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 team is 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 with strategic and operational plans.

As our Supplier Quality Engineer, you will provide support to the Global Supplier Quality organization dedicated to the oversight of suppliers. Your technical knowledge and expertise will enable you to across the organization to ensure suppliers can meet all requirements.

What To Expect

• Execute all applicable activities to comply with regulatory standards and meet the requirements established in the Quality Management System around supplier’s quality management.
• Conduct technical reviews on suppliers to understand their capability to make materials.
• Oversee, assess, and monitor suppliers making parts as it relates to manufacturing, process and quality control practices, corrective action, continuous improvement, and “First Article Inspection”.
• Define and approve PPAP (Production Part Approval Process) requirement for all new and revised purchased parts (as applicable). Follow up for their on-time completion.
• Work along with suppliers, to exceed the “fit, form and function” and reliability requirements, while working internally with Research & Development and Design Assurance.
• Issue and follow up on Agile Quality figures called “SCARs” and “SACAs” and “NCEs” related to suppliers providing components. Monitor timing of the workflows to comply with key performance indicators
• Work collaboratively with suppliers on problem solving and root cause analysis to avoid repeat failures. Apply (as applicable), metrology and statistical measurement to problem analysis and resolution.
• Work with Post Market Surveillance and other applicable departments (Quality Engineering, MFG Engineering, Research and Development, etc.) to address complaints linked to suppliers.
• Resolve quality day to day issues associated with suppliers around the globe by addressing non-conformities: call into containment and work along with the corresponding departments to achieve disposition of the impacted raw material (return to supplier, rework, sort, etc.). If applicable, collect and send back samples to suppliers if needed.
• Maintain complete supplier quality records as per the applicable procedure (e.g., supplier performance key indicators, supplier’s quality certifications, etc.). Update suppliers’ files when required and check that the information is accurate and complete, assuring that all applicable regulatory standards are met.
• Support audits as a subject matter expert.
• Update the ERP system with the status of the approved suppliers for the materials.
• As applicable, attend to functional and departmental meetings and follow up on action items accordingly.
• Coordinate/ execute the change in specifications and/or procedures when required through the corresponding change order.
• Generate supplier performance metrics to be used in decision making. Provide the necessary reports to the stakeholders.
• Coordinate Periodic Quality Review meetings with suppliers that require it, as well as follow up on the activities agreed upon in these meetings to ensure that they are carried out.
• Coordinate and execute activities related to the implementation of new suppliers as a result of the introduction of new products, transfer of products, alternate suppliers, etc.; ensuring that the component’s suppliers comply with the requirements stipulated in the quality system before the closure of the projects.
• Qualification of new suppliers and/or new parts/components of an already approved supplier.

What We Expect

• Expertise: Bachelor’s degree preferred in Bachelor related Engineering career.
• Knowledge: ASQ Supplier Quality Engineer Certificate, Project Management Techniques, FDA & ROW regulations
• Experience: Adhering to Medical Device Regulations, cGMP, CFR 820, ISO-13485, ISO-14971, ISO-9001
• Problem Solving: Ability to use problem-solving tools (SPC, TQM, etc.) to optimize processes. Ability to analyze a situation or data; evaluate relevant identifiable factors and translate this information into a meaningful proposal or action plan.
• Autonomy: Must be able to work independently and with all levels of the organization.
• Communication: Ability to effectively communicate ideas and approaches in the form of proposals, plans and presentations.
• Agility: Ability to handle and manage multiple complex projects. Flexibility to adapt to changing market conditions, requirements, and company priorities.
• Skills: Validations and root cause analysis, Proficiency with Agile.
• Collaborative: Works well with team members and internal teams globally
• 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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