Get Biology JobsGet Biology Jobs

Principal Quality Engineer III

Job Title:Principal Quality Engineer III
Job ID:7454
Location:Carlsbad CA 92008
Duration:12 Months

Summary of position:
Manage maintaining the sites Quality System, including: developing, establishing and continuously improving site CAPA system, quality assurance programs, quality policies, investigation and trending of quality data streams.
Responsible to drive compliance based programs to ensure the Quality Department supports internal and external customer requirements. Internal customer groups will rely heavily on you to make data driven and highly technical decisions in a timely manner and provide the support necessary to carry out those decisions.

Drive technical and compliance understanding of quality processes associated with quality, CAPA, deviations/exceptions, root cause analysis, change control and quality concepts in a distribution center/commercial office environment.
Manage finished products release and ensure all cGMP requirements are fulfilled for released of finished goods in accordance with regional regulatory requirements.
Review, assist in the development and locally implements relevant SOPs related to Pharmacovigilance (PV), medical device vigilance, product complaint, product recall, medical inquiries, PV agreement with distributors etc.
Based on directives given by product monitoring, coordinates product recalls and provides relevant reports regarding the recalls to regional regulatory authority.

Familiarity with Quality Management Systems, particularly management review and analysis of data requirements.
Above average communicator and collaborator with basic leadership skills.
Proven experience working across functions and geographies.

Bachelors degree in related field.
Preferred: Advanced degree in related technical field.
8+ years of related work experience.
Direct experience with regulatory requirements and quality processes, experience with managing FDA (or Notified Body) inspections.
Software and automated process validation skills a plus. Previous experience managing CAPA process strongly desired.
FDA/ ISO/ GMP knowledge base (ISO 13485 and 21 CFR 820 knowledge a strong plus).
CQIA (ASQ), CQE (ASQ), CSQE (ASQ), and/or Six Sigma Green Belt.
Experience in the medical device or biopharmaceutical industry.

Contact Person: Manju

If you are interested in this position then you can reach me at 2015249600 X 7944
Good news! We have your resume on file, you can use our Quick Apply function to easily apply to this job.

Critical Need Jobs

Employer Information

Previous Page New Search

You're doing a good job! I am always checking out your updated postings. Thanks a lot.

Ronell Seracarpio, Laboratory Assistant

Join 2,655 other Biology Professionals receiving FREE weekly job listings to their inbox every week.

We value your privacy. We will not rent your email to anyone.

Browse other Biology Jobs

  1. Senior Scientist, Biology

    02.18.18 San Diego County, CA
    Vividion Therapeutics is seeking a highly-motivated Senior Scientist, Biology to contribute to the...
  2. Scientist, Cancer Biology

    02.18.18 Bothell, US
    seeking a highly talented and motivated scientist with a strong cancer biology and/or cell biology...
  3. Associate Scientist, Genome Biology

    02.18.18 San Diego County, CA
    a full-time position reporting to the Sr. Scientist of Genome Biology and it is located at our...
  4. Research Associate-Molecular Biology

    02.18.18 South San Francisco, CA
    -paced, multidisciplinary environment encompassing molecular biology, protein expression, and...
  5. Research Associate, Cell Biology

    02.18.18 Berkeley, CA
    combining synthetic biology, cell biology, molecular and medical imaging to create disruptive products for...
  6. Research Associate - Molecular Biology

    02.18.18 Duarte, CA
    opportunity for a  Research Associate �" Molecular Biology  to join our team.  We use our pioneering...
  7. Research Associate - Biology

    02.18.18 South San Francisco, CA
    further extend our pipeline of novel drug candidates.    The Biology Department is seeking a...
  8. Sr. Bioinformatics/Computational Biology Scientist

    02.18.18 Bothell, US
    and Computational Biology group at Seattle Genetics to contribute to the development of innovative...

    02.18.18 South San Francisco, CA
    SENIOR RESEARCH ASSOCIATE (CELL BIOLOGY)   The Senior Research Associate will have...
  10. Research Scientist-Pancreatic Islet Biology

    02.18.18 Indianapolis, IN
    expertise in islet cell biology? Are you a passionate and dedicated scientist with diabetes complication...
Previous Page New Search