Senior Quality Assurance Specialist

Company: Bio-Techne
Location: Newark
Posted on: November 12, 2021

Job Description:

Job Details Level: Experienced Job Location: Newark - Newark, CA Position Type: Full Time Education Level: Bachelor's Degree Salary Range: Undisclosed Travel Percentage: Up to 10% Job Shift: Day Job Category: Quality & Regulatory Description By joining the Bio-Techne team you will have an impact on future cutting-edge research. Bio-Techne, and all of its brands, provides tools for researchers in Life Sciences and Clinical Diagnostics. Position Summary: Reporting to the QA Manager, the Senior Quality Assurance Specialist will work within a highly dynamic group to educate concepts, develop, establish, and train to ISO13485 and FDA Quality System Requirements. Our ideal candidate is a highly creative and energetic individual and is knowledgeable in compliance. Key Responsibilities: * Assist and support ACD with compliance to the Quality Systems, monitoring the conformance to applicable processes & standards. * This individual will be responsible for monitoring and improving the following quality system elements: CAPA, NCP, Process Change Control, batch record review & release, internal and external audits, quality metrics, management review, recalls, customer complaints, risk management, supplier control and customer related processes. * Work closely with QA Manager, Document Control, Research, Development, Manufacturing, Operations, Technical Support and commercial teams to identify and support the Quality System compliance and customer needs. Will take initiative and be willing to learn new technologies quickly and adapt to shifting priorities. * Other quality related duties as required by QA manager Qualifications Education and Experience: * Minimum of a Bachelor's Degree required and 5-10 years experience in Quality Systems * Understanding of IVD Medical Devices, Quality Management Systems (ISO 13485, QSR) development, implementation, compliance, as well as audits. * Fluent in CAPA, NCP, PCO, document control, audits, quality metrics, customer complaints, post-market surveillance/recalls, management review, design control and risk management. * Prior experience in process validation, supplier management, equipment control, and customer related processes are a plus. * Excellent computer skills, including working knowledge of common QA Document Control and QMS, ERP software and databases. * Excellent people, verbal and written communication skills. * Ability to thrive and flourish in a fast-paced growing start-up environment

Keywords: Bio-Techne, Newark , Senior Quality Assurance Specialist, Other , Newark, California