Lubrizol Plant Quality Manager in Corona, California
Plant Quality Manager
Req ID: 48218
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.
JOB TITLE: Plant Quality Manager DATE: December 7, 2018
REPORTS TO: Plant Manager DEPARTMENT: Quality
CLASSIFICATION: Exempt DIRECT REPORT(S): Yes
WORK LOCATION: Corona, CA REVISED: 01/17/2019
The primary responsibility of the Plant Quality Manager is to lead all aspects of the company’s Quality System, including but not limited to Customer requirements, applicable industry standards, GMP’s, applicable regulatory requirements, quality assurance and quality control of manufacturing processes and product realization. Responsible for managing Customer complaints, CAPA system and Non-conforming materials, Audit program, Risk management process and Supplier management program. Direct responsibility over Quality Control and Document Control departments. Key element of Validation program and Continuous Process Improvement program. Directly responsible for implementing and maintaining systems that ensure compliance with applicable ISO standards and 21 CFR Part 20. This position also serves as the Management Representative.
DESCRIPTION OF ESSENTIAL DUTIES:
Lead all aspects of the Quality System
Define quality control strategies
Interaction with Customers regarding quality agreements, inspection plans, inspection methods, acceptance criteria, change management and deviations
Oversee the preparation of internal and external Validation protocols and reports
Develop, track, analyze and report Quality data related to product and key processes such as supplier performance, audit results, etc. to demonstrate the effectiveness of the company’s Quality System and to identify trends
Establish and conduct Management Reviews
Plan and execution of training and development of staff
Manage Suppliers and report on performance
Manage internal and external audits
Manage second or third-party testing to ensure facility systems compliance including test equipment, cleanroom, and other facility systems such as compressed air system, etc.
Manage records for product traceability.
HIRING GUIDELINES : To perform job successfully, and individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required/preferred.
Understanding of ISO requirements 13485:2016, ISO 14644:2015, 14971:2012 and FDA regulatory requirements
“Hands-On” type of person requiring minimal direction
Able to work in a fast paced, and high stress environment
Able to multitask and manage multiple projects concurrently
Able to manage and supervise others
Highly organized and neat
Excellent computer skills (MSOffice, MSProject, FileMaker Pro, Internet and E-mail)
Excellent communication skills able to comfortably present thoughts and ideas to senior management
Demonstrated success in developing or upgrading a quality management system
Perform other duties, as required
- Bachelor’s degree, preferably in engineering or other scientific background
15 years of related experience in cGMP/FDA regulated industry
Minimum of 10 years of experience managing Quality Assurance or regulatory compliance in the Medical Device industry
Potential Safety Hazards and Special Requirements:
Cuts and burns
Spill and trip hazards. Falls from ladders or step stools
Prolonged computer use
Able to lift up to 50 lbs.
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.
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.
Nearest Major Market: Corona
Nearest Secondary Market: Los Angeles
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