|Date Posted||August 2, 2022|
Req ID: 81442
Vesta, a Lubrizol company is a contract manufacturer that specializes in producing thermoplastic extruded tubing and components for medical devices that are used in hospitals internationally. We strongly believe that it takes quality people to make quality products that are so important for everyday use, and we are always looking to expand our Vesta family. Vesta is located in Corona California which is located in Riverside County. We less than 30 miles away from the beach and Disneyland.
Vesta Corona, California location has a class 8 certified clean room, which is 17,000 square feet. We have 14 extrusion lines as well as co-ex lines. We are able to run multiple extruders which can produce a two layer, stripes and three layer extrusion.
As the Quality Engineer, you ll support to the manufacturing and quality processes for medical components. The Quality Engineer provides engineering support of our quality systems, ensuring compliance to ISO 13485, CFR Title 21 Part 820, ISO 14971 and other applicable standards. You will provide product engineering support by assessing risk and process capabilities and developing and implementing effective quality assurance controls. You will use a "hands-on" approach to problem solving, problem investigation and data mining.
Essential Duties & Responsibilities
- Develops, writes, and assists with the implementation of effective quality assurance controls
- Writes validation and verification plans and protocols; assists with IQ/OQ/PQ activities, including finalizing reports.
- Coordinates the identification, assignment, monitoring, and completion of process and/or product improvement projects.
- Partners with the operations and engineering functions to coordinate pilot production of new products.
- Coordinates the reporting, analysis, and resolution of material nonconformance occurrences.
- Applies statistical and quality tools to analyze data and perform thorough Root Cause Analysis (e.g., Fishbone Diagram, 6M, 5Whys), execute CAPA processes and improve process capabilities (e.g.,5S, Lean, 6 Sigma, DOE, SPC).
- Conducts risk analysis; creates or revises control plans for new and existing products.
- Completes projects in a manner consistent with corporate objectives.
- Provides support in the rapid resolution of product complaints and/or safety issues.
- Provides quality assurance appraisal of suppliers.
- Conducts quality process and product audits and develop responsive corrective action plans.
- Applies technical writing skills to document current practices to meet quality requirements necessary for QMS.
- Supports completion of customer requests (e.g., supplier surveys, EU MDR compliance declarations, etc.).
- Provides specific support for operational quality management system programs.
- Performs other duties as assigned.
Required Education, Skills & Experience
- Bachelor s Degree in an engineering or technical discipline
- At least 2 years experience in medical device industry.
- Understanding of ISO 13485, FDA 21CFR Part 820, cGMP and working knowledge of regulations (e.g., EUMDR, REACH, RoHS, etc.)
- Solid understanding of the fundamentals of statistics. Familiarity with SPC.
- Experience and familiarity with tools of root cause analysis and defect analysis, including Failure Mode and Effect Analysis (FMEA).
- Experience developing and implementing process controls, corrective and preventive action, and product quality improvement.
- Experience with DOE.
- Experience with verification and validation activities. Ability to conduct process analysis, and capability assessments. Able to develop and establish Control Plans, FMEAs, PPAPs.
- Familiarity with test methods validations or measurement systems analysis, test and inspection equipment, and valid acceptance sampling plans.
- Experience with quality management systems.
- Excellent written and verbal communication skills. Ability to lead and influence others to drive change.
- Excellent project management skills.
- Experience with Lean or Six Sigma manufacturing principles.
- CQE Certification a plus.
Lubrizol offers competitive benefits: Medical, Dental, Vision, 401(k), Age-Weighted Defined Contribution Plan and so much more!
Visit to learn more.
Vesta is located in Corona CA, the golden state. Corona is located in Southern California where the beaches are less than 30 miles away. You can take a 20 minute drive to the Happiest Place on Earth- Disneyland and see their beloved firework show at 9:00pm every night. Corona is a 45 minute drive to Los Angeles, the entertainment capital in the world. The City of Los Angeles is home of the new Los Angeles Rams who have shaken up and created new excitement for the locals. This city is diverse with many different cultures and restaurants. Summer starts off with many different music festivals such as: Coachella, Snowglobe, Stagecoach and so much more. Vegas is less than 4 hours away and an easy drive for a weekend getaway.
Lubrizol is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to sex, race, color, national origin, citizenship, age, religion, marital status, military service, sexual orientation, genetic information, gender identity, or any other characteristic or trait protected by federal, state, or local law.
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