Vice President of Operations

Berlin, Connecticut, United States expand job description ↓

Description

  • Provide leadership and develop strategies around company’s activities
  • Work closely with all departmental teams (Manufacturing, Engineering, Supply Chain, Quality, HR, Finance, IT, and EH&S) to assure capacity is available for products and that new capacity/technology is sourced in support of growing demand for their new products/projects
  • Provide leadership and direction on new product development for the company and staff to assure that appropriate technology is available for product delivery and manufactured to meet all regulations
  • Demonstrate personal leadership while managing talent selection, development, training, succession planning, and performance management
  • Partner with team leaders in establishing systems that deliver competitive advantage, enable ongoing cost reduction, and concurrent business growth
  • Deliver strategic projects on aggressive timelines within budget and according to plan
  • Drive the Company’s Mission, Values, and Priorities initiatives, as well as the performance coaching process, to ensure a consistent high-performance culture
  • Ensure organization is FDA audit ready
  • Help prepare company and teams for updates to ISO requirements as they are rolled out
  • Support the development of operations related CAPA plans for issues of non-compliance
  • Track, measure and report the status of program milestones
  • Collaboration on the development of SOPs, Work Practice Guidelines, and associated tools
  • Periodically review SOPs, WPGs and related tools for applicability and suggest appropriate modifications



Requirements

  • Bachelor’s degree in Business or Engineering is required
  • Advanced degree, MBA, or MS Engineering, is preferred
  • Experience with ISO 13485 and FDA compliance programs
  • 15+ years of experience in medical device manufacturing disciplines
  • Demonstrated leadership and management experience working with cross-functional teams on complex projects
  • Experience in the development and production of specialized medical device products including developing and implementing new manufacturing processes
  • Ability to multi-task across a complex portfolio of products and processes
  • Experience in negotiating contracts with suppliers as well as ability to negotiate with regulators
  • Ability to problem solve and provide direction in complicated situations involving complex variables and incomplete information
  • Ensuring safe products, environment, and employees


Personal information
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Application Details
Do you have permanent residence status (greencard) or US Citizen as is required to work at an ITAR compliant facility?
Do you have experience with ISO 13485 and medical devices.
Are you will to report to work at 6:00 AM