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Manufacturing Quality Assurance Manager
Location: Woburn, MA
Posted Date: 06/30/2022
Who We Are
Sirtex Medical is a fast-growing, dynamic global healthcare company with offices in Boston, Germany, Singapore, and Sydney, each aligned and working to improve patient outcomes in people living with cancer. Our current lead product utilizes a targeted radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres. To date, patients with liver cancer across more than 1,300 medical centers in over fifty countries have collectively received over 100,000 doses of SIR-Spheres® Y-90 resin microspheres. Due to unprecedented growth and expansion, we are hiring a Manufacturing Quality Assurance Manager.
What You’ll Do
The Manufacturing Quality Assurance Manager is located at and supports the Wilmington, MA Sirtex Manufacturing facility. You will help to expand our product quality organization. You'll report to the Director of Quality Assurance and you will be accountable for:
- All Quality related activities, compliance to Sirtex QMS and applicable global regulations, and Quality team members located at the Wilmington, MA manufacturing facility.
- Leading and directing 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
- Leading internal and external audits of the Wilmington, MA manufacturing facility, follow up actions as required, and support audits of other Sirtex facilities
- Participating and deploying product or process changes at the Sirtex-Wilmington manufacturing facility, ensuring compliance to global medical device regulations and Sirtex Quality Management System requirements.
- Collaborating with other functional teams to identify, investigate and resolve product quality issues in a compliant and effective manner.
- Selecting, training, and developing staff as well as conduct performance reviews and performance management activities.
- Ensuring complaint investigations are conducted in a timely manner and in accordance with medical device regulations and Sirtex Quality Management system
- Participating in supplier qualification, audit, ongoing monitoring, and supplier improvement activities.
- Developing and deploying Quality System related processes, tools, training, and metrics to enable Sirtex to meet business needs and comply and global medical device regulations
- Leading CAPA, post market surveillance and other quality improvement efforts at the Sirtex-Wilmington site
- Providing key quality trending information and data for use in periodic reviews
- Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Using statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).
Who You’ll Be
To be successful in this role, we’ll require that you have:
- BS in Engineering or Science
- Minimum of 5 years Manufacturing Quality Engineering experience and 2+ years of supervisor or leadership experience within Medical Device industry for companies with greater than $1bn USD annual revenue
- 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
What To Expect at 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
Compensation and Benefits
Sirtex Medical has been named a best-in-class employer in the United States after scoring in the top quartile of large and midsize employers who participated in Gallagher’s 2021 Benefits Strategy & Benchmarking Survey. Sirtex was recognized as an organization that provides innovative solutions for creating organizational structures, workplace policies and total rewards, which inclusively engage and motivate its employees.
Gallagher’s Best-in-Class awards recognize employers that excel in supporting their employees’ physical, emotional, career and financial wellbeing for better organizational outcomes. “The HR team and I are passionate about creating a culture that cares about you and your family’s wellbeing,” said Sirtex Chief Human Resources Officer Cathleen Lowndes. “Our benefit program in the US is special and something I think we can all be proud of. While we still have opportunities to continue investing, we have made several noteworthy upgrades in the past few years.”
Recent upgrades to U.S. Benefits at Sirtex include:
- Implemented Flexible Work Policy
- Added domestic partner benefits
- Provide adoption assistance resources
- Upgraded our EAP program to provide you more mental health/wellness options
- Purchased a la carte hearing benefit
- Evolved our leave policies to be inclusive
- Added an additional medical plan to lower medical premium costs passed on to you
- Launched Own Your Career – $4000/per employee for professional development
“We take a proactive and structured approach to planning, developing and implementing comprehensive benefits and HR programs,” explained Cathleen. “We believe supporting our workforce builds our overall organizational strength and resilience. Without a doubt – we know that our people are the most important asset of Sirtex. “
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.
- Physical requirements include sitting, walking, standing for prolonged periods, possible radiation exposure.
- Willingness to:
- Participate in all relevant formal training events.
- Observe and comply with all Sirtex corporate policies.
- Work within, and ensure adherence to quality system procedures, work instructions, and other quality systems.
- Work within, and ensure adherence to health, safety, and environmental management system procedures, instructions, and other necessary factors.
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.
Be part of an amazing team that is helping to save lives, every day.