Lewis Center, OH. You will drive quality in the medical manufacturing environment, collaborate with engineering, manufacturing, and operations, and focus on regulatory compliance, continuous improvement, and product performance.

The role requires strong root cause analysis, auditing, and cross-functional teamwork to meet ISO and medical device standards while delivering high-quality medical components.