Quality Engineer - Medical Devices | ISO/QMS Compliance

Keystone Manufacturing Llc; Kalamazoo (MI); Presencial; USD 70.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, vision

Life insurance

Disability insurance

Retirement plan with company match

Paid time off and holidays

Descripción de la vacante

Keystone Manufacturing Llc in Kalamazoo, MI is seeking a Quality Engineer to develop, maintain and improve quality standards for medical device manufacturing. The role involves root cause analysis, investigations into external complaints and internal non-conformances, and driving continuous QMS improvements.

Candidates should have a Bachelor’s in Engineering and at least two years in a regulated environment, with ISO 13485/QSR/GMP experience and proficiency in measurement tools.

Formación

• Bachelor's in Engineering required.
• Minimum 2 years in a regulated manufacturing environment.
• Experience with ISO 13485, QSR, GMP.
• Familiarity with measurement equipment (calipers, rulers, micrometers).
• Authorized to work in the US without sponsorship.

Responsabilidades

• Supports development of new product lines with quality considerations.
• Supports operations of critical quality issues to ensure effective manufacture of medical devices.
• Identify and communicate system improvements to meet target timeframes from compliance and business perspectives.
• Participates in external compliance audits – FDA, ISO, etc.
• Conduct and/or support training on QSR and ISO topics.
• Contributes to root cause analysis for NCRs, complaints and CARs.
• Conducts internal audits per Keystone Manufacturing QMS requirements.
• Work with production to resolve customer/product issues as needed.
• Reviews and approves SOPs ensuring alignment with requirements.
• In-house expert for EO sterilization and label creation.
• Maintain relationships with Production, Quality, regulatory affairs.
• Product assembly and production processing in times of need.
• Follow quality systems procedures as required.
• Prepare and ship samples to customers as requested by sales.

Conocimientos

Quality engineering

Regulated manufacturing

Root cause analysis

Documentation

Educación

Bachelor's Degree in Engineering

Herramientas

Calipers

Micrometers

Rulers

Inspection equipment

Descripción del empleo

Keystone Manufacturing Llc in Kalamazoo, MI is seeking a Quality Engineer to develop, maintain and improve quality standards for medical device manufacturing. The role involves root cause analysis, investigations into external complaints and internal non-conformances, and driving continuous QMS improvements.

Candidates should have a Bachelor’s in Engineering and at least two years in a regulated environment, with ISO 13485/QSR/GMP experience and proficiency in measurement tools.