Quality Assurance Manager

2 weeks ago


Warsaw, Indiana, United States Avalign Technologies Full time
Job Title: Quality Assurance Manager

Avalign Technologies is a leading manufacturer of innovative medical devices, and we're seeking a highly skilled Quality Assurance Manager to join our team. As a Quality Assurance Manager, you will be responsible for ensuring the quality and compliance of our products, as well as leading our quality team to achieve excellence in quality management.

Key Responsibilities:
  • Develop and implement quality management systems to ensure compliance with regulatory requirements and industry standards.
  • Lead and direct quality audits, internal and external, to ensure compliance with quality standards.
  • Manage the CAPA system, including initiation, investigation, and closure of non-conformities.
  • Assist in the coordination of continuous improvement processes for the quality system.
  • Develop and maintain quality procedures, work instructions, and training programs.
  • Collaborate with cross-functional teams to ensure quality and compliance throughout the product lifecycle.
Requirements:
  • Bachelor's degree in a technical field, such as engineering or quality assurance.
  • Minimum 8 years of experience in quality assurance or a related field, with a minimum of 3 years in a leadership role.
  • Proven experience in quality management systems, including ISO 13485 and FDA 21 CFR part 820.
  • Excellent communication and leadership skills, with the ability to motivate and develop a high-performing quality team.
  • Strong analytical and problem-solving skills, with the ability to identify and resolve quality issues.
What We Offer:
  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • A collaborative and dynamic work environment.
  • Recognition and rewards for outstanding performance.

Avalign Technologies is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and respectful work environment that values diversity and promotes equal opportunities for all employees.



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