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Quality Assurance Engineer for Suppliers
2 months ago
About Abbott
Abbott stands as a leading entity in global healthcare, dedicated to enhancing the quality of life across various stages. Our extensive range of transformative technologies encompasses diagnostics, medical devices, nutritionals, and branded generic medicines, supported by a workforce of 114,000 professionals operating in over 160 countries.
Why Work at Abbott?
At Abbott, you will engage in meaningful work, fostering personal and professional growth while maintaining a healthy work-life balance. We offer:
- Career advancement opportunities within a global organization.
- Comprehensive medical coverage for employees through the Health Investment Plan (HIP) PPO.
- A robust retirement savings plan with significant employer contributions.
- Tuition reimbursement and programs designed to assist with student debt and further education.
- A workplace recognized for its commitment to diversity and inclusion, earning accolades as a top employer in various categories.
The Role
The position of Quality Assurance Engineer for Suppliers is integral to our Infectious Disease Developed Markets unit, focusing on ensuring that all materials, products, and services received meet established quality standards.
Key Responsibilities:
- Oversee the Supplier Quality Function, collaborating closely with Purchasing and New Product Development teams.
- Address internal and external supplier inquiries related to quality in a professional manner.
- Manage supplier modifications through the change management system.
- Evaluate Supplier Validation Protocols to ensure compliance with regulatory and customer standards.
- Coordinate with engineering teams to schedule and conduct inspections and capability studies for purchased products.
- Conduct root cause analysis for product quality issues and implement corrective actions as necessary.
- Oversee the Supplier corrective action process and enhance the Approved Supplier List (ASL).
- Utilize supplier performance metrics to identify improvement opportunities and collaborate with suppliers to achieve quality objectives.
- Establish priorities to meet expectations effectively.
- Identify and implement continuous improvement initiatives to optimize quality systems and processes.
- Conduct external audits as needed based on established schedules or supplier performance issues.
Qualifications:
- Bachelor's degree in Engineering, Manufacturing, Biology, or a related field, or equivalent experience.
- Minimum of 2 years of experience in the medical device sector, preferably in Quality or Supplier Engineering.
- Proficient in Microsoft Word, PowerPoint, and Excel.
- Strong attention to detail and accuracy.
- Excellent organizational skills with the ability to prioritize effectively.
- Exceptional documentation and technical writing capabilities.
- Strong verbal and written communication skills in English.
- Able to build and maintain effective working relationships with colleagues and external partners.
- Ability to adapt quickly to changing priorities and circumstances.
- Independent reasoning and minimal supervision required.
- Strong analytical skills to interpret data and make informed decisions.
- High proficiency in Microsoft Office Suite.
Preferred Qualifications:
- Familiarity with federal regulations such as QSRs, ISO 13485, CMDR, IVDD/IVDR.
- Knowledge of 21 CFR Part 11 regarding Electronic Records and Electronic Signatures.
Abbott is an equal opportunity employer, committed to fostering a diverse workforce and providing reasonable accommodations to qualified individuals with disabilities.
