USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.
As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?
Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.
This is a senior level position that is responsible for the quality oversight of design control and risk management activities for combination products and medical devices. This individual will work closely with the device development teams and medical device suppliers and testing partners during the device design/development phases with supportive responsibilities throughout the device lifecycle. In addition, this role will provide oversight for the development, implementation, and continuous improvement of device-related quality processes and procedures and ensure compliance to the relevant standards and regulatory requirements for devices and combination products.
Key components of the job function include:
• Mature experience in medical device/combination product design and development
• Lead Quality Engineering guidance and oversight for medical device and combination products during all phases of design control, risk management, human factor/usability engineering, process development and verification/validation testing, and potentially lifecycle management during design changes.
• Assist device development team to define critical to quality characteristics for device components and finished devices.
• Assist with Quality review and approval of technical documentation for design and development technical and risk management documentation, e.g., planning, traceability matrix, protocols, reports, risk assessments, testing, etc. through applying applicable company procedures and regulatory requirements.
• Escalate program and Quality concerns to Device Development Quality management.
• Provide input to process manufacturing design and design transfer to ensure compliant, robust product realization.
• Support the timely handling of investigations, impact assessment, deviations, and CAPAs, and technical matters (i.e. design changes, verification and validation) with impact to design control and risk management or related supply chain operations.
Specific qualities being looked for:
• Works very effectively (demonstrating open communication, input seeking, good listener, critical decision maker) in cross-functional team scenario.
• Delivering quality critical messages in a timely manner both horizontally and vertically.
• Sufficient experience to provide quality guidance and question approaches as appropriate to internal procedures and policy and regulatory expectations.
• Ability to work with minimal direction within project teams to attain group goals and key project milestones.
• Demonstrate effective cross-functional and cross-cultural skills.
• Ability to effectively influence others without direct authority and professionally handle conflict resolution
• Demonstrate ability to assess and provide technical and quality guidance to ensure high quality, compliant device and combination products.
• Demonstrate strong skills to organize, prioritize, and execute. Must be detail oriented with strong leadership skills and excellent interpersonal, collaboration and communication skills. Strong verbal and written communication skills
Technical Skills and Experience
• Experience in medical device design and development technical oversight and related risk assessment and management throughout the product lifecycle
• Quality oversight experience of device and/or combination product processes and documentation
• Working knowledge and application of device regulations, including 21 CFR 820, 2017/745, 21 CFR Part 4, ISO 13485, ISO 14971 and ICH Q9, ISO 11608, ISO 62366, ISO 10993.
• Experience in supplier management and relations, including quality agreement generation and maintenance.
• Working knowledge of process development and validation principles
• Experience in hazard analysis and application of risk analysis tools such as FMEA, Fishbone, etc.
• Experience with regulatory inspections and interaction with regulatory authorities
• Experience in Change Control
Minimum of a BS in Biomedical/Mechanical Engineering or related technical or scientific disciple. A minimum of 8-10 years of working experience in medical device and/or combination product function within a medical device, biotech, or pharmaceutical company
USDM Life Sciences is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Disclaimer: This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.