Novan
  • 25-Sep-2017 to 24-Nov-2017 (CST)
  • Durham, NC, USA
  • Full Time

Purpose:

The Quality engineer will perform product, process and equipment validations/qualification, medical device design and development document writing and review, and other quality related activities with minimal guidance and supervision. Has broad knowledge of commonly used concepts, practices, and procedures within validation and quality assurance field.

 

Principal Responsibilities:

  1. Own the site Change Control Progam, providing technical expertise while working closely with other functions to assure timely and effective change management.
  2. Act as Quality Representative and primary reviewer on design and development projects
  3. Develop, deploy and execute validation programs and procedures, including scheduling and maintaining the requalification and periodic review program
  4. Work closely with Process Engineers to develop, perform, review and approve process, test method and equipment validation/qualifications, including software and automation/controls.
  5. Perform product and process evaluations to identify areas for improvement. Recommend solutions to identified problems. Implement approved changes using sound quality engineering principles and fully document requirements.
  6. Review product and process changes for effect on existing validations, recommend and perform revalidations as required.
  7. Oversee and provide technical input for method development, qualification [measurement system analysis (MSA's)], as well as method transfer for all critical performance test methods.
  8. Support Risk Assessment activities including User-, Design-, and Process- FMEAS in order to proactively identify and mitigate risks through appropriate control strategies and risk mitigation plans.
  9. Participate in design reviews and provide expert Quality/technical input to ensure potential problems are identified and corrected early in development to minimize impact to broader project scope/resources/budget.
  10. Provide supervision for contract validation resources as needed to support the business

 

Qualifications:

  1. Education
    • Bachelor of Science in pharmaceutical applicable filed. Examples may include Science, Biology, Chemistry, Engineering.
  2. Experience
    • Minimum of 6 years of (regulated) Product Development and/or Quality Engineering experience in the Medical Device, Pharmaceutical or Biotechnology industry.
  3. Skills
    • In-depth knowledge of 21 CFR P Part 4, Part 11, Parts 210/211, Part 820 is required
    • Strong analytical, technical writing, verbal communication and interpersonal skills are required
    • Working knowledge of quality systems, validation principles for product and manufacturing processes, Computer Systems and strong engineering design fundamentals is required (ASTM E2500, GAMP5, V-Model, CSV, etc.)
    • Thorough understanding of regulations, familiarity of regulatory environment and industry trends for combination products is required.
    • Working knowledge of design history files for combination products is required
    • Working competency of statistical programs (i.e., Minitab, SAS, etc.) is required
    • Certified Quality Engineer (CQE) preferred Certified Six Sigma Green/Black Belt or equivalent preferred

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

In the typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, use hands and fingers (i.e. typing) and occasional lifting up to 20 pounds.

 

Novan, Inc. maintains a drug-free workplace and performs pre-employment and employment substance abuse testing and background verification checks.

 

Novan, Inc. is an equal opportunity employer and does not discriminate against any employee or applicant for employment. We encourage and foster diversity in the workplace.

Novan
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