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Hologic - Marlborough, MA

posted 5 days ago

Full-time - Senior
Marlborough, MA
Computer and Electronic Product Manufacturing

About the position

Responsible for ensuring Hologic has robust and efficient systems to facilitate compliant and timely resolution of product and customer concerns; this includes maintenance, compliance, and continuous improvement of Complaint Handling and Post Market Surveillance, Medical Device Reporting, Medical Device Vigilance and Field Actions processes through collaboration with Divisional and International teams. Responsible to define, implement, maintain, and disseminate Key Performance Indicators, targets and provide visibility on the performance of these processes and product quality to senior leadership.

Responsibilities

  • Maintain the Corporate Complaint Handling, Post Market Surveillance, Medical Device Reporting, Medical Device Vigilance and Field Actions Procedures, work instructions and training material in accordance with all applicable internal requirements as well as all applicable regulatory requirements domestic and international.
  • Act as a Hologic subject matter expert for Complaint Handling, Post Market Surveillance, Medical Device Reporting, Medical Device Vigilance and Field Actions processes.
  • Interface with Service team to assure that processes are aligned for efficient data sharing, tracking, and analysis.
  • Perform assessments to identify gaps, plan and execute changes needed due to new or emerging regulatory changes.
  • Provide continuing liaison to IS functions to assure compliant, effective and adaptable Complaint Handling, Post Market Surveillance, Medical Device Reporting, Medical Device Vigilance and Field Actions platform performance.
  • Develop and implement highly effective strategies and processes related to Complaint Handling, Post Market Surveillance, Medical Device Reporting, Medical Device Vigilance and Field Actions processes and Metrics (KPIs).
  • Report to management on the performance of Complaint Handling, Post Market Surveillance, Medical Device Reporting, Medical Device Vigilance and Field Actions processes and any need for improvements.
  • Work to achieve the overall objectives related to the areas of responsibility and strategic goals and translate into tactical plans for effective implementation.
  • Develop rapid communication process between divisions, international, and service for timely flow of information and aligned actions.
  • Interact with senior management and collaborate across functions as needed to support company strategies and goals.
  • Assess process and system performance, identify and initiate actions to drive improvements.
  • Investigate, document and effectively implement NCEs, CAPAs and Internal Audit actions related to the compliance gaps within the process under responsibilities.
  • Work closely with other functions as needed (i.e. Service) to ensure appropriate process and inputs are defined and effectively implemented to support compliance to internal and external requirements and drive continuous improvement within areas of responsibilities.

Requirements

  • Bachelor's Degree in business, engineering, or science related discipline; or an equivalent combination of education and experience with a minimum of 10 years Medical Device Management Experience.
  • 10+ years progressive related quality assurance experience including proven managerial and project management skills.
  • Experience managing Post Market processes including Complaints, Vigilance, and Field Actions.
  • Experience in effectively completing internal and external audits successfully within an FDA regulated cGMP facility.
  • Proven track record of building and promoting a culture of Quality that has resulted in engaged employees and resulted in world class customer experiences.

Nice-to-haves

  • Demonstrated knowledge and understanding of regulatory requirements of the areas of responsibility.
  • Ability to be effective, collaborative leader influencing multiple stakeholders with varying processes and products.
  • Experience with electronic complaint filing and quality records requirements.
  • Excels in the use of quality data management tools for analysis leading to action.

Benefits

  • Comprehensive training upon joining and continued development and training throughout your career.
  • Annualized base salary range of $154,200 to $274,100, bonus eligible.
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