Product Quality Assurance Specialist

3 days ago


New Haven, Connecticut, United States PSG Global Solutions Careers Full time
Product Quality Engineer Job Description

We are seeking a highly skilled Product Quality Engineer to join our team at PSG Global Solutions Careers. As a Product Quality Engineer, you will be responsible for ensuring the quality of our pharmaceutical and medical products.

Key Responsibilities:
  • Develop and implement quality plans in line with regulatory requirements for combination products.
  • Provide quality oversight of design and development plans, user requirement specifications, and risk management plans.
  • Maintain product quality monographs, supply chain maps, and device master records in compliance with regulatory requirements.
  • Author global annual product quality reviews and coordinate with leads of contributing chapters.
  • Provide lead quality review of CMC sections of regulatory submissions and responses to queries.
  • Manage reference standard programs and ensure supply.
  • Facilitate product specification committees and global changes.
  • Support health authority inspections and compliance.
Requirements:
  • 10 years of cGMP experience within quality in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment.
  • Combination product and device delivery system experience.
  • Design for Six Sigma (DFSS) training and certification a plus.
  • Demonstrated ability in decision making, problem solving, and project management.
  • Excellent communication and interpersonal skills.
  • Proven record in demonstrating agility.
  • Flexibility to travel in support of the role.
  • Knowledge of process development and quality systems with a strong business and technical acumen.
Education:
  • B.Sc. degree in biological/chemical sciences, biomedical/mechanical engineering, or other related technical degree or equivalent experience in regulated industry.


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