Director of Quality Assurance

2 weeks ago


Grand Rapids, Michigan, United States Skytron Full time
Director of Quality Job Description

At Skytron, we're committed to delivering innovative solutions that improve patient outcomes in the acute care market. As our Director of Quality, you'll play a critical role in ensuring our business operations meet the highest standards of quality and regulatory compliance.

Key Responsibilities:
  • Develop, implement, and audit Skytron's quality systems to support domestic and international sales and development activities.
  • Ensure compliance with applicable regulatory requirements, including ISO 13485, GMP, and FDA standards.
  • Foster a culture of quality excellence across the organization, driving continuous improvement initiatives to enhance our products and systems.
  • Manage internal investigations related to customer complaints and execute effective programs for CAPAS, field corrections, recalls, SCARs, and audits.
  • Monitor performance and feedback from customers, advising leadership on business implications of regulatory changes.
  • Lead training initiatives on quality standards and change management, directing the QA organization to ensure effective implementation.
  • Prepare quality-related product and process reports, analyzing data to inform business decisions.
Requirements:
  • Capable of handling administrative tasks with accuracy and efficiency.
  • Strong attention to detail, with the ability to multitask and meet deadlines.
  • Excellent communication and interpersonal skills, with a customer-centric approach.
  • Proven experience leading quality initiatives and teams in a highly regulated field, with a Bachelor's degree in a relevant field.
  • Direct experience working with FDA and other health authorities is highly preferred.
  • Knowledge of US cGMP regulations, industry best practices, EU MDD, and ISO 13485 requirements is highly preferred.
  • Proficiency in Microsoft Office, including Word, Excel, and PowerPoint.

We're an equal opportunity employer, committed to diversity and inclusion. If you're passionate about quality and regulatory compliance, and want to join a team that's dedicated to making a difference in the acute care market, we encourage you to apply.



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