Sirtex Medical is a global life sciences company with offices in the US, Australia, Germany and Singapore, working to improve outcomes in people with cancer. Our current lead product is a targeted radiation therapy for liver tumors 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.
The Quality Manager will be responsible for quality related activities and Quality team members located at current and future manufacturing facilities.
This is an on-site position based in the Woburn MA office and the employee will be required to work in the office on a regular basis.
- Lead and direct the efforts of the Quality team members to ensure that manufacturing related processes and activities comply with the applicable global medical device regulations (e.g. FDA, EU, etc.) and Sirtex Quality Management System
- Participate and deploy product or process changes throughout Sirtex manufacturing facilities, ensuring compliance to global medical device regulations and Sirtex Quality Management System requirements.
- Collaborates with other functional teams to identify, investigate and resolve product quality issues in a compliant and effective manner.
- Supports and participates in FDA, Notified Body and other audits
- Select, train, and develop staff as well as conduct performance reviews and performance management activities.
- Ensure complaint investigations are conducted in a timely manner and in accordance with medical device regulations and Sirtex Quality Management system
- Participate in supplier qualification, audit, ongoing monitoring, and supplier improvement activities.
- Develop and deploy Quality System related processes, tools, training, and metrics to enable Sirtex to meet business needs and comply and global medical device regulations
- Lead CAPA, post market surveillance and other quality improvement efforts across multiple sites
- Provide key quality trending information and data for use in periodic reviews
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).
Educational Prerequisites and Skill Requirements
- Minimum of 7 years Manufacturing Quality Engineering experience and 3+ years of leadership experience within Medical Device industry for companies with greater than $1bn USD annual revenue
- BS. in STEM (Science, Technology, Engineering, Mathematics)
- Demonstrable competency with the 21 CFR, 820, Medical Device Directive, EN ISO 13485, and EN ISO 14971, particularly with respect to Quality responsibilities associated with manufacturing related activities.
- Familiarity with the EU MDR regulation and Post Market Surveillance requirements
- Strong communication and presentation skills.
- Competent in Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).
- 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.
To apply, please email your cover letter and resume to Human Resources at firstname.lastname@example.org
Sirtex is an Equal Opportunity/Affirmative Action Employer including Disabled/Vets