As a leading innovator of women’s health, we at Hologic are empowering people to live healthier lives everywhere, every day.

Our quality and regulatory affairs teams are responsible for keeping abreast of new, changing and existing regulatory requirements. They lead the development and implementation of a global vision for regulatory affairs, government relations, quality management and market access, to influence strategic and operational plans.

As our QMS Specialist, you will work collaboratively with our Quality Commercial Operations Lead to maximize productivity. In this role, you will oversee tasks delegated to you, follow up on pending actions with the stakeholders and prepare reports for monitoring the progress of Quality Plans and other Quality Related Projects.

What to expect:

Compiling and analysing project data to report on project progress Attending project meetings and taking minutes Serves as QA interface to other departments and/or partners. Represents QA as a team member on cross-functional special project teams.  Developing databases for the projects deliverables Follow-up report and presentations preparation to ensure that deadlines are met Regular communication with stakeholders Assisting in QPL risk assessment activities Completing supplier creation administration, PO creation, change order creation, audit record creation, etc. Assist in developing and maintaining quality plans including change management methodology. Ensuring that processes and products comply with relevant industry standards, regulations, and legal requirements. Contributes to a culture of continuous improvement through process improvement activities. Assisting in external audits & regulatory body audits. Ensuring proper control and maintenance of quality-related documentation and records.

 

What we expect:

Expertise: Associate degree or bachelor’s degree, preferably in engineering/scientific discipline, biomechanical, biomedical, mechanical, electrical engineering Knowledge – Relevant work experience in the medical device industry Skill: Strong communication skills, with the ability to work in a fact paced environment   Autonomy: Demonstrates independent decision making and prioritization, including independent resolution of conflicts. Adaptability: Flexibility to adapt to changing market conditions, customer requirements, and company priorities. Experience: Project management or change management would be advantageous  Proactive: Ability to anticipate challenges and take initiative to address them. Resilience: Maintains a positive attitude and strong work ethic even in challenging situations.  Continuous Learning: A commitment to ongoing professional development and staying abreast of industry trends and advancements. Embraces and encourages learning new skills, knowledge and behaviors.

Why 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.

Our talent partners can discuss our salary offering and any relevant bonus schemes with you.

We look forward to hearing from you!

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