Title: Sr. Quality Specialist

Location: Sunnyvale, CA- 100% onsite

Shift: Monday-Friday, standard working hours

Pay: $64-$84/hour

Overview:

The Sr. Quality Specialist is responsible for supporting quality systems activities related to assay development, especially, design control and risk management activities in accordance with FDA and ISO regulations. This position is part of the Product Lifecyle Quality group in R&D and reports to the Sr. Manager, Product Lifecyle Quality and will be onsite based, located in Sunnyvale, California.

Responsibilities:

• Participate as Quality representative on select product development teams which includes providing guidance for Market Specification, Functional Specification, Design Verification, Design Validation, Test Method Validation, Risk Assessments, and Design Reviews; and provide guidance and decisions on product development activities to ensure continued compliance with internal procedures and applicable ISO and FDA standards.
• Provide design control guidance to junior NPI Quality specialists and provide technical oversight of product shelf-life/stability program.
• Fulfill all quality planning, stability, and risk management deliverables with feedback from cross-functional teams.
• Ensure required documentation is completed prior to new product launch, and coach product development teams to successful completion where necessary.
• Provide technical expertise for post market investigations and design changes, including documentation of investigations following standard out of specification SOPs and assessment of changes using design control methods.

Requirements:

• B.S. degree with 5 years of related experience or M.S. degree with 3 years of related experience, degree in Chemistry, Biology, or related physical or biological science field.
• Experience in Quality with a focus on assay development in a medical devices or pharmaceutical industry.
• Knowledge of cGMP, ISO, and FDA regulations. Specifically ISO 13485 and ISO 14971
• Experience in implementing design control and risk management activities.
• Quality Systems/Quality Engineering background in molecular biology products or molecular diagnostic products utilizing PCR (preferred)