The Regulatory Affairs / Quality Assurance will be responsible for the maintenance of Group K Diagnostics’ Quality Manual and Quality Management System, and will be tasked with determining, negotiating and securing buy-in on in-house quality procedures, standards and specifications. This person will assess customer requirements and ensure that these are met, while also specifying the quality requirements for raw materials with our suppliers. In collaboration with the Senior Director of Scientific Operations, this person will investigate and set standard for quality, health and safety, and ensure that manufacturing processes comply with said standards. This position will review documentation and final products prior to release.

In addition, this person will be responsible for:

  • planning, undertaking and overseeing product trials and regulatory inspections.
  • liaising and negotiating with regulatory authorities.
  • outlining requirements for labelling, storage and packaging.
  • ensuring that quality standards are met, and submissions meet strict deadlines.
  • establishing and enforcing quality standards.

This position will report directly to the Senior Director of Scientific Operations. This person should possess a keen attention to detail, strong communication skills – both verbal and written, be comfortable with data collection, management and analysis, and be adept at problem analysis and problem solving. This person should have strong planning, organization and decision-making skills, rooted in good judgement, and display a customer service orientation with the ability to work in a collaborative environment.

Requirements:

  • Must have a Bachelor’s degree in scientific field with 3+ years of experience
  • Preference will be given to candidates with certifications, including Quality Auditor, Quality Engineer, Quality Improvement Associate and / or Six Sigma
  • Must have experience in:
o quality inspection, auditing and testing experience
o implementation of corrective action programs
o relevant industries or products
o Microsoft Office, QA applications and databases
o quality control
o FDA submissions
  • Must possess a strong understanding of tools, concepts and methodologies of QA, as well as relevant regulatory requirements


17 days ago - source

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