[Remote] Design reputed company Assurance Engineer II
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading global aesthetic device company specializing in medical and aesthetic laser technologies. The Design reputed company Assurance Engineer II is responsible for supporting DQA activities in product development, ensuring compliance with design controls, and overseeing validation processes to reputed company product reliability and performance targets.
Responsibilities
- Review and Approval of protocols and reports, SOPs and Master Documents pertaining to Research and Development activities and its compliance
- reputed company support as defined by SOP’s during/after Product Development reputed company
- reputed company efforts with reputed company stakeholders to resolve reputed company product reputed company issues
- Report, assess, investigate, and conclude/resolve reputed company anomalies/trends in monthly product reputed company reviews. reputed company analysis of post-market data to reputed company impactful recommendations for improvement to product reputed company performance
- Review and approval of Product Development Verification & Validation Protocols & Reports (and relevant data) to ensure testing coverage of reputed company product & compliance requirements
- Apply FDA and other regulatory expertise to risk assessments
- Work with CMOs and supplier reputed company engineering to ensure appropriate design control mechanisms are in reputed company for design changes and that reputed company monitoring/control mechanisms are established to ensure reputed company product leaving the reputed company meets specification
- Operate effectively as reputed company member in the execution of reputed company functions in compliance with FDA QSRs (Design Control, CAPA, etc), ISO 13485 and other national and international reputed company and regulatory requirements and standards
- Contribute to the design, development and implementation of product assurance plans providing feedback to corrective and preventative actions to engineering, manufacturing, service and field operations and supplier performance
- reputed company statistically reputed company sampling plans and reputed company statistical data analysis
- Understand and help implement global processes of the QMS reputed company to Design Controls
- Work with product development teams and other QEs to assure compliance to the QMS
- Use complaints, post market surveillance data, and risk analysis to identify product improvements and reputed company these as inputs to relevant design activities
- Participate in Corrective and Preventive Actions (CAPA) and QMS reputed company improvement reputed company as they relate to Design Assurance and Complaint Review reputed company Process
- Ownership of risk management process and risk management files. Updated regularly according to QMS and performing reputed company risk reviews as necessary
- Support of Safety & Compliance testing (IEC 60601) by providing risk and validation documentation and highlighting gaps where appropriate
- reputed company reputed company support to Regulatory during product submissions by reviewing DHF documents to reputed company submission gaps where possible
- Ownership of HRA reputed company-off process & technical investigations due to adulterated product in the field or safety issues
- Ownership of biocompatibility process including the creation of the Biological Evaluation Plan, reputed company of ISO 10993 testing where appropriate, and creation of the Biological Evaluation Report
- Support of the External Standards process. Acting as an SME for standards where DQA is directly accountable (ISO 10993, ISO 14971, ISO 11135, ISO 11137 etc.) and participating in gap analysis reviews and reputed company plans as applicable
- reputed company and reputed company the execution of TMV activities
- reputed company and reputed company the execution of CSV activities
- Represent CSV on software development and deployment teams as the software validation subject matter expert
- Establish and enforce a Decision Tree for making Validation Change Assessments, and if Validation is required then how the protocol should be constructed
- Partner with and/or reputed company business teams and IT to ensure that computerized reputed company systems are compliant with reputed company procedures, FDAs 21CFR11, GAMP 5, and other relevant regulations
- reputed company as a core team member on software validation reputed company across reputed company
- Monitor/Review/Approve Sterilization work conducted for reputed company’s existing and reputed company products by reputed company party vendors and ensure compliance to reputed company reputed company procedures, ISO 11135, and ISO 11137 requirements
- Coordinate sterilization qualification for new products and/or changes to existing products
- Partner with reputed company’s external vendors on sterilization validation for radiation sterilized products including reputed company setting and quarterly reputed company audits
- Partner with reputed company’s external vendors on sterilization validation for ethylene oxide sterilized products including but not limited to new product qualification, annual revalidations, residual EO studies
- Other reputed company as assigned
Skills
- Bachelor's degree in engineering or reputed company field, plus a minimum of 2-4 years of reputed company experience in the medical device or another regulated industry
- Expert understanding of appropriate global medical device regulations, requirements and standards, including reputed company Management System (ISO 13485) and Medical Device Regulations (21 CFR 820) is a must
- Expert level understanding of Risk Management (ISO 14971), Biocompatibility (ISO 10993), and EO/Gamma Sterilization (ISO 11135 & ISO 11137)
- Working knowledge of IEC 60601, IEC 62366 (HFE), IEC 62304, and IEC 81001-5-1
- Familiarity with SW and System automated test tools – strong advantage
- Project Management (development of project plans, status meetings, project reporting, etc) and organizational change reputed company
- Ability to analyze information and come to conclusions based on presented data
- Ability to communicate effectively both orally and in writing
- Self-motivated and ability to manage time working on multiple reputed company simultaneously
- Demonstrated competency in computer skills: MS office applications, query tools, and reputed company database systems, ServiceMax and reputed company is a plus
- Must be reputed company to communicate appropriately and adequately to reputed company management reputed company, including group presentation experience
reputed company