Responsible for ensuring Hologic has robust and efficient systems to facilitate compliant and timely resolution 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.

Essential Duties

Responsible to 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. Acts as a Hologic subject matter expert for Complaint Handling, Post Market Surveillance, Medical Device Reporting, Medical Device Vigilance and Field Actions processes. (CPO) Responsible for key interfaces with Service team to assure that processes are aligned for efficient data sharing, tracking, and analysis.   Responsible for performing assessments to identify gaps, plan and execute changes needed due to new or emerging regulatory changes. Provides 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. Responsible to 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). Reports to management on the performance Complaint Handling, Post Market Surveillance, Medical Device Reporting, Medical Device Vigilance and Field Actions processes process 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.  Responsible for developing rapid communication process between divisions, international, and service for timely flow of information and aligned actions.  Interacts with senior management and collaborates across functions as needed to support company strategies and goals. Assess process and system performance, identifies and initiates actions to drive improvements. Responsible for the investigation, documentation and effective implementation of NCEs, CAPAs and Internal Audit actions related to the compliance gaps within the process under responsibilities.  Works 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.

Qualifications

Education      

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.

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

Skills

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.

Why join Hologic?

We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is $154,200 to $274,100 and is bonus eligible.  Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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