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Senior Quality Assurance Engineer
2 months ago
We are seeking a highly skilled Senior Quality Assurance Engineer to join our team at Abbott Laboratories. As a key member of our Infectious Disease Developed Markets Business, you will be responsible for ensuring the quality of our supplied products and materials.
Key Responsibilities- Contribute to the development and maintenance of supplier quality engineering methodologies, systems, and practices that meet company and regulatory requirements.
- Review and approve all supplied product drawings and component quality plans.
- Manage the development of supplied product inspection procedures and first article requirements.
- Provide engineering guidance to division Receiving Inspection, including statistical analysis, measurement techniques, Gage R&R studies, and inspection procedures.
- Assess supplier capabilities through direct visits, technical discussions, directed testing, and quality system audits.
- Proactively communicate quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests, and technical discussions.
- Participate in and provide engineering ownership for all supplied product Nonconforming Material Reviews.
- Evaluate and develop Supplied Data Agreement partnerships with suppliers.
- Apply sound engineering analysis and judgment to reduce the need for inspection in accordance with program policies.
- Work with Manufacturing engineering to assess and address purchased product issues.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Design and conduct experiments for process optimization and/or improvement.
- Bachelor's degree in Engineering or Technical Field.
- Minimum 5 years of related experience.
- Engineering experience and demonstrated use of quality tools/methodologies.
- Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
- Solid communication and interpersonal skills.
- Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
- Advanced computer skills, including statistical/data analysis and report writing skills.
- Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
- Master's degree preferred.
- Prior medical device experience preferred.
- Demonstrated supervisory experience preferred.
- ASQ CQE or other certifications preferred.
- Experience working in a broader enterprise/cross-division business unit model preferred.
At Abbott Laboratories, you can do work that matters, grow, and learn, care for yourself and family, be your true self, and live a full life.
We offer a range of benefits, including:
- Career development with an international company where you can grow the career you dream of.
- Free medical coverage for employees* via the Health Investment Plan (HIP) PPO.
- Health care and well-being programs, including medical, dental, vision, wellness, and occupational health programs.
- Medical Benefits start day 1.
- Vacation – 3 weeks of accrued vacation (1st yr. is prorated) + vacation buy program + 3 personal days + 10 paid holidays.
- An excellent retirement savings plan with high employer contribution.
- Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit – an affordable and convenient path to getting a bachelor's degree.
