Description:

　　Own creation and implementation of all design control deliverables - Lead on-time Design Verification and Design Validation (and support Process Validation IQ/OQ/PQ/PPQ) planning & execution - Actively participate in and contribute to core team and customer facing meetings - Drive meaningful translation of User requirements into discrete, objective, measurable, verifiable, and traceable Product requirements - Oversee risk management activities throughout the device life cycle - from product concept through post launch - Create accurate and repeatable test & inspection methods - Support creation and execution of biocompatibility and sterilization qualifications - Analyze data and prepare product test reports - Oversee content of the Design History File, its completeness and integrity - Ensure component specifications are properly defined and evaluated through the creation of supplied component sampling plans, First Article Inspections, and supplier process qualifications - Support supplier management activities and external audits - Support external audit and certification efforts conducted by customers and regulatory bodies - Support manufacturing lines by resolving components issues or other manufacturing barriers in a timely manner. - Oversee and approve document change requests, non-conformances, deviations, and special work order processes - Lead root cause analysis and resolution activities - Review and approve equipment specifications and qualification activities - Develop/coach/mentor Design Quality Engineering TechniciansSkills:

　　Design control, Design assurance, Medical device, dfmea, Risk management, iso 13485, fda compliance, process validation, design verification, design validation, design for manufacturing, first article inspection, document changes, non conforming, root cause analysis, audit management, Process development, minitab

　　Top Skills Details:

　　Design control,Design assurance,Medical device,dfmea

　　Additional Skills & Qualifications:

　　Demonstrated use of quality tools and methodologies - Strong problem-solving proficiency - Ability to manage and prioritize multiple tasks and remain focused on personal objectives - High attention to detail and accuracy - Proven ability to work effectively independently and on a multi-disciplinary team - Good understanding of ISO 13485 and FDA QSR - ISO 13485 Lead Auditor training and certificationExperience Level:

　　Intermediate Level

　　Diversity, Equity & Inclusion

　　At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

　　Hiring diverse talent

　　Maintaining an inclusive environment through persistent self-reflection

　　Building a culture of care, engagement, and recognition with clear outcomes

　　Ensuring growth opportunities for our people

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.