Massachusetts Creative Jobs

Manager, Quality Assurance - Marlborough, MA

Marlborough, MA, United States

Job Summary: Join our dynamic team as a Quality Systems Manager, where you will be at the forefront of ensuring the effectiveness and compliance of our Quality Management System (QMS) with both US and international applicable regulations. This pivotal role involves close collaboration with cross-functional teams to maintain and enhance our quality systems. The ideal candidate will be a strategic thinker and creative problem solver with a proactive approach to quality management. Strong communication skills, attention to detail, and the ability to thrive in a fast-paced environment are essential.

Essential Duties and Responsibilities:

• Ensure compliance of the Surgical Division QMS with applicable US and international regulatory requirements and standards, including but not limited to 21 CFR Part 820, EU MDR, ISO 13485, and MDSAP.

• Develop, implement, and maintain comprehensive QMS procedures and work instructions.

• Oversee compliance of the CAPA and Non-conforming processes, acting as a subject matter expert.

• Identify corrective and preventive action opportunities through data analysis, including leading CAPA activities.

• Monitor and communicate quality systems Key Performance Indicators, escalating issues as needed.

• Oversee the Documentation Control Process and administration of document changes, ensuring compliance with regulatory requirements.

• Maintain and update Device Master Records (DMRs), Device History Records (DHRs), and other essential quality documents.

• Conduct regular reviews and updates of the QMS to reflect changes in regulatory requirements and industry best practices.

• Collaborate with R&D, Manufacturing, Regulatory Affairs, and other departments to ensure alignment of quality processes throughout the product lifecycle.

• Support internal and external audits, ensuring timely investigation and corrective action for non-conformances.

• Coordinate with cross-functional teams to ensure audit readiness and address non-conformities.

• Collaborate with Divisions and International teams to maintain integrity of the overall QMS.

• Provide quality-related support and guidance to cross-functional teams, fostering a culture of quality and continuous improvement.

• Develop and deliver training programs on QMS procedures and quality-related topics.

• Mentor and support quality team members, fostering professional growth and development.

• Plan and maintain departmental goals, supervise team members, manage performance, and ensure an engaging work environment.

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.

Experience:

• 5-8 years of progressive quality experience in the medical device or related industry.

• Minimum of 3 years of experience in quality management within the medical device industry, with a focus on women’s health.

• Experience with US and international regulations is essential.

• Minimum of 3 years supervisory experience preferred.

• Understanding and strong knowledge of applicable regulations and standards, particularly ISO 13485, 21 CFR Part 820, and EU Medical Device Regulation.

• Proven experience in root cause analysis tools and management of electronic document control systems.

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. 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’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.

#LI-LB2