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Design Quality Engineer IINOVIO PHARMACEUTICALS INC • United States
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Design Quality Engineer I

INOVIO PHARMACEUTICALS INC
  • US
    United States
  • US
    United States
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Job Description
Job Description
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 Design Quality Engineer I plays a key supporting role within the product development organization by maintaining accurate, compliant design control documentation throughout the product lifecycle. This position ensures that design and development activities align with QMSR, ISO 14971 and ISO 13485 requirements, contributing to audit‑ready records and robust traceability. This role offers hands‑on experience with medical device compliance frameworks and cross‑functional collaboration. Essential job functions and duties Maintain D&D procedural framework to ensure alignment with QMSR, ISO 14971, ISO 13485, and 21 CFR Part 4 design and risk control requirements. Review and approve D&D documentation (e.g., design plans, design inputs/outputs,
verification/validation
records) under supervision. Ensure Design History File (DHF) completeness, including proper traceability, version control, and accessibility for internal audits and regulatory inspections. Support cross‑functional teams in preparing documentation for regulatory submissions (FDA, EU MDR, etc.). Assist in maintaining traceability matrices linking requirements, risks, verification, and validation activities. Participate in design reviews, capturing minutes, action items, and ensuring documentation accuracy. Help monitor and update design control metrics, logs, and trackers. Support continuous improvement of design control processes and templates. Minimum requirements Bachelor’s degree in engineering, life sciences, or related field. 1 -2 years of experience in medical device, biotech, or regulated industry. Basic understanding of medical device regulations (ISO 13485, QMSR/QSR, ISO 14971, 21 CFR Part 4 preferred). Ability to work cross‑functionally and manage multiple document workflows. Basic understanding of risk management tools (e.g., FMEA, hazard analysis) Proficiency with document control or QMS systems (e.g., Veeva, Master Control, Agile PLM) Comfort with Excel or data tracking tools for logs, metrics, and traceability matrices. 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.
  • United States

Sprachkenntnisse

  • English
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