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Director of Quality Assurance

Cytek Biosciences, Inc Fremont ,CA
  • Posted: over a month ago
  • Full-Time
  • Benefits: 401k, dental, life_insurance, medical, vision
Job Description

Job Title: DIRECTOR OF QUALITY ASSURANCE

MAJOR DUTIES AND RESPONSIBILITIES:

Direct the Quality Management System at Cytek Biosciences in compliance with ISO9001, ISO13485, GMP, and FDA QSRs, Global, US and California state requirements to ensure product efficacy, safety, and quality. The Director of Quality Assurance is responsible for the accuracy, currency, compliance, and improvement of the following key elements;

  • Quality Management Systems
  • Quality Policy, Quality Objectives, Quality Manual
  • Product Life Cycle Management
  • Design and Document Control
  • Organizational Structure and Responsibilities
  • Data Management
  • Customer Satisfaction
  • Company Processes
  • Quality Instruments
  • Product Quality
  • Continuous Improvement
  • Risk Management
  • Quality Metrics Reporting

The Director of Quality is responsible for the identification, hiring, job assignment, training, and development of the QA and QC staff members. This will include responsibilities for transfers, promotions, salary changes, performance reviews, and terminations. They will create departmental objectives and goals and establish accountability for their achievement. The Director of Quality is responsible for unified deployment of quality processes across all of Cytek’s subsidiary locations.

They are responsible for conducting periodic Management Reviews and the overall management of internal audits, regulatory inspections (FDA, ISO, UL, CE) , Notified/Certification Body audits, corrective and preventive actions, post market surveillance, document controls, training, effective data collection and reporting of Quality metrics. The Director will develop inspection readiness plans and train audit teams for front room and back room activities. They will ensure that pre and post-inspection activities are completed including scheduling, record review, training, and logistics. Will provide oversight in the preparation of responses to audit nonconformities. Organizes audits on a timely basis to ensure compliance with appropriate standards and regulations for the development, manufacture, release, and support of all products.

The Director of Quality Assurance will assist with the implementation of Incoming QC Inspection, In-Process QC Inspection, Final QC Inspection, QC Test and Supplier Quality Management. They are responsible for the management of Non-Conforming Material, Supplier Corrective Action and the Incident Reporting/Customer Complaint process at Cytek to ensure root cause analysis, preventive and corrective action plans are created and implemented in compliance with any Regulatory or company standards. Support and drive key product and process changes and improvements in manufacturing relating to product quality. Confirm the adequacy of applicable Process Validation studies on the Production floor. The Director will have oversight of the Complaint System, MDR process and Material Review Board for NCMR and RMA Materials. The Director will ensure that product inventory that is in their care will accurately accounted for and processed though the IQC, NCMR, and RMA processes.

The Director of Quality will create, submit, and monitor the departmental budget ensuring adherence to company spending objectives. They are responsible for the compliant use of business systems supporting QMS and PLM.

EDUCATION REQUIREMENTS:

  • Bachelor's Degree in an Engineering or Science major Preferred.
  • Professional certification is preferred (i.e, CQA, CQE, SQE, CQM, Six Sigma)

EXPERIENCE QUALIFICATIONS:

At least 5 years of Managerial experience in the Life Science, Pharmaceutical, Diagnostic or Medical Device industries. Medical Device experience particularly with Quality’s role in FDA and ISO regulations preferred. Experience working with multi-sub-system equipment including electronic, optical, fluidic, and application software sub-systems is a plus. Demonstrated experience with technical document creation. Experience using the Windows OS, MSOffice Applications, Engineering Change Order Systems, Device History Records, and the creation of Procedures and Reports. Demonstrated ability to motivate and manage exempt and non-exempt Quality System personnel.

KEY SKILLS AND COMPETENCIES:

Knowledge of US and International regulations and standards that apply to the in vitro diagnostic and medical device industry, including FDA Quality Systems Regulations, ISO 13485 & 9001 & 14971, EU MDD/IVD, EU MDR/IVDR, SOR/98-282, TG(MD)R, RDC 16, Ordinance #169. Knowledgeable in manufacturing techniques and processes. Demonstrated verbal and written communication skills. Problem solving, analytical, creativity, and critical thinking skills.

PHYSICAL REQUIREMENTS:

Individual will be required to be able to work in a standing position for an hour at a time.

Company Description
Cytek Biosciences Inc. is the outcome of a merger between Cytek Development Inc, a leading pioneer in flow cytometry, and Cytoville Inc, a venture capital backed business in advanced medical instrument technology development. Cytek was founded by Dr. Eric Chase 25 years ago, and is a leading manufacturer and supplier of flow cytometry products and services. We are engineers, scientists and customer service representatives who design, build and support flow cytometers. Cytek Biosciences is backed by Cowin Healthcare Fund, Easy Prosperity and Fidelity Biosciences.

Our mission is to create innovative products and services which lead to scientific discovery.
Our novel, cost-effective products assist labs around the world to operate safely and efficiently. Cytek's products add functionality to existing flow cytometry equipment, extending its usable life. Our onsite support services, provide cost effective maintenance solutions for a broad range of laboratories.

As a Company, we seek to maintain high ethical standards and a culture that values honesty, integrity and transparency in all that we do. Company decisions are driven by what is right for scientific discovery and customer support. We are committed to our employees, to the environment in which we live and to the communities we serve worldwide.

Cytek Biosciences, Inc

Cytek Biosciences Inc. is the outcome of a merger between Cytek Development Inc, a leading pioneer in flow cytometry, and Cytoville Inc, a venture capital backed business in advanced medical instrument technology development. Cytek was founded by Dr. Eric Chase 25 years ago, and is a leading manufacturer and supplier of flow cytometry products and services. We are engineers, scientists and customer service representatives who design, build and support flow cytometers. Cytek Biosciences is backed by Cowin Healthcare Fund, Easy Prosperity and Fidelity Biosciences. Our mission is to create innovative products and services which lead to scientific discovery. Our novel, cost-effective products assist labs around the world to operate safely and efficiently. Cytek's products add functionality to existing flow cytometry equipment, extending its usable life. Our onsite support services, provide cost effective maintenance solutions for a broad range of laboratories. As a Company, we seek to maintain high ethical standards and a culture that values honesty, integrity and transparency in all that we do. Company decisions are driven by what is right for scientific discovery and customer support. We are committed to our employees, to the environment in which we live and to the communities we serve worldwide.

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