Senior QC​/QA Technician

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. We're a fast-growing dynamic organization and we seek an experienced Senior Quality Control/Assurance Technician to help us with our growth.

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.

The position of Senior Quality Control/Assurance Technician is vital in assuring that only product meeting defined quality and regulatory standards leaves the manufacturing location. This position requires a detail oriented individual capable of working independently in a clean room environment and meeting the demands of production timelines and commitments. This position is responsible for:

• Ensure all activities are performed in accordance with Quality System requirements, work instructions and regulatory requirements.
• Support manufacturing by performing duties such as incoming, in-process, final inspections, DHR completion, Quality Control testing, product release, etc.
• Authorize release of approved material, intermediates and finished product
• Prevent release of suspect or known nonconforming products and materials
• Perform microbiological testing of environment and products as necessary
• Adhere to practices designed to protect both employees and product from contact and potential contamination, including suitable gowning and clean room practices
• Follow detailed process steps without deviation.
• Organize reports, files, and results in a professional proficient manner.
• Conduct training to Quality Systems processes as defined within the Sirtex learning management system.
• Be flexible and work within a small team without strictly defined roles to assure complete functional coverage

• Minimum of a High school degree
• Fluent in English (read, write and speak)
• Ability to learn and successfully execute tasks such as visual inspection and testing utilizing basic laboratory equipment
• 1-3 years' experience handling chemicals and using basic chemical laboratory equipment.
• 1-3 years' experience working in a medical device, pharmaceutical, or other regulated industry required.
• Personable, energetic, responsive and confident
• Strong organization and time management skills
• Self-starter with the ability to learn and work as part of a team.
• Strong verbal, written, analytical, persuasive skills and ability to interact effectively with all levels
• Strong interpersonal skills, energetic, proactive, flexible with high integrity and ethics in all dealings
• Basic office computer skills (email, word processing, and spreadsheet software)

• Undergo all formal Training Events as may be directed from time-to-time.
• Observe and comply with all Sirtex Corporate Policies.
• Work within, and ensure adherence to Quality System procedures, work instructions and other Quality System requirements.
• Work within, and ensure adherence to Health, Safety and Environment Management System…