Quality Engineer
Lubrizol s contract manufacturing business 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 Lubrizol family.
The Medical Device Contract Manufacturing business is located in Corona, California, which is located in Riverside County.
We less than 30 miles away from the beach and Disneyland.
JOB DESCRIPTION
JOB TITLE:
Quality Engineer
DATE:
July 2020
REPORTS TO:
Quality Assurance Manager
DEPARTMENT:
Quality Assurance
CLASSIFICATION:
Exempt
DIRECT REPORT(S):
No
WORK LOCATION:
Corona, CA
REVISED:
July 2020
POSITION
Summary:
The purpose of this job is to provide support to the development of new manufacturing and quality processes.
The Quality Engineer provides engineering support of the Company s Quality Systems, ensuring compliance to ISO 13485, CFR Title 21 Part 820, ISO 14971 and other applicable standards.
The Quality Engineer provides product engineering support by assessing risk, process capabilities, developing and implementing effective quality assurance controls.
The Quality Engineer must have a hands-on approach to problem solving, problem investigation and data mining.
DUTIES AND
Responsibilities:
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.
Apply 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) Conduct risk analysis, create or revise Control Plans for new and existing products Complete projects in a manner consistent with corporate objectives.
Provide support in the rapid resolution of product complaints and/or safety issues.
Provide quality assurance appraisal of suppliers.
Conduct quality process and product audits and develop responsive corrective action plans.
Technical writing to document current practices to meet quality requirements necessary for QMS.
Support completion of Customer requests (e.
g.
, Supplier surveys, EU MDR compliance Declarations, etc.
) 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.
EXPERIENCE REQUIREMENTS AND TRAINING GUIDELINES:
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 capability 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, JMP or Statgraphics.
Familiarity with test methods validations or measurement systems analysis, test and inspection equipment, and valid acceptance sampling plans.
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.
KNOWLEDGE:
Understanding of ISO 13485, FDA 21CFR Part 820, cGMP is required.
Working knowledge of EU regulations (e.
g.
, MDR, REACH, RoHS.
) Solid understanding of the fundamentals of statistics.
Familiarity with SPC.
Effective problem solving and root-cause analytical skills.
Project planning and management skills.
EDUCATION:
Bachelor s Degree in an engineering or technical discipline with (2) years minimum experience in manufacturing, engineering, or quality.
COMPUTER SOFTWARE:
Proficiency in Microsoft Office.
CERTIFICATION AND/OR LICENSES:
CQE Certification a plus
The above statements reflect the general details necessary to describe the principle functions of the occupation described and shall not be construed as a detailed description of all the work requirements that may be inherent in the occupation.
The 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.
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.
Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
