Senior Manager, Device Quality Engineering
About The Position
Takeda Development Center Americas Inc.is seeking a Senior Manager, Device Quality Engineering with the following duties: Provide technical quality leadership and support for Takeda’s medical device and combination product development efforts throughout clinical development, design transfer, and commercialization; actively identify, lead, and drive implementation of Continuous Improvement (CI) projects in line with PSDQ goals, key business outcomes, and strategic plan; accountable for Device Quality functions in oversight of class 2 and 3 drug delivery devices and combination products or more complex holistic device programs (combination of multiple devices, apps, ancillaries); leads risk management and quality planning activities for assigned projects; collaborate with the cross-functional team to incorporate multiple inputs into the risk documents; be responsible to identify applicable regulations and standards and to ensure that assigned medical device and combination product development projects are in compliance to 21 CFR Parts 4 and 820, ISO 13485, ISO 14971, and other relevant global regulations and international standards; partner with Device Quality Assurance, Device Regulatory Affairs and Chemistry Manufacturing Control teams to provide technical quality support for regulatory filings; develop risk-based sampling strategies for design verification, design validation and inspection testing; act as subject matter expert for Device Development and Risk Management processes within their core teams; lead quality improvement initiatives and design improvements within lifecycle management of assigned medical devices or combination products; be responsible for quality assessment in due diligence activities and for supplier qualification including site readiness confirmation for assigned development projects; support internal and external audits including readiness as an SME on product design documentation and the design control and risk management SOPs; up to 10% domestic and international travel required; up to 60% remote work allowed.
Requirements
- Master’s degree in Engineering, Pharmaceutical Sciences, Life sciences or equivalent technical discipline or related field plus 6 years of related experience.
- Support the device product development within a medical device organization
- Be responsible for compliance with applicable corporate and divisional policies and procedures
- Provide overall quality engineering support for the client’s projects associated with medical devices belonging to Class II and Class III
- Utilize knowledge of both US and International Design Control and Risk Management requirements (specifically 21 CFR Part 820, ISO 13485, ISO 14971), as well as other applicable standards required, to provide technical quality leadership and support medical device and combination product development through clinical development, design transfer and commercialization
- Perform risk assessment activities and conduct Risk Analysis
Responsibilities
- Provide technical quality leadership and support for Takeda’s medical device and combination product development efforts throughout clinical development, design transfer, and commercialization
- Actively identify, lead, and drive implementation of Continuous Improvement (CI) projects in line with PSDQ goals, key business outcomes, and strategic plan
- Accountable for Device Quality functions in oversight of class 2 and 3 drug delivery devices and combination products or more complex holistic device programs (combination of multiple devices, apps, ancillaries)
- Leads risk management and quality planning activities for assigned projects
- Collaborate with the cross-functional team to incorporate multiple inputs into the risk documents
- Be responsible to identify applicable regulations and standards and to ensure that assigned medical device and combination product development projects are in compliance to 21 CFR Parts 4 and 820, ISO 13485, ISO 14971, and other relevant global regulations and international standards
- Partner with Device Quality Assurance, Device Regulatory Affairs and Chemistry Manufacturing Control teams to provide technical quality support for regulatory filings
- Develop risk-based sampling strategies for design verification, design validation and inspection testing
- Act as subject matter expert for Device Development and Risk Management processes within their core teams
- Lead quality improvement initiatives and design improvements within lifecycle management of assigned medical devices or combination products
- Be responsible for quality assessment in due diligence activities and for supplier qualification including site readiness confirmation for assigned development projects
- Support internal and external audits including readiness as an SME on product design documentation and the design control and risk management SOPs
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
5,001-10,000 employees
