Manufacturing Quality Engineer

Manufacturing Quality Engineer

The Manufacturing Quality Engineer is responsible for designing, implementing, and monitoring quality control programs. Key responsibilities include recommending improvements to methods, procedures, and standards to enhance output quality based on data analysis. This role ensures products meet specifications, quality standards, and regulatory compliance while tracking and resolving defects.

Key Responsibilities:

• Design, implement, and maintain quality assurance protocols and methods for processing materials into partially finished or finished products for the supply chain.
• Plan, implement, and manage compliance of in-house and outsourced manufacturing processes with internal and external quality and regulatory standards for global distribution.
• Review inspection methods, testing procedures, and evaluation techniques to ensure precision and accuracy in production processes, equipment, components, and finished products.
• Analyze production reports and data trends to recommend updates or changes to quality standards and procedures.
• Ensure compliance with internal and external specifications and standards such as ISO 13485, MP, and MDSAP.
• Lead and facilitate investigations with cross-functional teams to identify root causes and implement corrective actions for product and component issues within the supply chain.
• Provide expertise in specialized quality assurance areas, requiring knowledge of key principles and concepts.

Additional Responsibilities: Depending on experience level, responsibilities may include:

• Performing routine quality assurance tasks (early career).
• Contributing to projects and process improvements (mid-career).
• Providing specialist guidance and expertise in primary focus areas.
• Leveraging professional experience to drive strategy and business results.
• Build and maintain productive internal/external working relationships.
• Occasionally lead project teams and provide training for junior staff.

Basic Qualifications and Experience:

• Bachelor's degree in a relevant field.
• Minimum 2 years of experience in manufacturing quality assurance.
• Experience applying company policies and procedures to resolve quality-related issues.
• Strong working knowledge of ISO 13485 and regulatory compliance for medical devices.

Must-Have Requirements:

• Bachelor's degree.
• Minimum 2 years of related experience.
• Strong knowledge of ISO 13485.
• Ability to apply professional expertise to resolve quality issues.

Additional Information:

• The team is preparing for an ISO Audit in October and requires expertise in ISO 13485 compliance.
• The Hiring Manager prefers candidates with realistic experience claims, avoiding exaggerated achievements (e.g., overstating QMS development).
• Candidates from CSUN's master's program in manufacturing (with a Green Belt certificate) have previously excelled in this role.
• The position is on-site at Chatsworth, CA, transitioning to Los Angeles, CA by September/October.
• Candidates must be willing to work on-site, five days per week at both locations.

Interview Process:

1. First Round: Virtual interview (Microsoft Teams) with the Hiring Manager.
2. Second Round: On-site interview with the Hiring Manager, including a facility tour.