Validation Engineer - Sterling Engineering, Inc.
Buffalo Grove, IL 60089
About the Job
Overview:
As a Quality Validation Engineer, you'll play a pivotal role in ensuring the highest quality standards in the manufacturing of medical devices. Join a world-renowned company at the forefront of drug delivery solutions, and be part of a team that is revolutionizing the pharmaceutical and biotechnology industries.
Job Responsibilities:
As a Quality Validation Engineer, you'll play a pivotal role in ensuring the highest quality standards in the manufacturing of medical devices. Join a world-renowned company at the forefront of drug delivery solutions, and be part of a team that is revolutionizing the pharmaceutical and biotechnology industries.
Job Responsibilities:
- Spearhead the planning, coordination, and execution of validation projects, ensuring seamless development and production of products that meet customer and internal quality objectives.
- Collaborate with cross-functional teams to investigate and resolve customer complaints, leveraging your problem-solving skills and industry expertise.
- Evaluate and manage supplier performance, fostering strong partnerships and ensuring mutual understanding of specified requirements.
- Coordinate and lead the execution of validations, change control activities, and the creation of comprehensive written protocols.
- Conduct supplier quality evaluations, audits, and implement quality agreements to maintain compliance and foster continuous improvement.
- Analyze statistical data and develop product specifications, ensuring accuracy and adherence to industry standards.
- Promote and organize training activities for internal departments, fostering a culture of quality and continuous learning.
- Collaborate with customers to ensure mutual understanding of requirements and objectives, ensuring their satisfaction.
- Support and maintain compliance with ISO and FDA QSR quality systems, as well as company policies and initiatives.
- Identify and execute continuous improvement projects, leveraging Six Sigma tools and methodologies.
Requirements:
- Bachelor's degree in Engineering, Science, or a related field.
- 3+ years of experience in a Quality position, preferably in the Medical Device industry (ISO 13485).
- Proven expertise in technical writing, IQ/OQ/PQ, and equipment validation.
- Excellent communication skills, with the ability to understand, read, write, and speak English fluently.
- Proficiency in advanced mathematical concepts and intermediate statistical (SPC) knowledge.
- Six Sigma experience, training, or certification is preferred. SAP experience is an added advantage.
- Ability to travel up to 25% domestically and internationally.
Salary: $95,000-$115,000
Source : Sterling Engineering, Inc.
