Position Summary

The Senior Manager of Quality will lead the Design Assurance and Post-Market Surveillance functions for cytology in vitro diagnostics, ensuring compliance with global regulations for new product development product design changes, and post-market surveillance (PMS). The Senior Quality Manager will also oversee complaint investigation, root cause analysis, and corrective and preventive actions to ensure timely resolution of quality issues and external failures. They are responsible for managing the risk management program and overseeing design assurance activities, including risk assessments, design changes, and new product development. They provide strategic direction, mentor the team, and drive product improvements to meet organizational and regulatory requirements.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs. 

Responsibilities:

Performance Management, Employee Development, and Cultural Leadership

Set and Oversee SMART Goals: Establish and manage SMART goals for the team to drive continuous improvement and align with organizational objectives. Employee Development and Training: Identify skill gaps and provide targeted training and development opportunities to enhance team capabilities, incorporate into SMART goals. Coaching and Mentorship: Provide guidance, support, and feedback to team members, fostering a collaborative and empowering environment. Drive Engagement and Foster a Quality Culture: Promote quality initiatives, integrate quality standards and standard work into all business aspects, and recognize contributions to quality improvements.

Quality Management System:

Management representative for the Cytology business for the Diagnostic division. Manage/host third party audits/inspections. Establish/maintain quality management system. Maintain ISO certificates. Manage relationship with notified body, ISO certificate issuing body, and any other regulatory compliance relationship. Lead and manage the design assurance team, ensuring compliance with regulatory standards (e.g., ISO 13485, 21 CFR Part 820) throughout the design control process.

Design Assurance:

Oversee the development, review, and approval of design inputs, design outputs, and design history files (DHF) for both new and existing products. Ensure comprehensive risk management activities, including the development and maintenance of risk management files (e.g., FMEAs) in accordance with ISO 14971. Direct the planning and review of design verification and validation activities, ensuring all requirements are met and properly documented. Provide strategic guidance and mentorship to design assurance engineers and other team members. Collaborate with cross-functional teams (R&D, Regulatory, Manufacturing, etc.) to ensure quality and regulatory compliance throughout the product development lifecycle.

Post-Market Surveillance:

Oversee the timely inflow and processing of customer complaints and adverse event reports, ensuring compliance with FDA 21 CFR, ISO 13485, IVDR, and FD&C Act requirements. Manage the product recall process, ensuring timely and effective communication, resolution, and compliance with regulatory requirements. Prepare and maintain detailed reports on recall activities and outcomes.  Ensure timely submission of Medical Device Reports (MDR) and Vigilance Reports to regulatory bodies and maintain thorough records of all reported incidents. Lead the preparation and submission of all required reports, including PSURs, PMS Reports, trend reports, FSCAs, incident reports, and SSPs, ensuring compliance with IVDR requirements. Analyze complaints to identify unacceptable trends and apply suitable corrective actions to reduce defects that meet established KPIs and objectives. Manage the investigation process related to complaint investigations to ensure identification of root causes for quality issues and implement effective corrective actions to prevent their recurrence.

Process Ownership:

Manage design and implementation of policies and procedures for design assurance, risk management, post market quality and related investigations.  Manage the Product Care Program to address emerging issues, drive continuous improvement initiatives to enhance product quality and patient safety. Oversee the preparation and reporting of quality data for Post Market Surveillance.

Reporting and Data Analysis:

Use data analysis to monitor trends, support quality initiatives, and ensure continuous product improvements. Ensure data presented in various forums such as management review, post market review etc. is compiled in a manner that drives discussions and action.

Professional Expectations and Standards:

Adhere to the FDA Quality Management System Regulation (QMSR), In-vitro Diagnostic Regulations (IVDR), Medical Device Single Audit Program (MDSAP), ISO 14971, and ISO 13485 standards in all tasks and responsibilities. Maintain rigorous attention to detail in documentation, reporting, and all product-related activities to ensure compliance and quality standards are met. Participate in regular training and stay updated on regulatory requirements, industry standards, and best practices. Demonstrate a strong commitment to the company's core values, including integrity, respect, collaboration, and innovation. Actively contribute to a positive and inclusive work environment, supporting colleagues and promoting a culture of mutual respect and teamwork. Engage in continuous improvement initiatives, striving for excellence and efficiency.

 

Qualifications

Minimum of 7-10 years of experience in post-market surveillance within the medical device industry. In-depth knowledge of FDA 21 CFR, ISO 13485, ISO 14971, MDSAP, and IVDR regulations. Proven experience in handling medical device complaints, adverse events, and regulatory reporting. Strong leadership and team management skills, with a track record of developing and coaching staff. Excellent analytical, problem-solving, and decision-making abilities. Strong communication and interpersonal skills, with the ability to work effectively in a cross-functional team environment. Proficiency in using quality management software and tools. Excellent working knowledge of Quality System Regulations (FDA), ISO 13485, ISO 14971, MDSAP, and IVDR.  Good knowledge of FD&C law. Strong working knowledge of all post market quality processes, IVDR, Field Actions and Analytics.

Education 

Bachelor’s degree in a scientific, engineering, or related field; advanced degree preferred.

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 as well as quarterly commission based on sales target. 

If you have the right skills and experience and want to join our team, apply today.

The total compensation range for this role is 132,100-220,200. This is based on a base salary and commission plan combination. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, territory/ geography, education, business needs, market demand and performance versus quota

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’s employees are subject to third-party COVID-19 vaccination requirements, including from customers and governmental entities. Hologic is an equal opportunity employer and consistent with federal, state, and local requirements, will consider requests for reasonable accommodation based on disability or sincerely-held religious beliefs where it is able to do so without undue hardship to the company.

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

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