Director of Quality

Warren, New Jersey

 

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 Director of Quality.

This position will have overall responsibility for the company’s Quality Management systems and processes and ensuring compliance with all applicable laws, regulations, and FDA requirements.  In addition, this position will lead the Operations team responsible for logistics and customer service operations.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Develop and implement quality strategy and objectives in compliance with all applicable procedures, laws, regulations and FDA requirements.
  • Develop, implement and manage quality planning, inspection methods and defect prevention/ corrective action processes.
  • Ensure that the company meets its defined quality objectives.
  • Drive continuous improvement of the quality system through performance metrics.
  • Responsible for the management, development, training and leadership of Quality & Operations staff.
  • Prepares and manages Quality and Operations department budget.
  • Oversee and conduct validations and dose audits.
  • Represent the company during customer visits, audits, and inspections.
  • Lead the Operations Manager and team in inventory management, customer order and service activities.
  • Support company regulatory affairs.
  • Support company manufacturing operations.

 

QUALIFICATIONS INCLUDE:

  • Master’s in Engineering (quality, biomedical, mechanical) with certifications such as Certified Quality Engineer (CQE) certification or Certified Quality Auditor (CQA), CQM, etc.
  • 10+ years of quality control and quality assurance systems experience in a regulated industry such as Medical Devices or biologics (preferably in a small/start-up company).
  • 5+ years of experience as a Quality Manager/Quality leadership role in a regulated industry such as Medical Devices or biologics (preferably in a small/start-up company)
  • Must have a thorough knowledge of ISO, QSR and other relevant FDA requirements as applied to medical device development, manufacturing and quality including: cGMP, 21 CFR 820, QSR, ISO 13485, CMDR and the MDD.
  • Demonstrated experience hosting FDA, ISO and other regulatory audits and inspections is a must.
  • Thoroughly proficient with the regulations and best practices of cGMP compliance, both as an individual contributor and as a leader.
  • Proficient with and experienced with design control processes.
  • Proficient with validations – sterilization, packaging, particle monitoring, etc. (IQ, OQ, PQ).
  • Possess a quality-oriented approach to operations management and customer service with experience in operations, logistics, manufacturing related roles preferred.
  • Excellent oral and written communication skills with ability to effectively collaborate across various functional areas.
  • Proficient with Statistical analysis and the use of statistics to develop sample plans and trend analysis.

 

To apply:  https://www.indeedjobs.com/prosidyan-inc/_hl/en_US