Quality Engineer

Lab Medical Manufacturing; Summerville (SC); Presencial; USD 70.000 - 100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical insurance

Dental insurance

Paid time off

LTD

STD

Life insurance

401K with match

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Quality systems knowledge

Educación

BS in Mechanical/Manufacturing/Biomedical Engineering

ISO 13485 Internal Auditor training

Herramientas

Minitab

Microsoft Office

Descripción del empleo

ISO 13485 registered manufacturer of medical devices has opening for:

Quality Engineer

Lab Medical Manufacturing Inc. is an ISO 13485 registered company and has been manufacturing machined and finished assembly products for the medical industry for over 30 years.

Summary of Position:

Lab Medical Manufacturing Inc. is seeking a Quality Engineer. The candidate will support new product development as well as sustaining existing products. The candidate will be responsible to:

• Monitor, identify, and report on non-conformances as well as corrective actions and process improvements implemented to eliminate recurrence.
• Act as chairperson of the MRB process
• Provide guidance and/or training for manufacturing and quality control personnel to enhance Quality Assurance, 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.

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.

Lab Medical Manufacturing Inc. offers a team-oriented and excellent work environment. Our employees enjoy competitive wages, and a comprehensive benefit package including medical, dental, paid time off, LTD, STD, Life insurance and 401K with match.