Quality System & Compliance Specialist III

Job ID: JM20131402-25762
Requirements:
Expertise Quality Assurance
Education Bachelors
Job Type Full-time
Location United States - California - Fremont
Job Level Experienced
Description:
Posting date: February 14, 2013
Position Summary:
Conducts validation/process characterization studies, gauges R&R studies, drives design control/technology transfer activities, and failure investigations. Provides guidance on equipment, process validation, and design control requirements related to new product development projects.
Key Responsibilities:
* Supports/conducts IQ, OQ, PQ validation studies of equipment and processes, including some software related validations (i.e. spreadsheets); participates on technical project teams as subject matter expert on validation regulations; develops/reviews and approves validation protocols and final reports.
* Designs process characterization studies (DOE), conducts statistical analysis of results to identify critical parameters and improves process capability.
* Supports technical troubleshooting/failure investigations involving manufacturing non-conformances and product failures by leading or participating in FMEA, Hazard Analysis, and Fish Bone technical reviews.
* Participates on Design Control New Product development teams; advises the team on design control requirements; develops, reviews and approves design control deliverables.
* Optimizes the Quality System Validation and Design Control programs.
* Ensures conformance to in-house specifications and GMP.
Minimum Requirements/Qualifications:
* 5 – 8 years of work experience in Quality Systems within a regulated/medical device environment
* Bachelor’s Degree in chemical engineering, process engineering, or material sciences
* Thorough understanding of cGMP and ISO requirements, specifically validation and design control regulations
* Advanced statistical skills with the ability to analyze data, interpret results and write technical reports with a strong attention to detail
* Previous experience in a regulated environment validating software systems
* Excellent communication and interpersonal skills with the ability to interact with all levels of the organization and negotiate others
* Strong analytical and troubleshooting skills with experience in FMEA, Hazard Analysis, and Fishbone or similar failure investigation methodologies
* Superior organizational skills with the ability to manage time effectively and prioritize work
Non-Negotiable Hiring Criteria:
* Strong analytical and problem solving skills with attention to details
* Communication skills both verbal and written
* Computer skills including MS Office, flowcharting, artwork (Photoshop, Adobe, or others), file management and statistical software