Medical Devices Quality Assurance Specialist

At MediLink Solutions, we value diversity and are committed to creating an inclusive work environment. We offer a competitive salary and benefits package, and opportunities for career growth and development. If you are passionate about quality and have a strong background in medical device quality assurance, we would love to hear from you.

Position: Medical Devices Quality Assurance Specialist

Location: Arizona, United States

Company: MediLink Solutions

Industry: Medical Devices

Job Type: Full-time

Experience: 5-8 years

Salary: DOE

About the Company: MediLink Solutions is a leading medical device company that is dedicated to improving the quality of life for patients by providing innovative and reliable medical devices. We are committed to upholding the highest standards of quality and safety in all our products, and we are looking for a highly skilled Medical Devices Quality Assurance Specialist to join our team.

Job Description: As a Medical Devices Quality Assurance Specialist, you will play a critical role in ensuring the quality and safety of our medical devices. You will be responsible for developing and implementing quality assurance processes and procedures to ensure compliance with regulatory requirements and industry standards.

Key Responsibilities:

• Develop and maintain quality assurance policies and procedures for all stages of the medical device lifecycle, including design, development, manufacturing, and post-market surveillance.
• Conduct risk assessments and identify potential quality issues during the design and development phase of medical devices.
• Ensure compliance with all applicable regulatory requirements, including FDA regulations, ISO standards, and other relevant standards.
• Perform internal audits to assess compliance with quality management systems and identify areas for improvement.
• Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure the quality and safety of our products.
• Investigate and resolve customer complaints related to product quality, and implement corrective and preventive actions as needed.
• Conduct supplier audits to ensure that our suppliers meet our quality standards and regulatory requirements.
• Provide training and support to employees on quality assurance processes and procedures.
• Stay updated on industry changes and trends related to medical device quality assurance and make recommendations for process improvements.

Qualifications:

• Bachelor's degree in engineering, life sciences, or a related field.
• Minimum of 3-5 years of experience in quality assurance within the medical device industry.
• In-depth knowledge of FDA regulations, ISO standards, and other relevant quality standards.
• Strong understanding of risk management principles and techniques.
• Experience with quality management systems, such as ISO 13485.
• Excellent problem-solving and analytical skills.
• Strong attention to detail and ability to work in a fast-paced environment.
• Excellent communication and interpersonal skills.
• Ability to work independently and collaboratively in a team.
• Certification in quality assurance or regulatory affairs is a plus.

Apply now and join our team of dedicated professionals in making a positive impact on patients' lives.