Pentester performing numerous penetration tests on diverse environments for Mobeta startup. Engaging in R&D and collaborating with product teams to develop innovative solutions.
About the role
- Senior Staff Design Quality Engineer at Caris Life Sciences managing quality activities in design and development of medical products. Leading cross-functional teams ensuring compliance and risk management across projects.
Responsibilities
- Lead planning and execution of the new product development and design change projects with focus on Design Controls and Risk Management activities.
- Work effectively with cross-functional teams for the harmonization and consistency across several projects.
- Take ownership of the processes (Design Controls and Risk Management).
- Identify improvement opportunities, lead cross functional teams to implement the process improvements.
- Provide mentorship, guidance and training to the product development teams new.
- Support the implementation of eQMS tools for design controls and risk management (eDHF).
- Lead Design Reviews with participation from the core teams.
- Provide review and approvals of DHF deliverables such as verification and validation plan, protocol/report, requirements, and specifications.
- Lead creation of risk management file with support from the cross-functional product development teams, risk management plan/report, hazard analysis, dFMEA, uFMEA.
- Maintain risk file in the post market lifecycle phase.
- Support design transfer activities including BOM and DMR.
- Assist in regulatory inspection readiness activities and provide support during regulatory site inspections.
- Participate in process improvement initiatives as necessary, performing gap analysis.
- Perform root cause analysis, CAPA, closure of audit/inspection observations, and other QMS activities related to design controls and risk management.
Requirements
- Minimum 10+ years of hands-on experience, or relevant comparable background.
- Advanced understanding of the ISO 13485, FDA QSR/21 CFR Part 820, ISO 14971.
- Basic understanding of the IEC 62304, 62366 standards.
- Technical expertise and understanding of IVD assays and data analysis tools.
- Experience in successfully leading new product development teams through design controls and risk management processes, including DHF documentation including product risk file.
- Requires strong oral and written communication skills and interpersonal skills.
- Experience with IVDR, CAP/CLIA and GCP/GCLP preferred.
- Working knowledge of and proficiency in U.S. and International medical device regulations and implementing Quality Systems.
- Experience with mentoring junior people on the team.
- Adaptable to fast-paced, dynamic work environment with shifting demands.
Benefits
- Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions ) and reference verification.
- Employees may be required to lift routine office supplies and use standard office equipment.
- Ability to sit for extended periods of time.
- Most work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes, and bio-hazardous material in the lab environment.
- Travel may be required up to 15% of the time.
- Job may require after-hours response to emergency issues. At times may be required to work weekends/holidays.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Tech skills
Location requirements
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