Quality Engineer II

San Diego, CA
Full Time
Quality Assurance
Mid Level

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 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.

Disclaimer

INOVIO Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, INOVIO will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, gender identity and expression, religion, marital status, registered domestic partner status, age, national origin or ancestry, military or veteran status, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

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.

Share

Apply for this position

Required*
Apply with Indeed
We've received your resume. Click here to update it.
Attach resume or Paste resume
Attach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) or Paste resume

Paste your resume here or Attach resume file

To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more.
Invitation for Job Applicants to Self-Identify as a U.S. Veteran
  • A “disabled veteran” is one of the following:
    • a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or
    • a person who was discharged or released from active duty because of a service-connected disability.
  • A “recently separated veteran” means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
  • An “active duty wartime or campaign badge veteran” means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
  • An “Armed forces service medal veteran” means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.
Veteran status


Voluntary Self-Identification of Disability
Voluntary Self-Identification of Disability Form CC-305
OMB Control Number 1250-0005
Expires 04/30/2026
Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Please check one of the boxes below:

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

You must enter your name and date
Human Check*