Quality Control Manager

About the role

You will manage the quality function by providing work direction for quality engineers and inspectors and interact regularly with engineering, manufacturing, and service functions to establish quality standards for raw materials, work in process, and finished products.

Responsibilities

• This position operates on an on-site / hybrid work schedule (role-dependent).
• Formulate a strategy to foster a high-performance culture with quality right first time suitable for a world-class medical device contract and legal manufacturer.
• Coach and develop staff who support the quality function during the manufacturing process and drive a culture of quality awareness.
• Drive improvements to the quality system that ensures its suitability, adequacy, and effectiveness.
• Understand and ensure compliance with cGMP, ISO 13485, and FDA 21 CFR Part 820 regulations.
• Work closely with commercial and operations to build value with top 10 key accounts and engage with customer quality representatives directly to implement short, medium, and long-term innovation and improvement plans.
• Required:
• Bachelor's degree in Engineering or a scientific related field.
• A minimum of 4 years of experience in the medical device or pharmaceutical industry with at least 3 years of experience in regulatory compliance and quality systems.
• At least 4 years of experience in managing a team.
• Skills you need to succeed:
• Thorough knowledge of ISO 13485 and 21CFR Part 820.
• Strong written and verbal communication skills alongside strong presentation skills, with the ability to effectively work with various functions and levels within the organization.

Benefits

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Company Intel

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