We are seeking a highly skilled and motivated Quality Systems Manager to join our team. The Quality Systems Manager will play a critical role in ensuring the effectiveness and compliance of our Quality Management System (QMS) with both US and international applicable regulations. This role involves working closely with notified bodies, regulatory agencies, and cross-functional teams to maintain and enhance our quality systems. The ideal candidate will possess strong strategic and creative problem-solving skills, be highly independent, have a proactive approach to quality management, excellent communication skills, attention to detail, and the ability to handle a fast-paced environment.

Key Responsibilities:

Ensure compliance of the Surgical Division Quality Management System with applicable US and international regulatory requirements and standards, including but not limited to 21 CFR Part 820, EU MDR, ISO 13485, MDSAP. Develop, implement, and maintain comprehensive QMS procedures and work instructions to ensure compliance with regulations. Conduct regular reviews and updates of the QMS to reflect changes in regulatory requirements and industry best practices. Collaborate with Divisions and International teams to maintain the integrity of the overall Quality Management systems, sharing best practices and implementing harmonized processes. Support communication with notified bodies and regulatory agencies during audits and inspections. Ensure appropriate gap assessments are conducted and applicable actions are implemented for emerging regulations and QMS changes. Maintain compliance of the QMS through integration or mergers, acquisitions, or scope expansion activities. Ensure appropriate preparation and execution when hosting internal and external audits. Identify opportunities for process improvements and drive implementation of creative solutions to enhance the efficiency and effectiveness of the QMS. Responsible for general compliance of the CAPA System and identifying corrective and preventive action opportunities. Oversee the management of quality documentation, ensuring accurate and timely record-keeping in compliance with regulatory requirements. Collaborate with R&D, Manufacturing, Regulatory Affairs, and other departments to ensure alignment and integration of quality processes throughout the product lifecycle. Develop and deliver training programs on QMS procedures, regulatory requirements, and quality-related topics. Mentor and support quality team members, fostering professional growth and development. Lead, coordinate, and supervise the team to balance workload and meet organizational goals.

Supervisory Responsibilities:

Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, training, and developing employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Required Qualifications:

Bachelor’s Degree in Life Sciences, Engineering, or a related field. 5-8 years of progressive quality experience in the Medical Device or related Industry. Minimum of [number] years of experience in quality management within the medical device industry, with a focus on women’s health. Minimum 3 years of supervisory experience preferred. In-depth understanding of FDA regulations, ISO 13485, EU MDR, and other applicable global standards. Proven experience in managing internal and external audits, including interactions with notified bodies and regulatory agencies.

Skills:

Excellent communication, organizational, and leadership skills. Strategic and creative problem-solving abilities. Highly independent, proactive, and self-motivated. Proficient in the use of product lifecycle management (PLM) tools. Proficient in the use of Microsoft Office Suite.

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 102,000-171,500. 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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