Job Description
Job Description
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 :
- 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
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As a Quality Validation Engineer, you'll play a pivotal role in ensuring the highest quality standards in the manufacturing of medical devices. Spearhead the planning, coordination, and execution of validation projects, ensuring seamless development and production of products that meet customer ...
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