Sr. Validation Quality Engineer

Company: Genalyte, Inc.
Location: San Diego
Posted on: January 16, 2022

Job Description:

Since 2007, Genalyte has been guided by a vision: to positively impact human health by disrupting conventional diagnostic techniques. Genalyte is disrupting the lab testing world by moving lab testing from the research lab into the physician's office.

We are well funded with outstanding growth potential. We are looking for individuals inspired by our technology and vision, who are eager to be at the ground level of this collaborative and entrepreneurial company.

We want to hire individuals who are interested in creating an innovative, fast-paced and dynamic work setting. We offer a competitive salary and benefits package to attract, motivate, and retain the highest caliber of employee.

About the role:

We are looking for a Senior to staff level Quality Engineer to support validation activities and the development, implementation, and the continual improvement of the Quality Management System. This position will work closely with cross functional teams to support Quality Assurance (QA) activities and initiatives, implement Quality Management System processes and procedures, and provide guidance and support to site-wide validation activities.

Principal Responsibilities

• Oversee validation projects and provide guidance at all stages, from initial planning throughout execution, review, and completion/approval of final reports.
• Partner with product validation teams to determine validation strategies based on acceptable risk-based approach and support sustaining validation activities.
• Provide oversight and guidance to equipment and process validation team members during the development and execution of manufacturing validation and qualification plans, protocols, and reports.
• Partner with subject matter experts to identify and define product specifications, sampling and testing requirements, stability processes, and assisting with investigations of clinical and commercial diagnostics and consumables manufactured by the company.
• Review and approve proposed design changes for products by performing risk assessments, providing guidance and support, and assessing the adequacy of verifications and validations.
• Lead and facilitate product and process risk management activities including facilitating risk assessments and FMEA with cross functional teams, maintaining risk management files, and participating in risk analyses associated with design changes, complaint handling, and failure analyses.
• Provide guidance and support to root cause, failure investigations, and corrective/preventive actions related to nonconformances identified through CAPA, post market surveillance, customer feedback, and provide product support as required to identify deficiencies in the quality system, product, and manufacturing processes.
• Provide quality oversight and guidance to medical device software, diagnostic instrument, and consumable product realization processes, ensuring adherence to company procedures and applicable ISO 13485:2016 and FDA design control (820.30) requirements.
• Assists with supplier, certification body, and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and Good Manufacturing Practices implemented by the company.
  
  Qualifications
  
  • Bachelor's degree or higher in a scientific field, 5+ years related experience, preferably in medical devices, pharmaceutical, or In Vitro diagnostics.
  • Extensive experience developing validation plans, protocols, and reports and providing oversight and guidance to validation activities.
  • Hands-on experience developing and implementing Corrective and Preventive Actions (CAPA) plans, leading root cause analysis (RCA), implementing continual Improvement initiatives and well-versed in problem-solving methodologies (Kaizen, Lean, Six Sigma, etc.).
  • Working knowledge of statistical tools and methodologies used to analyze data.
  • Working knowledge of Quality System Regulations and International Standards such as 21 CFR 11, 21 CFR 820, ISO 13485, ISO 14971, EN 62366, EN62304 and In Vitro diagnostics regulations.
  • Strong verbal and written communication skills.
    
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Keywords: Genalyte, Inc., San Diego , Sr. Validation Quality Engineer, Engineering , San Diego, California