Global Process Owner, Quality Management Systems - Post Market Compliance from Joulé

Global Process Owner for Quality Management Systems
Lakewood, Colorado – Must be local hybrid 3 days onsite
Daily Schedule: 8am-5pm MST
Salary range target: $105-130k with 7% bonus

Key responsibilities / Must haves:

• Complaints handling process and revamping processes for complaints handling (global but mostly US regulations)
• Process improvement and business process improvement.
• Experienced across all device post-market compliance complaints and ISO 13485.

• Lead the strategic development and implementation of a robust Quality Management System (QMS) that aligns with regulatory requirements and organizational goals.
• Interpret and apply global regulations and standards, including FDA, ISO, EU MDR, and other relevant quality requirements for medical devices and combination products.
• Collaborate and influence global teams to drive alignment and best practices within the QMS framework.
• Manage and optimize electronic document management systems to ensure compliance and efficiency.
• Foster a culture of continuous improvement by challenging the status quo and implementing innovative solutions.
• Engage with stakeholders across all levels of the organization to promote open communication and collaborative problem-solving.
• Monitor industry trends and regulatory changes to ensure ongoing compliance and readiness.

• Education: Bachelor’s degree in a relevant engineering or scientific field.
• Experience: Minimum of 10 years in Quality, Regulatory Affairs, Manufacturing, or Engineering roles within regulated industries, specifically medical devices or pharmaceuticals.
• Expertise: Proven ability to interpret and apply global quality regulations and standards. Significant experience in a manufacturing environment is highly preferred.
• Skills:
  • In-depth knowledge of QMS frameworks and best practices.
  • Strong strategic thinking skills with the ability to maintain a globally standardized QMS.
  • Exceptional leadership, communication, and interpersonal skills.
  • Growth mindset with a focus on driving continuous improvement.
  • Ability to manage multiple projects and priorities effectively.
  • Proficient in relevant PC software applications, including PowerBI.