Quality Engineer II

Job summary

The Quality Engineer II is hands-on with Quality System elements such as NCMR’s, CAPA’s, Batch (DHR) release, change orders, drawing review, quality inspection records, and product disposition. The Quality Engineer II is responsible for 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 is also responsible for Quality input, technical support, conducting investigations, and providing guidance for Manufacturing, Engineering, and Regulatory Affairs, especially as related to product and components from suppliers.
This position is responsible for performing investigations and inspections as necessary and identifying and implementing quality assurance testing models for analysis of raw materials, materials in process, and finished products. The Quality Engineer II assists in developing quality control policies and evaluates production challenges and determining improvement opportunities.

Essential job functions and duties

• Participate in MRB meetings with follow-through on daily activities around non-conformance investigations, root causes and corrective actions.
• Leads and/or assists 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 i.e. 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 regulatory and QS requirements; verify that required reports are attached so that the project can proceed to the next phase.

Minimum requirements

• Bachelor’s degree in quality assurance or engineering or a related field 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.
• 5 – 7 years of experience in Quality in a medical device manufacturing environment preferred with an in-depth understanding of (GMP/QSR/ISO/MDD/MDR) regulations a plus, with focus on inspection points and compliance to specifications Minimum of 2 years of emphasis on Supplier Audits, and implementation of Supplier Qualification
• Experience with alternative Quality related tools (D and P, FMEA, QFD, SPC, Risk Analysis, DOE, and TQM) 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.
• Familiar with investigational tools such as 5-Whys, Fishbone Diagrams, Turtle Diagrams, etc.
• Detail-oriented and organized in meetings and reviews.
• Basic understanding of statistical controls is a plus.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Proven project management skills; able to complete technical projects with limited supervision.
• Have organizational, communication skills and the ability to perform varied tasks in a disciplined, consistent manner.
• Ability to work in a fast-paced and team environment.

INOVIO offers a variety of competitive compensation & benefits to regular full time INOVIO employees including:

• 401(K) retirement plan with Corporate Matching
• Annual Incentives
• Medical, Dental, and Vision
• Generous Paid-time off program and company holidays
• Hybrid work environment (Depending on the nature of your employment with INOVIO)
• Physical, Mental, & Financial Wellness Program
• Company-paid Life Insurance plans
• Long & 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, but not limited to, relevant experience, knowledge, skills, education, geography, internal equity and alignment with external market data.