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 provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.

Kevin Suk at
343 Main Street
El Segundo, CA 90245

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

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