Sirtex Medical is a global healthcare business with offices in Boston, Sydney, Germany, and Singapore, working to improve outcomes in people with cancer. Our current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres. More than 100,000 doses have been supplied to treat patients with liver cancer at more than 1,300 medical centers in over 50 countries. We’re a fast-growing dynamic organization and we seek an experienced Manufacturing Technician to help us with our growth.

At Sirtex, we’re transforming our industry through our leadership with interventional oncology and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. We offer stimulating careers and development, encourage innovation, and strive for excellence in everything we do. We will always foster a diverse and inclusive workplace, in which our global teams are united by an unwavering commitment to improve the quality and longevity of patients’ lives by providing innovative interventional oncology solutions.

Our facility in Wilmington, MA is responsible for the manufacturing of time sensitive high-energy beta radiation to support the treatment of inoperable liver tumors. We are looking for a high energy, self-motivated, team player, with a passion for making a difference to join our diverse team.

This position will support the Sirtex global Quality Management System (QMS) in the execution of QMS activities associated with all products and procedures to meet global medical device regulations and business needs.

This role will report to the Executive Vice President of Quality Assurance and be located at the Woburn, MA Sirtex facility or US remote with working hours within one hour of Woburn. Applicants should live in the Eastern and Central time zones.

• Primary responsibility is to perform all tasks associated with Document Control such as;
  • Maintain the Document Control System in accordance with compliance to Quality Management System, external standards, and regulations.
  • Execute the Document Control process in accordance with approved procedures and applicable global regulations.
  • Solicit input for improvement and lead continuous improvement activities to the Document Control system and procedures.
  • Maintain and update Document Registers, Master Lists and associated hard copy and electronic documents and data files
  • Register and process Document Change Requests and review, amend and issue associated documents
  • Accountable for timely processing of change requests in accordance with procedural requirements.
  • Identify, store, control and retain internal and external documents and electronic files in accordance with Quality System requirements
  • Withdraw obsolete and superseded documents from circulation and use and ensure appropriate disposal of documents requiring destruction, with due regard for security and confidentiality
  • Maintain formal filing (with suitable accessibility and retrieval) of current and archived hard copy documents and records
• Time permitting, perform additional QMS responsibilities such as;
  • Support QMS activities such as audits, CAPA, supplier monitoring, Management Review, training, etc.
  • Analyze QMS related data, develop and deliver charts/presentations for use in periodic reviews such as periodic Quality Metric Review and Management Review
  • Provide Quality functional support helping to achieve positive outcomes during audits (both internal and external)
  • Develop and deploy Quality System related processes, tools, training, and metrics enabling Sirtex to meet business needs and comply and global medical device regulations
• Complete timely Quality System training as assigned
• Comply with all Sirtex Corporate Policies, QMS, and applicable regulations

• Bachelor’s degree required
• Proficient in data analysis, PowerPoint slides and presentation skills
• Proficient in Microsoft Office suite software (Word, Excel, PowerPoint, Outlook)
• Excellent written and verbal communication
• Excellent organizational skills and attention to detail
• Ability to work independently and with others, multitask and coordinate activities across a range of functional areas
• Previous Document Control experience in the Medical Device or pharmaceutical industry preferred but not required
• Previous experience in the Medical Device or pharmaceutical industry preferred but not required
• Understanding of relevant requirements from regulatory and Quality Management System standards preferred but not required

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.