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Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.

At Siemens Healthineers, we offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as Sr. Manager Quality Assurance.

Our global team: We are a team of more than 68,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.

Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers. 

This Senior Manager Quality Assurance (QA) position reports to the Director of Quality and supports cross functional operations at the East Walpole facility. The Senior Manager’s organization consists of Quality Professionals who provide daily support to the cross functional operations at the site across two business units which include Immunoassay and Point of Care. In addition to interacting with, and influencing the local manufacturing organizations, this position interacts with global Business Unit organizations such as Quality Systems, Commercial Product Quality, Regulatory Affairs, and Distribution. The primary responsibility is to ensure that an effective and compliant Quality System is implemented and maintained to support the manufacture and distribution of quality products to our customers.

This is a role well suited to an ambitious professional, looking for the next step in their career. As a Sr. Manager Quality Assurance, you will be responsible for:

  • Establish and maintain effective strategies and procedures in alignment with Global Procedures to ensure compliance with US and International standards applicable to In Vitro diagnostics. Such standards include; 21 CFR Part 820, 21 CFR Part 11, ISO 13485, and European IVDD Directive 98/79/EC.
  • Lead Quality Initiatives and identify and deploy resources to drive quality system improvements. Participate on global teams.
  • Direct a team of Quality Professionals who review and approve investigations and a separate team QA team that provides product disposition for the medical devices.
  • Foster trust, collaboration and cooperation with manufacturing teams when resolving discrepancies and non-conformance events.
  • Maintains metrics for Quality Notifications (Siemens term for deviations).
  • Review and Approve Quality Notifications, CAPAs, and other Quality Documents.
  • Provide resources to assist in the site’s internal audit program.
  • Conduct performance planning/review of staff and establish a vision and objectives for the group. Hire and develop Quality Professionals.
  • Ensure activities of the group are compliant with global procedures and applicable regulatory requirements.
  • Lead Backroom activities for regulatory and notified body inspections, e.g., ISO and FDA.

Required skills to have for the success of this role:

  • Requires a proven understanding of external regulations, particularly with regards to 21 CFR Part 820 and ISO 13485. Working knowledge of the IVDR Directive is highly desirable.
  • Experience: A minimum of 10 years of experience in either the medical device or pharmaceutical/biotech industry, with a minimum of 3 years in a quality leadership role.
  • Education: Bachelor’s degree in biology, chemistry, or another scientific discipline. Other educational experience will be considered in conjunction with work experience.
  • Strong oral and written communication skills and adept at establishing interpersonal relationships.
  • Proven ability to work in a team environment, balancing compliance risk with business need.
  • Previous experience approving deviations and CAPAs.
  • Proven ability to identify and implement improvements in manufacturing and quality processes that are efficient, sustainable and compliant, is preferred.

At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.

If you want to join us in transforming the way healthcare is delivered, visit our career site at https://jobs.siemens-healthineers.com/careers

If you wish to find out more about the specific division before applying, please visit: https://usa.healthcare.siemens.com/about.

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As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.

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Confirmed 19 hours ago. Posted 12 days ago.

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