Quality Validation Engineer
Job Description
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.
- 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.
Meet Your Recruiter
Ric Delgado
Lead Technical Recruiter
Ric Delgado is a seasoned Principal Recruiter primarily focusing on the Automation Division at Sterling. With a distinguished tenure of over five years at Sterling and an impressive career spanning more than a decade in the recruiting field, Ric is a respected and accomplished professional in talent acquisition.
As a Principal Recruiter, Ric draws upon his extensive experience to excel in the Automation Division. His in-depth understanding of this dynamic industry enables him to connect talented individuals with exciting and fulfilling job opportunities expertly. Ric plays a pivotal role in helping candidates find new positions, advance in their careers, and achieve their professional goals.
Ric's passion for positively impacting individuals' lives through career advancement is the driving force behind his dedication to recruitment. He takes immense pride in his role as a professional growth and development facilitator, understanding the pivotal role a career change can play in a person's life journey.
He firmly believes in continuously updating one's skills and knowledge to stay competitive in any field. His commitment to personal and professional development not only enhances his own expertise but also positions him as a valuable resource for candidates seeking guidance in their career journeys.