Quality Engineer III in San Diego, California at INOVIO PHARMACEUTICALS INC

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. INOVIO’s 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 www.inovio.com.

Job summary

The Quality Engineer III provides quality engineering leadership and technical support for INOVIO’s electromechanical medical devices and combination products throughout manufacturing, testing, release, and post-production quality activities. This position independently manages complex quality engineering assignments, including nonconformance investigations, material review and disposition, corrective and preventive actions, supplier quality, change control, quality-system documentation, inspection methods, and continuous improvement initiatives.

The Quality Engineer III applies engineering principles, risk-based decision-making, statistical methods, and knowledge of applicable regulatory and quality-system requirements to evaluate product, process, and supplier quality issues. The position is responsible for developing technically sound and audit-defensible conclusions, recommending appropriate containment and corrective actions, and ensuring that quality records are complete, accurate, traceable, and supported by objective evidence.

The Quality Engineer III collaborates with Engineering, Manufacturing, Quality Control, Supply Chain, Regulatory Affairs, and external suppliers to resolve quality issues and maintain product, process, and regulatory compliance. This role exercises independent technical judgment, leads cross-functional activities without direct authority, communicates quality and compliance risks to management, and performs assigned responsibilities with minimal supervision.

Essential job functions and duties

• Lead or independently manage nonconformance investigations, including containment, potential root causes, risk assessment, product disposition, verification of actions, and closure.
• Lead or support Material Review Board activities and ensure that product and material dispositions are technically justified and properly documented.
• Lead or support CAPA and ISSUE activities, including investigation, root causes determination, action planning, implementation, and effectiveness verification.
• Identify recurring or systemic quality issues and recommend escalation through the appropriate quality-system process.
• Lead or support supplier-quality activities, including supplier investigations, SCARs, corrective-action review, supplier changes, qualification, monitoring, and audits.
• Review supplier failure analyses and coordinate appropriate containment, screening, inspection, return, replacement, or corrective actions.
• Review Device History Records, inspection records, test results, and supporting documentation to support product and component release decisions.
• Provide technical support for incoming, in-process, and finished-product inspection, including interpretation of drawings, specifications, tolerances, and acceptance criteria.
• Support development and improvement of inspection methods, sampling plans, measurement systems, quality plans, and manufacturing controls.
• Develop and revise quality-system procedures, work instructions, forms, and electronic workflows.
• Analyze and present quality metrics and trends related to nonconformances, supplier performance, recurring defects, and investigation status.
• Serve as a Quality Engineering subject matter expert during internal audits, supplier audits, regulatory inspections, and inspection-readiness activities.
• Lead cross-functional quality activities, communicate significant risks to management, and provide technical guidance and mentoring to less-experienced personnel.
• Perform other duties consistent with the responsibilities and level of the position.

Minimum requirements

• Bachelor’s degree in engineering, science, or a related technical discipline, or an equivalent combination of education and directly relevant experience.
• Minimum 5+ years of progressive experience in quality engineering, manufacturing engineering, supplier quality, or a related technical function within the medical-device, biotechnology, pharmaceutical, combination-product, or another regulated industry.
• Demonstrated experience independently leading nonconformance investigations, material review and dispositions activities, CAPA activities, supplier quality issues, and cross-functional quality projects.
• Working knowledge of applicable FDA quality-system and current good manufacturing practice requirements, ISO 13485, and ISO 14971. Familiarity with 21 CFR Part 4 and combination product requirements is preferred.
• Experience applying root-cause analysis, risk assessment, statistical methods, inspection processes, and problem solving techniques to quality and manufacturing issues.
• Ability to analyze technical information and make sound, risk-based quality recommendations supported by objective evidence with limited supervision.
• Demonstrated ability to lead cross-functional activities and drive assigned actions to completion without direct authority.
• Proficiency with Microsoft Office applications and experience with electronic Quality Management Systems (eQMS), such as MasterControl or equivalent.
• Experience with electromechanical medical devices, electronic assemblies, contract manufacturers, statistical software, or automated inspection equipment is preferred.

Disclaimer

INOVIO Pharmaceuticals, Inc. is an Equal Employment Opportunity Employer, including but not limited to veterans and individuals with disabilities. We prohibit discrimination of any kind. In keeping with our policy, we recruit, hire, train, and promote the most qualified individuals for all job titles, and we provide equal opportunities to all employees and applicants for employment.

A current US work authorization is required. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. INOVIO offers an attractive benefits package and is an equal opportunity employer.

Important notice to employment businesses/agencies

INOVIO does not accept referrals from employment agencies unless written authorization from the INOVIO Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore INOVIO will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at INOVIO.