Quality Assurance Analyst ofertas em United States

TEC Partners is pleased to have partnered with a leader of innovation, development, and manufacturing solutions to the pharmaceutical and medical device industries. As one of the largest suppliers in the Life Science arena on a global scale, my client works closely with customers to provide highly engineered products that help millions live healthier lives!

• Provide direction and leadership to the Quality teams including people management.
• Maintain and improve quality systems to support the Strategic Plan for new business opportunities.
• Ensure compliance with medical device and pharmaceutical regulations and quality system requirements.
• Work with the Commercial team to represent Quality System with customers and potential customers.
• Work with management on risk assessment and regulatory compliance.
• Provide expertise for the continuous improvement of the quality system as it pertains to combination products.

• B.S. degree in quality, business, or engineering field.
• Ten years or more experience in a quality role within medical devices.
• Five years or more experience in a management role.
• Knowledge of FDA and international regulations and ISO standards related to medical device design and manufacturing (e.g., MDR, 21 CFR 11).
• Direct experience with audits and pre-approval inspections by regulatory authorities.

If you are passionate about quality, compliance, and driving excellence in the medical device sector, please apply with an up-to-date CV.