BioTalent is partnered with a component manufacturer focusing on regulated industries to support in-house manufacturing. This individual will lead (and grow) an onsite team as our client expands their portfolio.

Responsibilities

• Develop, implement, and maintain a robust QMS in compliance with industry standards (ISO 9001, ISO 13485).
• Ensure all quality processes, procedures, and documentation are up to date and adhered to by all employees.
• Oversee the inspection of incoming materials, in-process production, and final products to ensure compliance with specifications and quality standards.
• Develop and implement inspection protocols, sampling procedures, and testing methods.
• Conduct root cause analysis and corrective actions for any non-conforming products or processes.

Qualifications

• Bachelor’s degree in Engineering, Manufacturing, Quality Management, or a related field.
• Minimum of 4 years of experience in a quality management role within a manufacturing environment, preferably in a component manufacturing industry.
• In-depth knowledge of quality management systems in accordance with ISO 13485 and ISO 9001, and regulatory requirements.
• Proficiency in quality improvement tools and techniques such as Six Sigma, lean manufacturing, root cause analysis, and statistical process control (SPC).