Operations Director

5 hours ago


Boulder, Colorado, United States Meddux Full time
Operations Manager Job Description

Meddux is seeking a highly skilled Operations Manager to join our team. As a key member of our leadership team, you will be responsible for leading and contributing to project teams, managing production planning and resource allocations, and supporting manufacturing assemblers and technicians.

Key Responsibilities:
  • Ensure compliance to ISO 13485 and 21 CFR 820 in manufacturing operations
  • Develop and implement assembly processes and product inspection or test processes
  • Manage and execute process validations and contribute to Risk Management efforts
  • Support New Product Introduction (NPI) and Design Transfer activities
  • Assist with build planning and inventory management
  • Ensure the accuracy and completeness of documents and records for inclusion in DHFs / DHRs
  • Collaborate on compliant and efficient strategies for reaching customer milestones
  • Participate in Material Review Board activities and provide disposition recommendations for nonconforming inventory
  • Lead root cause investigations and participate in the CAPA process
  • Track KPIs and report performance to senior leadership
Requirements:
  • Minimum 7 years of professional experience in medical device manufacturing
  • Strong understanding of ISO 13485 and 21 CFR 820
  • Excellent communication and leadership skills
  • Ability to work in a fast-paced environment and prioritize multiple tasks
  • Detail-oriented and organized with excellent record-keeping skills
  • Willingness to learn and grow within the organization
What We Offer:
  • Competitive salary range: $96,000 to $141,000
  • Bonus eligibility based on company performance targets
  • Comprehensive benefits package, including health, dental, and vision programs
  • 401(k) plan and 15 PTO days per year, with additional days for each year of service


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