Quality Assurance Engineer

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.

Our mission is to be at the forefront of minimally invasive cancer and embolization therapies. 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. Our flagship product, SIR-Spheres® Y-90 resin microspheres, is a targeted radiation therapy for liver cancer. To date, we have delivered over >150K doses across 50+ countries, significantly impacting patients' lives worldwide. Our success is fueled by our dedication to serving the medical community, maintaining professionalism, fostering a collaborative work culture, nurturing an entrepreneurial spirit, and continuously pursuing innovation and improvement.

At Sirtex, we are committed to creating a great workplace. We offer a range of benefits, programs, and services to support our employees, ensuring they have opportunities to contribute to our success and advance their careers. Join our inclusive community, where you can collaborate with talented colleagues, bring your ideas to life, and advance your career, all while delivering innovative healthcare solutions to patients.

Job Description

This role will provide Quality Engineering support in the execution of manufacturing and risk management deliverables associated with new and existing products to meet global medical device regulations. The role also provides Quality Engineering support for complaint handling, design controls, and supplier related activities associated with new and existing products.

• Serve as Quality Engineering representative ensuring that design and manufacturing related activities are completed and comply with global medical device regulations (e.g., FDA, EU, etc.) and Sirtex Quality System requirements.
• Conduct risk assessments and implement risk management strategies to address potential quality issues throughout the product lifecycle.
• Support root cause analysis and corrective action processes for non-conformities, including the development and implementation of preventative measures.
• Generate and ensure compliant completion of Quality deliverables, including change requests, risk management deliverables, test methods, process validation, packaging and labeling documentation, standard operating procedures (SOPs), and manufacturing work instructions. Ensure all documentation is accurate and up-to-date.
• Assist with internal and external audits to assess the effectiveness of the quality management system and ensure compliance with regulatory and company standards.
• Provide key quality trending information and data for use in periodic reviews.
• Investigate customer complaints and analyze feedback to identify trends and drive improvements to product quality and customer satisfaction.
• Evaluate and monitor suppliers for quality performance. Collaborate with suppliers to address and resolve quality issues.

The target base salary range for this position will range from $85,000 to $99,000 annually. Individual compensation for this job requisition will be based on non-discriminatory factors, including your geographic location, skills, experience, education and other factors as they relate to the position requirements. Actual compensation may vary depending on the confirmed job-related skills and experience.

In addition to the expected base compensation, this role is eligible to participate in Sirtex’s incentive programs (target bonus of 5% for this position) and benefit plans, which include paid sick and vacation time, health insurance and a generous 401k matching program.

Qualifications

• BS in STEM (Science, Technology, Engineering, Mathematics)
• 3-5 years of Quality Engineering experience in the medical devices or pharmaceutical industry with demonstrated competency of 21 CFR 820, EU MDR, EN ISO 13485, and EN ISO 14971.
• Strong communication and presentation skills
• Competent in Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent)
• Ability to prioritize, focus, collaborate, and work effectively in a fast paced and dynamic cross functional environment

Additional Information

All your information will be kept confidential according to EEO guidelines.

Do you want to be part of something bigger? A team whose impact stretches across the globe making a real difference to the quality of people’s lives.  Sirtex recognizes that well-being, financial health, and work-life balance are crucial for our employees to achieve personal success. 

Sirtex offers qualified candidates:

• Diverse and