Quality Assurance Specialist

4 weeks ago

San Diego, California, United States Inovio Full time
About INOVIO
INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. Our technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit our website.

Job Summary
The Quality Engineer II is responsible for ensuring the quality of our products and processes. This includes developing, maintaining, and analyzing supplier quality systems and procedures to ensure compliance with FDA regulations, corporate directives, ISO 13485 standards, and company strategies. This position also involves providing quality input, technical support, conducting investigations, and providing guidance for Manufacturing, Engineering, and Regulatory Affairs.

Key Responsibilities
Participate in MRB meetings and follow through on daily activities around non-conformance investigations, root causes, and corrective actions.
Lead and/or assist with in-depth non-conformance/failure investigations to determine true root cause and assist in identifying appropriate corrective actions.
Lead or participate in product, component, or assembly qualifications at suppliers.
Manage and drive improvement of the Supplier Quality Rating and Certification System.
Lead and participate in Supplier Quality Management assessment and qualification.
Lead and take an active role in developing and overseeing supplier transition and outsourcing plans as needed.
Coordinate with Purchasing, Manufacturing, and Engineering to ensure Supplier selection, qualification, and ongoing maintenance to meet/exceed corporate and regulation requirements.
Participate in Batch Record/Device History Record review (DHR), release of manufacturing product and components at various stages.
Report discrepancies to management to drive process improvements.
Serve as a CAPA assistant with any investigations.
Perform dimensional inspection using standard quality measuring equipment, such as Keyence or applicable programmable automated inspection equipment.
Provide feedback for problems occurring in the processing of manufacturing assemblies and testing of products and develop changes and corrections to prevent recurrence.
Assist in inspection and testing methods and participate in the preparation of quality assurance specifications and procedures to implement such methods.
Participate in the review of engineering specifications to ensure that adequate quality assurance requirements are met.
Review drawings for adherence to design inputs, material callouts, and standards and procedures, and verify that required reports are attached so that the project can proceed to the next phase.

Requirements
Bachelor's degree in quality assurance or engineering or a related field is preferred, or the equivalent combination of education, training, and experience from which comparable knowledge, skills, and abilities have been attained. Experience in the medical device industry is preferred, with an in-depth understanding of GMP/QSR/ISO/MDD/MDR regulations, focusing on inspection points and compliance to specifications. A minimum of 2 years of emphasis on Supplier Audits and implementation of Supplier Qualification is required. Experience with alternative Quality-related tools, such as D and P, FMEA, QFD, SPC, Risk Analysis, DOE, and TQM, is also a plus. Proficiency in Microsoft Word, Excel, and Outlook, Visio, PowerPoint, Visual Basic, Access, and Mini-Tab or other comparable statistical analysis software application is required. Familiarity with investigational tools, such as 5-Whys, Fishbone Diagrams, Turtle Diagrams, etc., is a plus. Detail-oriented and organized in meetings and reviews, with the ability to write reports, business correspondence, and procedure manuals, is required. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form, and ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists, is required. Proven project management skills, with the ability to complete technical projects with limited supervision, is a plus. Have organizational, communication skills, and the ability to perform varied tasks in a disciplined, consistent manner, is required. Ability to work in a fast-paced and team environment is a must.

What We Offer
INOVIO offers a variety of competitive compensation and benefits to regular full-time INOVIO employees, including a 401(K) retirement plan with corporate matching, annual incentives, medical, dental, and vision, a generous paid-time off program and company holidays, a hybrid work environment, physical, mental, and financial wellness programs, company-paid life insurance plans, long and short-term disability, flexible spending accounts for medical and dependent care expenses, employee discount perks, and so much more. The annualized base salary range for this role is $95,862 to $110,000 and is bonus eligible. Individual pay decisions ultimately depend on various factors, including relevant experience, knowledge, skills, education, geography, internal equity, and alignment with external market data.

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