Sirtex Medical Limited
Sr. Supplier Quality Engineer
Woburn, MA, us · Senior
Sponsorship not specified$98k-$123kDetected 21 days ago
ComplianceStakeholder ManagementAuditingProcurementFDA RegulatoryMedical DevicesCommunicationCollaborationProblem Solving
About the role
- Company Description Sirtex Medical is a global leader in healthcare, with offices in the U.S., Australia, Germany, and Singapore, dedicated to improving patient outcomes.
- By partnering with physicians, we aim to provide innovative products that enhance patient outcomes and simplify treatments.
- Achieving this ambitious goal requires passionate and talented individuals who are committed to making a difference.
Responsibilities
- Lead qualification, evaluation, and ongoing management of suppliers and contract manufacturers.
- Drive supplier corrective and preventive actions (SCAR/CAPA), ensuring timely and effective resolution of quality issues.
- Partner cross-functionally (R&D, Manufacturing, Regulatory, Procurement) to ensure supplier performance meets product and regulatory requirements.
- Monitor supplier KPIs and implement continuous improvement initiatives to enhance quality, delivery, and cost performance.
- Support new product introductions and technology transfers involving external suppliers.
- Demonstrated ability to work independently, lead initiatives, and drive measurable improvements.
Requirements
- Bachelor's degree in Engineering or related technical discipline required.
- Proven experience managing contract manufacturers and critical suppliers.
- Strong expertise in supplier auditing and regulatory compliance (ISO 13485, FDA QMSR, MDSAP).
Nice to have
- Experience with global regulatory environments and multi-site supply chains.
- Actual compensation may vary depending on the confirmed job-related skills and experience.
Compensation
- $98k-$123k
Benefits
- Sirtex recognizes that well-being, financial health, and work-life balance are crucial for our employees to achieve personal success.
- Ensure compliance with applicable medical device regulations and standards, including risk management (ISO 14971) and supplier controls.
- 5+ years of experience in supplier quality within the medical device or regulated industry required.
Company info
- An unwavering commitment to company values, employee safety and excellence in everything we do.
Equal opportunity
- All your information will be kept confidential according to EEO guidelines.
- Sirtex is An Equal Opportunity/Affirmative Action Employer.
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