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Quality Manager

2 weeks ago


Waterbury, Connecticut, United States UNIPHARM Full time

Job Summary

As a Quality Manager, you will play a pivotal role in ensuring that our products meet the highest standards of quality and compliance. You will lead the charge in implementing and maintaining quality management systems while adhering to industry regulations such as ISO 13485, FDA regulations, and CGMP. Your expertise will drive continuous improvement initiatives and foster a culture of quality throughout the organization.

What you'll do

  • Develop, implement, and maintain quality management systems in compliance with ISO 9001, ISO 13485, and other relevant standards.
  • Conduct thorough quality audits to assess compliance with internal policies and regulatory requirements.
  • Oversee quality control processes including inspections and testing to ensure products meet specifications.
  • Collaborate with manufacturing teams to identify areas for improvement and implement effective corrective actions.
  • Lead training sessions on quality assurance practices and regulatory requirements for team members.
  • Analyze data from quality inspections to identify trends and develop strategies for improvement.
  • Manage project timelines related to quality initiatives, ensuring timely completion of objectives.
  • Serve as the primary point of contact for external audits by regulatory bodies.

Basic qualifications

  • Strong understanding of ISO 13485, FDA regulations, HACCP (Hazard Analysis Critical Control Point), CGMP (Current Good Manufacturing Practice), and ISO 9001 standards.
  • Proven experience in quality management within a manufacturing environment.
  • Excellent analytical skills with a keen eye for detail in quality inspection processes.

Preferred qualifications

  • Experience leading quality audits and managing QA/QC processes.
  • Familiarity with project management principles and tools.
  • Strong communication skills to effectively collaborate across departments.

Why you'll love it here

We are dedicated to creating an environment where our employees can thrive both personally and professionally. We offer comprehensive benefits that support your overall well-being, ensuring you have the resources you need at every stage of your career.

Our benefits include:

  • Competitive pay structure
  • Comprehensive health benefits including medical, dental, and vision coverage
  • Retirement savings options to help secure your financial future
  • Opportunities for professional development and growth

About us

Join our dynamic team where innovation meets excellence We are committed to delivering high-quality products that enhance lives while fostering a culture that values collaboration, integrity, and continuous improvement. Together, we strive to make a meaningful impact in our industry while supporting each other along the way

Job Type: Full-time

Pay: $90, $100,000.00 per year

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Health insurance
  • Life insurance
  • Paid time off
  • Retirement plan
  • Vision insurance

Work Location: In person