Job Information
Corning Incorporated Quality Engineer II - Onsite in Woodland, California
Quality Engineer II - Onsite
Bioengineering
Biotechnology
Change Control
Chemistry
Immunology
Inspections
ISO
ISO Standards
Medical Device
Peoplesoft
QMS
Root Cause Analysis
SAP
SIX Sigma
SOPS
Statistical Analysis
Virology
Description:
This job posting is for a contingent resource on assignment with Corning Incorporated. This position could provide you with an opportunity to help Corning push the boundaries of technology while enjoying the benefits of working for Magnit. Magnit is a leading, global professional services and technology company and a certified “Great Place to Work” Magnit has been a leader in contingent workforce management since 1991 and work with leading Fortune 500 companies and other large organizations across the world.
Job Title: Quality Engineer II
Scope of Position:
Develop and support all Quality Management System (QMS) / Regulatory Affairs (RA) activities and functions supporting the quality goals and quality metrics for site. Responsible for new product setup, quality project management, and regulatory compliance of serum products. Ensure compliance to in-house and/or external specifications and standards such as cGMPs, 21 CFR 820, ISO 13485, and Quality System Procedures.
Day to Day Responsibilities:
Ensure compliance to new and changing regulations affecting products and processes
including, but not limited to, QSR’s, global import/export regulations, etc.
New product setup and management of related projects
Assist with Supplier audits, as needed
Maintenance of BSE Serum Certificates of Suitability filing with EDQM
Collaborates with USDA on regulatory compliance activities including regulatory
approvals, import/export compliance, traceability, quarantine, safety testing and affidavits
Serve as a resource for customer’s regulatory and technical inquiries
Ongoing maintenance of ISO 13485 based quality system
Implement and handle CAPA (Corrective and Preventive Actions) and problem resolution
Coordinates and leads Quality Documentation, Nonconformance Reports, Inspection
Activities, and Product Disposition
Coordinates the review and revision of procedures, specifications, and forms to maintain and improve the QMS
Quality Help Desk and customer complaint point of contact and problem resolution including Questionnaires, Certificates and Customer Surveys, etc.
Perform Internal Audits in support of internal requirements, 21 CFR 820 and ISO 13485 compliance
Assists in representing in customer quality audits, supplier quality audits and regulatory inspections
Performs investigations and analysis activities to support resolution of quality issues
Collaborates with organizational teams to support quality system implementation
Creation of new product master files satisfying customer and quality system requirements
Ensures quality standards by following company & departmental policies & procedures including, but not limited to: Product performance & quality verification; Identifying, recording, and investigating problems related to and product, process & quality systems; Evaluating processes for improvements and standardization and Initiating action to prevent non-conformance in products, process, and quality systems
Training on quality systems and applicable regulations as identified by supervisor and required by position
Tracking/trending aspects of the QMS
Other job duties as required:
Travel Requirements: Less than 10%
Hours of work/work schedule/flextime: Standard business hours, Monday – Friday
Required Education: Minimum of Bachelor’s degree in Science, Engineering, Bioengineering or related field
Prefer Chemistry or Biology degree programs
Preferred Education, Years and Area of Experience: Minimum 3 years’ experience in Quality or Regulatory, preferably in a medical device, pharmaceutical or biotechnology environment/industry
Required Skills:
Thorough knowledge and practical application of Quality Systems Regulations 21 CFR 820 and ISO 13485
Ability to develop, update and train on SOPs
Working knowledge of ISO standards and Quality Management Systems (QMS)
Problem solving techniques to perform investigations and drive root cause analysis
Related work experience performing internal/external audits
Ability to monitor the QMS such as: Change Control, CAPA, Complaints, Nonconforming Materials and Products
Experience with Continuous Improvement, Lean or Six Sigma
Desired Experience / Qualifications / Skills:
SAP, EtQ and/or PeopleSoft experience
Experience with statistical analysis
Project management experience
Animal by-product import/export regulations
Animal health and/or virology, immunology, epidemiology knowledge
Soft Skills:
Ability to multi-task with ability to be organized
Strong interpersonal and communication skills
Strong time management skills and attention to detail
Ability to influence others in a team environment while collaborating with peers and functional areas
Ability to work independently with minimal supervision
Pay Transparency:
This is the pay range that Magnit reasonably expects to pay someone for this position is $40.18/hour - $53.57/hour.
Benefits: Medical, Dental, Vision, 401K (provided minimum eligibility hours are met).
QUALIFICATION/ LICENSURE :
Work Authorization : Green Card, US Citizen
Preferred years of experience : 3+ Years
Travel Required : 25% or less
Shift timings: 9 AM to 5 PM
Job Location
Woodland, California
Pay
USD 40.18 - USD 53.57 Per Hour
CONTRACT DURATION
11 month(s)
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