Quality Control and Quality Assurance Manager

Warren, NJ

Prosidyan Inc., founded in 2009, is the creator and supplier of the next generation in synthetic bone grafting through its proprietary manufacturing process utilizing microscopic fibers of bioactive glass.

 

We have an opportunity for an experienced hands-on individual to join our team as a Quality Control & Quality Assurance Manager.  This position is responsible for the company’s quality systems and ensuring compliance with all applicable laws, regulations, and FDA requirements.  The ideal candidate will have 1-5 years of experience in a regulated industry such as Medical Devices or biologics with experience in quality control and quality assurance systems.  May be the perfect opportunity for a Medical Device quality professional looking for that next step in their career.

 

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

 

  • Responsible for the sterilization validations and dose audits, test method validations, customer complaints, CAPA, document control, supplier quality, disposition and investigation of nonconforming materials, DHR review and lot release, incoming inspections and employee training in accordance with quality assurance procedures.
  • Prepare and conduct monthly quality meetings and represent quality at Management Review meetings and keep management informed of quality issues.
  • Collect and perform trend analysis of manufacturing, shipping, sterilization data.
  • Perform internal audits and/or supplier audits as needed.
  • Develop sampling plans and statistical techniques.
  • Calibration of test equipment and gages, maintain records and work with calibration vendors.
  • Perform process validations (IQ, OQ, PQ) including writing protocols and reports.
  • Perform product and packaging tests, shelf life studies.
  • Post market review of products.
  • Represent the company during customer visits, audits, and inspections.
  • Act as a liaison with regulatory agencies (FDA, ISO, other) during quality system inspections and/or audits.
  • Drive continuous improvement and optimization of the Quality Management System.

 

QUALIFICATIONS INCLUDE:

 

  • Bachelors or Masters in Engineering (quality, biomedical, mechanical).
  • 1-5 years of experience in Medical Devices or biologics with experience in quality control and quality assurance systems.
  • Experience with quality system regulations: cGMP, 21 CFR 820, QSR, ISO 13485, CMDR, MDD.
  • Experience with validation (IQ, OQ, PQ).
  • Experience with FDA establishment inspections and ISO audits.
  • Creative problem-solving skills
  • Proficient with Microsoft Word, Excel, PowerPoint and statistical analysis software.
  • Ability to work independently.

 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

 

To Apply:   https://www.indeedjobs.com/prosidyan-inc?hl=en_US