Vesta, part of Lubrizol LifeSciences, offers custom medical manufacturing services, including precision thermoplastic and silicone extrusion as well as comprehensive silicone fabrication from its ISO 13485 certified facilities. Vesta capitalizes on more than 40 years’ experience, leveraging expertise in design assistance, material selection and quality compliance to enable our customer’s success.
Vesta has served as a trusted medical device outsourcing partner for four decades, delivering innovative solutions in molding, extrusion and assembly. Our Franklin, Wisconsin location includes ISO 7 certified clean room, ISO 8 controlled environment, 116,000 ft2 (10,700 m2), 17 extruders with 12 lines, 75 molding presses and a dedicated R&D laboratory. Every one of our medical device manufacturing, assembly and support services has quality at its core. Our highly collaborative, end-to-end, medical device process validation ensures quality without sacrificing product performance.
The Quality Systems Engineer is primarily responsible for assuring Quality Systems quality compliance through the development, implementation, improving and monitoring of appropriate processes to meet quality/business metrics and goals. Specifically, the Systems Engineer is the process owner for different quality systems (CAPA program, customer complaints, nonconformance, internal and external audits, risk management and so forth).
DESCRIPTION OF ESSENTIAL DUTIES:
Demonstrates critical thinking and problem-solving skills to address internal nonconformance, CAPA, customer complaints and continuous improvement project.
Ensures quality and business objectives are consistently met.
Facilitates cross-functional collaborations to drive projects to completion within the established timeline.
Benchmarks, improves and streamlines existing processes to achieve best-in-class status.
Acts as subject matter experts of responsible systems.
Leads continuous improvement activities (individual effort or cross-functional team).
Trends quality data and facilitates data review to detect potential issues.
Hosts and participates in internal and external audits.
Provides detailed and timely follow-up with customer facing activities.
Maintains current knowledge of ISO 13485 and FDA QSR requirements and applies to applicable Vesta processes.
Previous experience in medical device industry
Bachelor’s degree, preferably in a science or engineering-related discipline
Excellent written and verbal communication skills
Flexible to change with a high degree of integrity and “can do attitude”
Willing to work in a team environment and contribute to group goals
Ability to receive and provide feedback in a positive manner.
Computer skills, including Microsoft products
CONSIDERED A PLUS:
Knowledge of ISO 13485:2016, FDA 21 CFR Part 820
Experience with Statistical Process Control and Process Validation
Certified Quality Engineer or Auditor (ASQ)
Six Sigma Green or Black Belt
Strong technical writing skills applicable to the medical device industry or equivalent regulated industry
About The Lubrizol Corporation
The Lubrizol Corporation, a Berkshire Hathaway company, provides unmatched science that unlocks immense possibilities at the molecular level. Our solutions are found in products used by people every day, driving sustainable and measurable results to help the world Move Cleaner, Create Smarter and Live Better.