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Date: Jan 20, 2018

Location: Corona, California, US, 92879

Company: Lubrizol Corporation

Req ID: 27282 

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.

Image result for lubrizol lifesciences

 

The role of the Quality Engineer will provide support to the development of new manufacturing and quality processes. This person provides engineering support of the Company’s Quality Systems, ensuring compliance to ISO 13485, CFR Title 21 Part 820 and other applicable standards. Additionally, this person provides product engineering support by assessing risk, process capabilities, developing and implementing effective quality assurance controls. Must have a “hands-on” approach to problem solving, problem investigation and data mining.

 

WHAT YOU WILL DO:

  • Develop, write, and assist with the implementation of effective quality assurance controls
  • Write validation and verification plans and protocols, assist with IQ/OQ/PQ activities, including finalize reports.
  • Coordinate the identification, assignment, monitoring, and completion of process and/or product improvement projects.
  • Work with the operations and engineering functions to coordinate pilot production of new products
  • Coordinate the reporting, analysis, and resolution of material nonconformance occurrences.
  • Capable of applying statistical and quality tools to analyze data and perform thorough Root Cause Analysis, execute CAPA processes and improve process capabilities (5S, Lean, 6 sigma, DOE, SPC)
  • Complete projects in a manner consistent with corporate objectives.
  • Provide support in the rapid resolution of product complaints and/or safety issues.
  • Develop and conduct training programs regarding company quality systems.
  • Provide quality assurance appraisal of suppliers.
  • Conduct quality process and product audits and develop responsive corrective action plans.
  • Technical writing ability to document current practices to meet quality requirements necessary for QMS.
  • Familiarity with test methods validations or measurement systems analysis, test and inspection equipment, and valid acceptance sampling plans.
  • As directed, provide specific support for operational quality management system programs.
  • Perform other required duties as needed in addition to the essential duties and responsibilities described above.

 

WHAT YOU NEED:

  • Experience in medical device industry.
  • Experience and familiarity with tools of root cause analysis and defect analysis, including failure mode and Effect Analysis (FMEA).
  • Experience with 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 capabilities assessments. Able to develop and establish Control Plans, FMEAs, PPAPs.
  • Experience with SPC. Able to apply statistical methods, and analysis utilizing statistical software such as Minitab or JMP.
  • Experience with quality management systems.
  • Experience with Lean, or Six Sigma manufacturing principles.
  • Ability to perform cost estimating based on labor, material and variable overhead inputs.
  • Able to lead and influence others to drive change.
  • Strong written and verbal communication skills.

 

KNOWLEDGE & EXPERTISE NEEDED:

  • Understanding of ISO 13485 21CFR Part 820, cGMP is preferred.
  • Solid Understanding of the fundamentals of statistics. Familiarity with SPC.
  • Project planning and management skills.
  • Effective problem solving and root-cause analytical skills.

 

EDUCATION:

  • Bachelor’s Degree in an engineering or technical discipline with (2) years minimum experience in manufacturing, engineering, or quality
  • Alternatively, a non-technical degree with (5) years of experience in manufacturing, engineering, or quality assurance experience

 

 

 

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 race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.


Nearest Major Market: Corona
Nearest Secondary Market: Los Angeles

Job Segment: Quality Engineer, Manufacturing Engineer, Engineer, CAPA, Engineering, Quality, Management