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Doc Control Supervisor 3 CR

Regulatory & Quality Assurance
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Summary of Duties and Responsibilities:



·        Support Operational Excellence program and initiatives.

·        Maintain and control KPIs and other metrics.

·        Support local and extended CSPOs, VIP projects, improvement initiatives, NPIs, Product transfers, implementation of new technologies. 

·        Lead, develop, control and analyze best in class metrics and quality reports related to the implemented process, NPIs or product transfers. Establish appropriate results communication in accordance with the QS, Business strategic objectives and operational excellence. 


Resources administration:                                                                                                        

·        Innovate processes to improve efficiency and ensure compliance.                                            

·        Implementation of cost reduction projects that support business strategies.                           

·        Maintain, improve and simplify procedures, processes and methods.                                      

·        Prepare budget forecasts and ensure compliance with the approved budget.


Personnel administration                                                                                                          

·        Support and promote the implementation of EHS programs to ensure people safety and environment health.                                                                                                                   

·         Promote the execution of 1:1, open sessions, merit recognition, people motivation, effective hearing, assertive communication, feedback provision, appropriate environment, leadership.          - Ensure adequacy of the Regulatory training matrixes and verify that personnel is properly trained on time. Verify activities are executed in accordance with procedures and regulations.          - Develop, lead and facilitate to the collaborators the required tools, methodologies and materials to ensure completion of the organizational an individual objectives and operational excellence.                                                                                                                                

·        Promote creation and execution of Individual Development Plans (PDI). Coordinate and ensure that weekly payments are performed on time and in accordance with the assistance of each individual collaborator.                                                                                                      

·        Promote development of talented people and collaborators’ engagement.                                   

·        Record and communicate to the supervisor performance issues, disciplinary actions, performance evaluation in accordance with a world class company.                                          

·        Provide performance reports to the personnel as per the guidance provided by Human Resources. Feedback to improve performance should be provided to the personnel as required. 



·        Ensure participation in daily management meetings, coordinate priorization of daily activities based on business needs.

·        Coordinate review of production routers and sterilization records to ensure that QMS records are accurate and in compliance with the applicable acceptance criteria, regulations and international standards.

·        Coordinate finished goods release to the market as per the corresponding QMS requirements.

·        Escalate to the manager any non-conformance that may affect product quality or QMS compliance.

·        Provide guidance to CSPOs, inspectors, technicians, supervisors, engineers and others, about documentation accuracy requirements.

·        Maintain adequate communication channels and close relationships with key partners as Production, Planning, Shipping and Traffic to ensure Shipping Plan is met. 

·        Ensure response to the inquiries from sterilizers, distribution centers and distributors. 


Doc Control/Engineering Services

·        Review and facilitate change orders as ECOs, DCNs, SCOs, PCOs, etc., as per the corresponding QMS procedures.

·        Review that English and Spanish versions of documents match in terms of wording and contents.

·        Prioritize workloads for the team.

·        Provide guidance to CSPOs, supervisors, engineers and others, about the requirements of change orders.

·        Coordinate training to change orders creators.

·        Ensure accesses in the PLM system are provided to the users in a timely fashion. 

·        Maintain adequate communication channels and close relationships with key partners as Quality, CSPOs, NPI, Operations and other customers to ensure business needs are achieved.

·        Provide support to other Doc Control/Engineering Services department across Hologic.

·        Ensure Quality Records are storage and maintained in accordance with the QMS.

·        Ensure response on time to inquiries from customers and helpdesk tickets.




·        Personnel supervision

·        Teamwork

·        Planning and organization

·        Focused on goals

·        Decision making and problem solving

·        Leadership

·        Policies and procedures

·        Written and Oral communication

·        Customer service skills



·        University Bacherlor's degree in Business Administration, Engineering or related career.



·        Minimum 5 years of experience in positions of a similar nature.


Specialized Knowledge: 

·        ISO 13485, 21 CFR 820

·        PLM and Oracle Software

·        English (advanced)

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