Senior Quality Engineer - ISO Compliance

Join the forefront of medical device quality assurance as a Senior Quality Engineer specializing in ISO 13485 compliance. Collaborate with diverse teams to drive quality improvements and customer satisfaction.

In this influential role, you will ensure that all product development and manufacturing processes align with ISO standards. With a focus on leadership and collaboration, you will implement quality control plans and conduct thorough audits to identify areas of enhancement. Your analytical skills will be crucial in resolving issues and ensuring regulatory compliance.

Key Responsibilities:

• Support medical device development per ISO 13485

• Collaborate with Program Managers and Engineers

• Perform internal and supplier audits for compliance

• Utilize SPC systems to monitor quality metrics

• Investigate complaints and lead corrective actions

Requirements:

• 5-7 years in quality engineering

• Minimum two years in a leadership role

• Mastery of statistical tools and quality methodologies

• Strong knowledge of FDA regulations and ISO standards

• Excellent reporting and communication skills

Your quality engineering expertise will play a vital role in maintaining high standards in medical device product realization and quality assurance.
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