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Job Description

Senior Quality Management System (QMS) Specialist

Region: Americas
Location: Woburn, MA or Remote

Posted Date: 11/14/2022

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 are a fast growing, dynamic organization.

Primary focus of this role will be to provide Quality System support in the execution of QMS activities associated with new and existing products and procedures to meet global medical device regulations.

*It is preferred for this role to be located at the Sirtex facility in Woburn, MA, however, US remote based is permissible with working hours being Eastern Time Zone (e.g., Boston, MA).

Responsibilities/Authorities

  • Serve as Quality System representative ensuring that QMS and compliance related activities are completed and comply with global medical device regulations (e.g., FDA, EU, etc.) and Sirtex Quality System requirements.
  • Serve as Sirtex’s CAPA Coordinator and Subject Matter Expert
  • Coordinate Sirtex’s complaint handling system, ensuring activities comply with global medical device regulations (e.g., FDA, EU, etc.) and Sirtex Quality System requirements.
  • Serve as an administrator within the Learning Management System for Quality Systems related training.
  • Coordinate and lead the generation of data and key quality trending information for use in periodic reviews like Quality Metric Reviews 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 to enabling Sirtex to meet business needs and comply and global medical device regulations
  • Complete all formal training events as directed by your manager
  • 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.

Educational Prerequisites and Skill Requirements

  • Minimum of 5 years Quality Assurance experience within Medical Device industry for companies with greater than $1bn USD annual revenue
  • Bachelor’s Degree
  • Demonstrable competency with the 21 CFR, 820, EN ISO 13485, and MDSAP.
  • Familiarity with the EU MDR regulation and Post Market Surveillance requirements
  • Strong communication and presentation skills.
  • Competent in Microsoft Office Suite.
  • Ability to prioritize, focus, collaborate, and work effectively in a fast paced and dynamic cross-functional environment


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.

What you can 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
  • Challenging work to continue to develop new and better ways to improve clinical outcomes for oncology treatment around the world

How to Apply

To apply, please email your cover letter and resumé to Human Resources at recruitment@sirtex.com

Sirtex is an Equal Opportunity/Affirmative Action Employer including Disabled/Vets