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Job Description

QA Officer Supervisor

Region: Americas
Location: Wilmington, MA

Posted Date: 08/08/2022

Who We Are

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 QA Officer Supervisor to help us with our growth.

What You’ll Do

The QA Officer Supervisor is located at and supports the Wilmington, MA Sirtex Manufacturing facility. This role provides direct support to manufacturing activities and the working days align with the Wilmington SIR-sphere production schedule which is currently Saturday – Wednesday and subject to change. This role reports to the Quality Assurance Director and perform the following:

  • Support Wilmington, MA manufacturing by coordinating and supervising QA Officer activities.
  • Assist with scheduling of QA Officers to ensure adequate QA Officer support.
  • Participate in QA Officer interviews and support initial (and on-going) QA Officer training.
  • Provide input on QA Officer performance to the QA manager.
  • Perform duties such as incoming, in-process and final inspections, calibration, DHR completion, product release, etc.
  • Support Wilmington QA Officers through initial and ongoing training
  • Participate in discretionary projects such as development of QMS procedures, CAPA, process changes, supplier related activity, product development projects, etc.
  • Participate as QA Officer SME during internal and external audits of the Wilmington, MA facility
  • Authorize release of material, subassembly, and product.
  • Prevent release of suspect or known nonconforming product and materials.
  • Identify potential issues and escalate per QMS via CAPA, NCMR, Product Hold, etc.
  • Organize reports, files, and results in a professional proficient manner.
  • Comply with Sirtex QMS and applicable medical device regulations
  • Follow detailed process steps without deviation to assure a uniform output.
  • Complete all training as required
  • Observe and Comply with all Sirtex Corporate Policies

Who You’ll Be

  • High School degree or equivalent
  • 5 years working in the medical device, biotech, or pharmaceutical industries
  • Experience developing QMS procedures compliant to US/EU medical device regulations
  • SME experience in internal and external medical device/biotech/pharma industries audits
  • Experience handling chemicals and using basic chemical laboratory equipment
  • Proficient in MS Office

What to expect from Sirtex

If you have the right skills and experience and want to work for a company making a real difference to the quality of people’s lives, Sirtex will offer the right candidate:

  • Diverse and flexible employment and working arrangements to achieve the optimum balance between work and personal responsibilities and objectives.
  • A working culture of respect, diversity, and performance to help facilitate an inclusive culture.
  • Attractive compensation and benefit packages which are practical, robust, fair, and equitable.
  • A place to grow through career development and training opportunities.

Conditions of Employment

  • Sirtex Medical has implemented a mandatory vaccination policy effective November 1, 2021, requiring the COVID 19 vaccination for all employees. In accordance with Sirtex’s duty to provide and maintain a workplace that is free of known hazards, we are adopting this policy to safeguard the health of our employees and their families, and the community at large from infectious diseases that may be reduced by vaccinations.
  • Individuals seeking an exemption from this requirement for medical or religious reasons should complete a request for accommodation form and submit the form to the human resources department.
  • Sirtex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Sirtex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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. 

Apply Now!

Be part of an amazing team that is helping to save lives, every day!