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Senior Quality Assurance Engineer
2 months ago
As a Principal Quality Assurance Engineer at Abbott Laboratories, you will play a critical role in ensuring the quality and compliance of our medical devices and diagnostic solutions. This position requires a strong background in quality assurance, regulatory compliance, and project management.
Key Responsibilities- Develop and maintain quality engineering methodologies and provide quality engineering support within several areas of the Quality System, including Operations, Data Analytics, and Continuous Improvement.
- Represent the voice of Quality to lead and execute complex projects that drive continuous improvement, and ensure compliance with regulatory, customer, and internal requirements.
- Lead, coach, and mentor junior engineers, and provide oversight to one or more QA professionals and/or contractors.
- Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization.
- Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Bachelor's Degree in a relevant field, such as Engineering, Quality Assurance, or a related field.
- Minimum 5 years of experience in Quality Assurance and/or Manufacturing and/or Engineering, with 5-7 years of relevant experience preferred.
- Basic HACCP Certification, Preventive Controls Qualified Individual (PCQI) Certified, and Safe Quality Food (SQF) Practitioner preferred.
- Industry certification or advanced degree preferred.
- Minimum 8 years in Class III or II medical device experience, with roles of increasing responsibility, impact, and scope within a manufacturing support environment in quality desired.
- A competitive salary range of $95,000.00 – $190,000.00, depending on location.
- A comprehensive benefits package, including medical, dental, and vision coverage, as well as a 401(k) plan and tuition reimbursement.
- Opportunities for professional growth and development, including training and education programs.
- A dynamic and collaborative work environment, with a team of experienced professionals who are passionate about quality and compliance.
