Head of Quality Management

2 weeks ago

Denver, Colorado, United States EPM Scientific Full time

Join EPM Scientific, a leader in the medical device sector, and contribute to our vision of transforming healthcare.

Key Responsibilities

  • Direct the strategic initiatives for design quality, risk assessment, and product lifecycle management within Research and Development.
  • Facilitate the integration of quality standards in new product initiatives and align with corporate goals.
  • Promote the use of product lifecycle management tools throughout the organization.
  • Optimize processes to enhance the effectiveness of a unified Quality System on a global scale.
  • Foster a robust quality culture within the business unit.
  • Enhance business systems to improve product quality oversight.
  • Work in close partnership with R&D to synchronize product quality strategies and governance.
  • Ensure adherence to Quality Management System standards (ISO 13485:2003, ISO 14971, MDD, CMDR, FDA).
  • Supervise design quality procedures to fulfill customer and regulatory expectations.
  • Collaborate with various departments to guarantee compliance with Quality System design controls.
  • Oversee internal and external audit processes and monitor corrective and preventive actions.
  • Regularly review quality assurance documentation to maintain regulatory compliance.
  • Implement comprehensive training programs to promote quality system awareness and adherence.
  • Track and report on Design Quality metrics to encourage ongoing improvement.
  • Develop an efficient departmental structure and manage the budget effectively.
  • Lead the recruitment, training, and performance assessment of team members.

Minimum Qualifications

Education

  • Technical degree with 10 years of relevant experience or a bachelor's degree with equivalent experience.
  • Preferred qualifications include a degree in electrical or mechanical engineering with a background in design engineering.

Experience

  • A minimum of 10 years in Quality/Quality Control, including 5 years in the medical device industry.
  • Experience in developing, managing, and auditing quality systems.
  • Involvement in complete medical device product development cycles.
  • Familiarity with various Quality activities and engagement with regulatory authorities.
  • Experience in supervisory roles and budget management within a dynamic corporate environment.
  • Desirable experience in start-up or small company settings, ISO certification, supplier quality management, and compliance with international standards.

Skills

  • Expertise in Design Controls Regulations and Quality practices in New Product Development.
  • Proficient in collaborative problem-solving with strict adherence to Quality Management System and external standards.
  • Ability to influence senior leadership and effectively coordinate cross-functional teams.
  • Demonstrates strong problem-solving capabilities and takes ownership of responsibilities.
  • Excellent communication skills with the ability to convey complex information clearly.
  • Proficient in Microsoft Office applications including Word, Excel, Access, and Visio.

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