Field Corrective Action Manager - Hologic
Newark, DE
About the Job
Field Corrective Action Manager
Newark, DE, United States
Join Our Growing Team at Hologic in Newark, DE!
At Hologic, our Innovation Center continues to expand, and we are thrilled to announce exciting new opportunities. We are currently seeking a dedicated and experienced Field Corrective Action Manager to join our Breast and Skeletal Health (BSH) Division.
What We Expect:
As the Field Corrective Action Manager, you will play a crucial role in preparing and overseeing field actions, collaborating closely with our Breast and Skeletal Health (BSH) division, as well as corporate and regional teams. Your expertise will be key in ensuring the comprehensive and timely development of Health Risk Assessments, Health Hazard Evaluations, Remedial Action Assessments, recall strategies, regulatory communications, and the execution and reconciliation of field actions.
In this role, your strategic vision and leadership will drive excellence in managing corrective actions, ensuring that our products meet the highest safety standards and regulatory requirements. You will be the linchpin in coordinating efforts across various teams, ensuring seamless communication and execution of critical field actions.
If you are ready to make a profound impact and be part of a forward-thinking, innovative team, we want to hear from you. Apply today and lead the charge in setting new benchmarks for quality and safety in the medical device industry!
What To Expect:
+ Management and coordination of the preparation and execution of field actions globally.
+ Schedule cross-functional meetings to develop plans, deliverables, and ownership for the various activities in support of Field Actions.
+ Coordinate with:
+ Divisional stakeholders the development of global recall strategies as well as regulator communications.
+ Hologic international QA/RA representatives to develop regional recall strategies and regulatory communications.
+ Collaborate with:
+ Design Assurance on development of Health Risk Assessments and Remedial Action Assessments.
+ Quality on processing Field Action records in Agile.
+ Marketing (with support from Legal, R&D, Quality and Regulatory) on the development of customer communications and Hologic field personnel FAQs.
+ Tracking the effectiveness of field actions including reconciliation of communications, corrections and/or removals.
+ Maintaining and attaching supporting records and documentation to Field Actions records.
+ Development and maintenance of the Field Action process and supporting work instructions.
+ Training personnel to the Field Action process.
+ Maintaining and reporting KPIs to management regarding the execution of Field Actions.
Qualifications:
+ Bachelor's degree with 5 - 8+ years of experience.
+ Experience with:
+ 21 CFR Part 7 Subpart C – Recalls (including Product Corrections), 21 CFR Part 806 Medical Device: Reports of Corrections and Removals, FDA Quality System Regulations, ISO 13485:2016 and EU Medical Device Regulation regarding field safety corrective actions.
+ FDA’s Industry Guidance for Recalls
+ FDA guidance on Distinguishing Medical Device Recalls from Medical Device Enhancements.
+ MEDDEV 2.12/1 Guidance on Market Surveillance – Guidelines on Medical Devices Vigilance System.
+ Multi source demands for project and product support, ability to coordinate and provide an effective team environment.
Skills
+ Ability to appropriately assess written product and project documentation as the principal advocate for compliance, and ability to effectively communicate assessment.
+ Ability to effectively direct managers, supervisors, and individual contributors of varying experience each with multiple products and projects to support.
+ Ability to determine when to take leadership role on critical tasks to assure appropriate and timely completion/resolution and when it is better suited to provide guidance to team.
+ Demonstrates independent decision making and prioritization, including independent resolution of conflicts.
So why join Hologic?
We are committed to making Hologic the company where top talent comes to grow. 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. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.
If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!
The annualized base salary range for this role is $101,300 - $168,800 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.
LI-#LL1
Newark, DE, United States
Join Our Growing Team at Hologic in Newark, DE!
At Hologic, our Innovation Center continues to expand, and we are thrilled to announce exciting new opportunities. We are currently seeking a dedicated and experienced Field Corrective Action Manager to join our Breast and Skeletal Health (BSH) Division.
What We Expect:
As the Field Corrective Action Manager, you will play a crucial role in preparing and overseeing field actions, collaborating closely with our Breast and Skeletal Health (BSH) division, as well as corporate and regional teams. Your expertise will be key in ensuring the comprehensive and timely development of Health Risk Assessments, Health Hazard Evaluations, Remedial Action Assessments, recall strategies, regulatory communications, and the execution and reconciliation of field actions.
In this role, your strategic vision and leadership will drive excellence in managing corrective actions, ensuring that our products meet the highest safety standards and regulatory requirements. You will be the linchpin in coordinating efforts across various teams, ensuring seamless communication and execution of critical field actions.
If you are ready to make a profound impact and be part of a forward-thinking, innovative team, we want to hear from you. Apply today and lead the charge in setting new benchmarks for quality and safety in the medical device industry!
What To Expect:
+ Management and coordination of the preparation and execution of field actions globally.
+ Schedule cross-functional meetings to develop plans, deliverables, and ownership for the various activities in support of Field Actions.
+ Coordinate with:
+ Divisional stakeholders the development of global recall strategies as well as regulator communications.
+ Hologic international QA/RA representatives to develop regional recall strategies and regulatory communications.
+ Collaborate with:
+ Design Assurance on development of Health Risk Assessments and Remedial Action Assessments.
+ Quality on processing Field Action records in Agile.
+ Marketing (with support from Legal, R&D, Quality and Regulatory) on the development of customer communications and Hologic field personnel FAQs.
+ Tracking the effectiveness of field actions including reconciliation of communications, corrections and/or removals.
+ Maintaining and attaching supporting records and documentation to Field Actions records.
+ Development and maintenance of the Field Action process and supporting work instructions.
+ Training personnel to the Field Action process.
+ Maintaining and reporting KPIs to management regarding the execution of Field Actions.
Qualifications:
+ Bachelor's degree with 5 - 8+ years of experience.
+ Experience with:
+ 21 CFR Part 7 Subpart C – Recalls (including Product Corrections), 21 CFR Part 806 Medical Device: Reports of Corrections and Removals, FDA Quality System Regulations, ISO 13485:2016 and EU Medical Device Regulation regarding field safety corrective actions.
+ FDA’s Industry Guidance for Recalls
+ FDA guidance on Distinguishing Medical Device Recalls from Medical Device Enhancements.
+ MEDDEV 2.12/1 Guidance on Market Surveillance – Guidelines on Medical Devices Vigilance System.
+ Multi source demands for project and product support, ability to coordinate and provide an effective team environment.
Skills
+ Ability to appropriately assess written product and project documentation as the principal advocate for compliance, and ability to effectively communicate assessment.
+ Ability to effectively direct managers, supervisors, and individual contributors of varying experience each with multiple products and projects to support.
+ Ability to determine when to take leadership role on critical tasks to assure appropriate and timely completion/resolution and when it is better suited to provide guidance to team.
+ Demonstrates independent decision making and prioritization, including independent resolution of conflicts.
So why join Hologic?
We are committed to making Hologic the company where top talent comes to grow. 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. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.
If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!
The annualized base salary range for this role is $101,300 - $168,800 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.
LI-#LL1
Source : Hologic
