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Senior Reagents Quality Specialist/Engineer, New Product Introduction

Company: Danaher
Location: Sunnyvale
Posted on: July 14, 2019

Job Description:

Job Description Description Job Description Summary This position supports quality systems activities related to assay development, especially design control and risk management activities in accordance with FDA and ISO regulations. The ideal candidate will have a Quality Systems/Quality Engineering background in molecular biology products or molecular diagnostic products utilizing nucleic acid amplification tests (e.g. PCR). Job Description Duties and Responsibilities: 1. 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. 2. Provide guidance to stability testing, test methods, sample plan definition, and validation development. 3. Fulfill all quality planning, stability, and risk management deliverables with feedback from cross-functional teams. Represent the extended Quality Systems team to the product development teams. 4. Ensure required documentation is completed prior to new product launch. 5. Provide Technical Quality support 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. 6. Work with management for continuous improvement of the Quality Systems, including the design control, risk management, document generation, and design testing processes. Qualifications Knowledge and Skills: 1. B.S. in Chemistry, Biology, or related physical or biological science field. 2. Minimum of 5 years 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. 3. Experience in implementing design control and risk management activities. Strong knowledge of process validation in reagent assay products. 4. Knowledge of design of experiments. Excellent problem solving and analytical skills. Comfortable with technical data and capable of making risk-based recommendations taking into account broad perspectives that support both the regulations and the business. 5. Effective interpersonal and communication skills, and capable of representing Quality Systems to, and forming strong working relationships with, functions such as Research & Development, Engineering, Technical Operations, Regulatory Affairs, and Project Management. 6. Capable of multitasking and prioritizing several projects independently (project management-like skills).

Keywords: Danaher, Sunnyvale , Senior Reagents Quality Specialist/Engineer, New Product Introduction, Engineering , Sunnyvale, California

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