ZebraSci is searching for a talented Quality Engineer to work at our site in Temecula, CA. This role is primarily responsible for leading complex root cause failure investigation and troubleshooting of customer complaints and product non-conformances. Strong technical aptitude and experience is a must, preferably in engineering, chemistry, biology or other life sciences field. High level of technical writing ability is required. This position is responsible for writing experimental protocols and reports, failure investigation reports, and supporting documentation within the Quality System (NCMR’s, Complaints, CAPA, Deviations, FMEA, Quality Plans etc.). This position will regularly present to external customers and peers with updates on failure investigation and troubleshooting activities. Experience interacting with Regulatory Bodies (FDA, ISO) is required. The use of data in decision making is essential. Advance skills in statistical techniques and tools is a must. The ideal candidate is a champion of Quality System compliance with a deep understanding of medical device QSR’s.

Essential Duties:

Provide leadership in performing and documenting root cause failure investigation activities for our contracted clients.
Write/edit/approve method development and method transfer reports.
Write/edit/approve QC investigation reports.
Present Failure Investigation findings to contracted clients and management.
Mine data for development of corrective actions.
Represents the Quality Control department in evaluating failures, performing technical root cause analysis and developing and executing corrective and preventative actions.
Perform statistical analysis of data from experiments and manufacturing process trend monitoring.
Evaluation and improvement of Quality Control plans through the entire manufacturing process optimization, matrix testing, and in-process testing of strips and components.
Supports Receiving/Inspection functions with creating / reviewing raw material specifications.
Prefer a B.S. in Engineering/Chemistry/Biology/Technical Discipline or equivalent combination of certification and work experience.

Experience in Quality and Manufacturing Systems in Laboratory or Medical Device industries.

ZebraSci Background:
Medical Device and Biopharma firms have gained an edge utilizing ZebraSci’s Medical Device development services and innovative inspection equipment. From Compliance, Regulatory and Human Factors to our ISO 17025 accredited COMBINATION PRODUCT testing lab and technologies, ZebraSci is your partner in success. The team at ZebraSci is comprised of cross functional teams that are passionate about developing and launching combination products. ZebraSci offers consultation, project management and test solutions throughout the entire product life-cycle; ensuring your product is launched, on time, on budget, and in compliance with ISO 13485 and FDA 21 CFR 820 Our experienced team has provided solutions for drug delivery devices and combination products for nearly ten years. Our cross-functional team is geared to deliver thoughtful, integrated solutions to your device projects. By combining experience, a unique methodology, customized tools and a passion for results, we help our clients produce tangible results from strategy through launch and beyond.