Job Summary:

Sincera Talent Partners is working with a leader in the medical device industry to hire a highly skilled Quality Assurance Engineer. In this role, you will ensure that all products meet the strict regulatory requirements for medical devices, including FDA and ISO standards. You will collaborate with cross-functional teams to improve quality processes, implement corrective actions, and ensure compliance throughout the product development lifecycle.

What We Offer:

• Competitive Salary: Compensation that recognizes your expertise in quality assurance.
• Comprehensive Benefits Package: Full medical, dental, and vision coverage for you and your dependents.
• Professional Development: Access to training programs to enhance your regulatory knowledge and career.
• PTO and Holidays: Paid time off and company holidays.
• Innovative Work Environment: Join a team that values innovation and quality in the development of life-saving medical technologies.

Key Responsibilities:

• Ensure compliance with FDA, ISO, and other regulatory standards for medical device production.
• Develop, implement, and maintain quality assurance processes, including CAPA (Corrective and Preventive Actions).
• Perform audits of internal and external processes to ensure compliance with regulatory requirements.
• Collaborate with R&D, manufacturing, and engineering teams to improve product quality and reliability.
• Lead root cause analysis investigations and implement corrective actions to resolve product defects.
• Prepare and present reports on quality metrics, audits, and non-conformance issues.

Minimum Requirements/Qualifications:

• Bachelor’s degree in Engineering, Quality Assurance, or a related field.
• 3-5 years of experience in quality assurance within the medical device industry.
• In-depth knowledge of FDA regulations, ISO 13485, and other relevant standards.
• Strong problem-solving skills and experience leading CAPA initiatives.
• Excellent communication and collaboration skills, with experience working in cross-functional teams.

Equal Employment Opportunity Statement:

Sincera Talent Partners promotes diversity in the workplace, recognizing the value that different perspectives bring to innovation. We only partner with companies that share our commitment to diversity, equity, and inclusion, ensuring equal opportunities for all employees.

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