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Senior Quality Engineer

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Date: Sep 23, 2022

Location: Corona, CA, US, 92879

Company: Lubrizol Corporation

Req ID: 81461 

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 Senior Quality Engineer, you’ll provide support to our quality system for the design, development, and manufacturing of finished medical devices. The Senior Quality Engineer provides engineering support for the Company’s quality systems, ensuring compliance to ISO 13485, CFR Title 21 Part 820 and design control standards. You’ll also provide product engineering support by assessing risk and process capabilities, along with developing and implementing effective quality assurance controls. You will use a “hands-on” approach to continuous improvement of the quality system and implementation and Quality Assurance management of design control process, problem solving, problem investigation and data mining.

 

Essential Duties & Responsibilities

  • Develops, writes, and assists with the implementation of effective quality assurance controls
  • Writes and reviews validation and verification plans and protocols; assists with IQ/OQ/PQ activities, including finalize reports.
  • Compiles and reviews Design History Files and Master Device Records.
  • 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, executes CAPA processes, and improves process capabilities (5S, Lean, 6 Sigma, DOE, SPC).
  • Completes projects in a manner consistent with corporate objectives.
  • Provides support in the rapid resolution of product complaints and/or safety issues.
  • Develops and conducts training programs regarding company quality systems.
  • Provides quality assurance appraisal of suppliers.
  • Performs cost estimating based on labor, material, and variable overhead inputs.
  • Conducts quality process and product audits and develops responsive corrective action plans.
  • Uses technical writing ability to document current practices to meet quality requirements necessary for QMS for medical devices.
  • Provides specific support for operational quality management system programs.
  • Perform other duties as assigned.

 

Required Education, Skills & Experience

  • Minimum of a Bachelor’s degree in an Engineering or other Technical discipline (Engineering or Technical)
  • At least 5 years’ experience in the medical device industry.
  • Experience and familiarity with tools of root cause analysis and defect analysis, including Failure Mode and Effect Analysis for process and product design.
  • Experience with developing and implementing process controls, corrective and preventive action, and product and process quality improvement.
  • Experience with Design of Experiments.
  • Experience with Design History Files, Risk Management and Design output documentation.
  • Experience with Verification and Validation activities. Ability to conduct process analysis, and capabilities assessments. Able to develop and establish control plans, process and product design pFMEAs, PPAPs.
  • Understanding of ISO 13485 21CFR Part 820, cGMP and proficiency with Design Control requirements.
  • Solid understanding of the fundamentals of statistics and familiarity with SPC.
  • Experience with quality management systems.
  • Experience with Lean or Six Sigma manufacturing principles.
  • Able to lead and influence others to drive change.
  • Strong written and verbal communication skills.
  • Project planning and management skills.

 

 

Lubrizol offers competitive benefits: Medical, Dental, Vision, 401(k), Age-Weighted Defined Contribution Planand so much more!

Visit http://benefits.lubrizol.com to learn more.

 

 

#LI-JW1

 

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.

 

Do You Need Assistance?

Please let us know if you need an accommodation to proceed with your application for a posted job, or with any other aspect of the interview or assessment process.  You can either call 440-943-4200 and ask for Talent Acquisition or send an email to talentacquisition@lubrizol.com. Please note that this phone line and email address are not to be used for checking on the status of an already submitted application and not to be used by third party recruiters.


Nearest Major Market: Corona
Nearest Secondary Market: Los Angeles

Job Segment: Senior Quality Engineer, Lean Six Sigma, Quality Engineer, Medical Device Engineer, Six Sigma, Engineering, Management