Job Description

Title: Sr. Quality Specialist

Location: Sunnyvale, CA

Job Type: 1-year Contract, Full-Time, On-Site (M-F: 1st Shift)

Compensation: $70-$80/hour (DOE) + Kelly Standard Benefits

Job Description:

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 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 US FDA, EU IVDR, and other global 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.
• Related work experience in Quality with a focus on assay development in a medical devices or pharmaceutical industry with applicable knowledge of cGMP, ISO, and FDA regulations (ISO 13485, ISO 14971, FDA 21 CFR 820 QSR)
• Experience in implementing design control and risk management, and product shelf-life activities.
• Experience with technical data and capable of making risk-based recommendations, taking into account broad perspectives that support both the regulations and the business.
• Adept with Microsoft Word, Excel, Visio, PowerPoint, and Minitab.
• Quality Systems/Quality Engineering background in molecular biology products or molecular diagnostic products utilizing PCR (preferred).

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