Sr. Complaint and CAPA Specialist

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

The Sr. Complaint and CAPA Specialist is responsible for leading and executing complaint handling and corrective and preventive actions. As the subject matter expert, you will ensure compliant documentation and complaint handling and CAPA's to meet global requirements. Key skills required for this role are a deep understanding of medical device complaint handling requirements, strong analytical skills and excellent communication ability.

This role is located at the Sirtex Woburn facility with an expectation to work in Sirtex Wilmington when investigating complaints. Our current hybrid structure is 3 days/week in office and 2 days/week remote.

Responsibilities:

• Lead and Coordinate documenting, evaluating, assessing, and investigating feedback and complaints to meet regulatory requirements
• Maintainaccurate compliant entry of complaints while working with quality engineering and regulatory affairs to investigate and document complaints
• Ensure appropriate response and timely follow up to customer complaints including escalation, investigation and communication
• Prepare customer letters acknowledging receipt of the complaint, initiate return of product(s), outline the findings of our investigationand other appropriate follow up
• Develop and maintain a training program on complaint handling for a global organization
• Drive the complaints through resolution and closing, by gathering additional information as needed, working with cross-functional departments on proper investigations and ensure follow-up is completed and documented
• Escalate issues as needed, including trends in data through coordination and communication to the Complaint Board
• Track and ensure proper investigation, associated corrective/preventive action, as well as verification activities that stem from customer complaints, internal/external audit findings, failed product testing of any kind, deviations from policy and procedures or any adverse events
• Workwith and leadcross functional teams fromdocumentation of initial problem through investigation, root cause, impact assessment, implementation and verification of effectiveness (VoE)
• Coordination, communication and execution of CAPA board process

• Bachelors of Science in engineering, life sciences, quality, or other equivalent discipline required
• Medical Device experience required with additional pharmaceutical experience desired (ISO13485, FDA 21CFR820, EU MDR, MDSAP)
• 5 years experience managing customer complaints in medical device industry across US, EU, Asia, South America, Australia,
• Customer communication/ customer service experience

The target base salary range for this position will range from $96,000 to $121,000 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 10%for this position)and benefit plans, which include paid sick and vacation time, health insurance and a generous 401k matching program.

• 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 procedures, instructions and other requirements. 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 flexible work arrangements to achieve the optimum balance between work and personal responsibilities.
• A culture of respect, diversity, collaboration, and innovation fostering inclusiveness and superior performance.
• Attractive compensation and benefit packages which are practical, robust and equitable.
• A commitment to support ongoing professional growth through career development, on the job experiences and training opportunities.
• Challenging work which supports the development of new and better ways to improve clinical outcomes for oncology treatment around the world.
• An unwavering commitment to company values, employee safety and excellence in everything we do.

Diversity drives innovation; inclusion fosters belonging, growth and success. Sirtex believes that it takes multiple perspectives and voices to create a culture and workplace which fosters engagement, teamwork, and employee satisfaction to perform our best and deliver on commitments. We are dedicated to fostering an environment where all employees feel valued, included, and can share their ideas so that we can exceed even our own expectations.

Sirtex is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age or any other characteristic protected under applicable law. Sirtex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.