JOB SUMMARY:
The Principal Quality Engineer plays a critical lead and support role within product divisions of Medline. This position exists to ensure high-quality standards are met throughout the product development lifecycle and mass production processes.
Key responsibilities include:
1. Leveraging expertise in various plastic materials, including PP, PVC and others, to contribute to product design, tooling, and manufacturing techniques such as injection molding, extrusion, and blowing.
2. Managing projects effectively and utilizing process validation to drive plastic product development from concept through completion.
3. Conducting root cause analysis on significant issues that arise during development and production, and implementing corrective and preventive actions.
4. Exhibiting strong leadership and communication skills to influence cross-departmental collaboration, particularly with QA, PM, Sourcing, SQE, suppliers, and various teams across Asia.
Drawing on successful previous experience within a global organization to facilitate smooth project completion and provide valuable insights from a quality perspective.
JOB RESPONSIBILITIES:
1. Possess a deep understanding of the performance characteristics of plastic materials such as PP and PVC, and demonstrate expertise in plastic product design, tooling, injection molding, extrusion, and blow molding.
2. Facilitate regular communication and updates with suppliers to ensure they remain informed about the internal and International standards, processes, and procedures relevant to medical devices.
3. Take responsibility for project management and development, demonstrating experience in sample development, testing, process validation, and qualification.
4. Conduct root cause analyses on critical issues that arise during product development and mass production, and to identify and enact corrective and preventive actions accordingly.
5. Execute in-line and final product verifications in accordance with internal and International standards, ensuring that quality benchmarks are achieved.
6. Collaborate with cross-functional teams (Div QA and PM) to establish appropriate testing parameters, minimizing product failures.
7. Manage vendor-related projects from a quality perspective, focusing on product design changes, quality performance improvements, and monitoring critical processes.
8. Partner with suppliers and the corporate office in the U.S. to address and resolve key customer complaints. Analyze root causes at an expert level and implement Corrective and Preventive Actions (CAPAs) to decrease complaint rates.
9. Work closely with suppliers and the Quality Control (QC) team in China to reduce product rejections, prioritizing major issues.
10. Identify opportunities for improvement in products and processes with suppliers that lead to cost savings.
11. Collaborate with suppliers to validate and optimize production parameters, ensuring proper documentation and verification of these parameters once implemented.
12. Serve as a mentor to other quality colleagues in the plastic field, facilitating knowledge transfer and sharing best practices with the Asia quality team.
QUALIFICATIONS:
1. M.S. or B.S. Degree in Mechanical Engineering, Plastic Material, or Industrial engineering field is required.
2. 10+ years of engineering experience, with a preference for project management expertise.
3. Experience in process control and quality control is required.
4. Expertise in plastic is essential.
5. Quality background on medical device is preferred.
6. Understanding of quality system requirements (ISO 13485 or ISO 9001)
7. Ability to read and interpret product specifications and drawings.
8. Detail-oriented with robust written and verbal communication, problem-solving, and organizational skills.
9. Demonstrates a professional attitude and a heightened sense of urgency to complete tasks accurately and efficiently.
10. Capable of recognizing and suggesting improvements for finished products, processes, and documentation practices to suppliers, managers, and colleagues.
11. Strong leadership skills, coupled with outstanding communication and influencing abilities.
12. Successful experience within a global organization is required.
13. Proficient in PC applications, including AutoCAD or SolidWorks, MS Word, MS Excel, Adobe, and E-mail.
14. Skilled in quality tools such as APQP, P-MAP, FMEA, Control plan, MSA, PPAP.
15. Willingness to travel up to 50%.
16. Excellent English language skills in speaking, reading, and writing.
17. Ability to manage special projects as directed by manager.