Quality Specialist

Are you passionate about quality, compliance, and ensuring products reach customers safely and reliably? Do you enjoy working with logistics partners, solving problems, and driving continuous improvement? If so, we have an exciting opportunity for you to join our team as a Quality Specialist.

This is your chance to contribute to meaningful work in the medical device industry, where your expertise will help ensure our products are stored, handled, transported, and delivered in line with regulatory requirements, Good Distribution Practices, and Hologic’s quality standards.

As Quality Specialist, you will support the assessment, qualification, and ongoing management of Distribution Service Providers, including 3PLs, Logistics Service Providers, and Distributors. Your work will play a key role in maintaining product integrity, supporting compliance, and strengthening our distribution quality processes.

What to Expect:

• Assess, qualify, monitor, and requalify Distribution Service Providers in line with regulatory and Hologic requirements.
• Maintain lifecycle oversight, including assessments, quality agreements, audits, mitigation plans, corrective actions, and compliance documentation.
• Support DSP quality activities, including audits, validation, verification, and Quality System requirements.
• Collaborate with Regulatory Affairs and cross-functional teams to confirm local distribution requirements for storage, handling, transportation, traceability, and reporting.
• Investigate distribution-related non-conformances and complaints, including product damage and temperature excursions.
• Identify root causes and support corrective and preventive actions.
• Manage risks across the distribution network and support business continuity where required.
• Participate in change control activities related to DSPs, routes, packaging, and storage conditions.
• Maintain accurate non-conformance records, SOPs, inspection records, and validation documentation.
• Support metrics and KPIs to monitor DSP performance and escalate risks where appropriate.
• Identify opportunities to improve Quality System effectiveness in line with ISO 9001, ISO 13485, 21 CFR Parts 11 and 820, and GDP.
• Support internal and external audits and cross-functional projects as required.

What We Expect:

• Bachelor’s degree in Engineering, Quality Assurance, Supply Chain Management, Logistics, or a related field.
• 3+ years’ experience in medical device manufacturing or a related regulated industry, preferably within Quality.
• Knowledge of Good Distribution Practices, ISO 9001, ISO 13485, EU MDR/IVDR, and medical device regulations.
• Experience with root cause analysis, risk assessment, CAPA, and auditing.
• Experience with logistics and distribution processes is highly preferred.
• Strong communication and stakeholder management skills.
• Ability to work independently and collaboratively with internal and external partners.
• Good analytical, problem-solving, negotiation, and persuasion skills.
• Ability to produce clear reports and define practical action plans.
• Proficiency with Microsoft Office tools; Power BI and AI tools are a plus.
• Experience with PLM and ERP systems is preferred.
• Proactive, organized, adaptable, and able to manage multiple priorities.
• Strong ownership, accountability, integrity, and continuous improvement mindset.
• Customer-focused approach with a strong commitment to quality.

Why Hologic?

• Work on impactful projects that support product quality, compliance, and patient safety.
• Partner with internal teams and external providers to strengthen a reliable distribution network.
• Grow your career in a supportive, collaborative, and quality-driven environment.
• Competitive salary and benefits package, including health insurance.

Travel Requirements: 10% per year

Language Requirements: Proficient in English, written and oral. A second language is a plus.