Quality Engineer – Medical Devices (ISO 13485)

LAB Medical Manufacturing, Inc; Summerville (SC); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Paid time off

LTD

STD

Life insurance

401K with match

Job summary

Lab Medical Manufacturing Inc. is an ISO 13485 registered manufacturer of medical devices with over 30 years of experience. The company seeks a Quality Engineer to support new product development and sustaining existing products.

The role includes leading MRB, CAPA, PPAP-related risk activities, and customer liaison for complaints, with opportunities to train staff and improve QA processes. Competitive benefits are offered.

Qualifications

• Bachelor of Science in Mechanical, Manufacturing, or Biomedical Engineering.
• 3-5 years of medical device manufacturing experience.
• ISO 13485:2016 Internal Auditor training is a plus.
• Proficiency in Minitab data analysis software.
• Proficiency in Microsoft Office suite.

Responsibilities

• Monitor, identify, and report on non-conformances and corrective actions to prevent recurrence.
• Act as chairperson of the MRB process.
• Provide guidance and/or training for manufacturing and quality control personnel to enhance QA, process control and improvement.
• Manage the customer complaint and RMA processes.
• Be the primary liaison with customers regarding risk management activities (PPAP programs, PFMEA’s, Control Plans, etc.).
• Perform and/or assist in Gage R&R and validation activities such as IQ/OQ/PQ.
• Work with engineering on the development of new processes.
• Document and implement Engineering Change Orders as required.
• Device History Record and Inspection creation and maintenance.
• Conduct and document internal audits per ISO13485:2016.
• Manage CAPA process for both external and internal non-conformances.

Skills

Quality systems knowledge

Education

BS in Mechanical/Manufacturing/Biomedical Engineering

ISO 13485 Internal Auditor training

Tools

Minitab

Microsoft Office

Job description

Lab Medical Manufacturing Inc. is an ISO 13485 registered manufacturer of medical devices with over 30 years of experience. The company seeks a Quality Engineer to support new product development and sustaining existing products.

The role includes leading MRB, CAPA, PPAP-related risk activities, and customer liaison for complaints, with opportunities to train staff and improve QA processes. Competitive benefits are offered.