166591,  Engineer II - CA -

Category: ENG
Job Title: Engineer II - CA
Region: CA-Southern California - San Diego
City: Pleasanton
State: CA
Rate: Up to $31.16 DOE
Duration: 13 Months
Description: Chipton-Ross is seeking an Engineer II for an opening in Pleasanton, CA

-Provide quality services to projects ensuring that dependable scientific method is employed and that design history and/or project files comply with established requirements
- Support development and executions of process verification and validation plans Reviews and approves planned and unplanned changes/deviations
-Review and resolve nonconforming material investigations through coordination of efforts across operations and at incoming

-Develop, review and approve Quality System documents (e.g., Standard Operating Procedures, Forms, Specifications, Validations, etc.) to ensure compliance with applicable regulations (e.g., QSR, ISO, etc.)
-Ensure integrity of Quality System processes (e.g. CAPA, internal audit, etc.) in order to maintain facility certifications (i.e. ISO)/Review batch records (regulated and non-regulated). Perform activities for Regulated Product Release, as applicable.
-Assist with audits of the quality system to determine compliance to domestic and international regulations
-Monitors and analyzes nonconformity to identify products or processes requiring quality improvements
-Review metrics, complaints and returned products to identify trends and recommend corrective action if required- Coordinates the implementation of corrective actions and verifies effectiveness.
-Identifies and/or provides appropriate training on ISO elements (e.g. Risk Assessment, Design Control, etc. if necessary)
-Constantly strive to enhance efficiency in procedures and processes without a compromise in quality

-Strong oral and written communication skills with a demonstrated ability to work in a cross-functional team environment and to effectively interact with all levels in the company.
-Effective communication skills and the ability to communicate with internal and external customers are essential.
-Proficient in MS Office and Data Management Previous experience in an ISO 9001 or 13485 compliant manufacturing environment or experience with FDA Medical Device Regulations.

-Previous experience with SAP or Oracle Enterprise 1 ERP systems

-A candidate for this position shall have a BS degree in Biology, Biochemistry, Chemistry, Genetics, or Molecular Biology with 3 years of workplace experience in a regulated environment.

Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.

Chipton-Ross is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

Kevin Suk at
343 Main Street
El Segundo, CA 90245

Phone: (310) 414-7800 x230 or (800) 927-9318 x230

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