Quality Engineer III
A Quality Engineer III is responsible for quality planning and the overall quality of new products being released to the market. This role actively participates in product development activities, ensuring product and process conformance to global standards (including FDA and ISO 13485). The purpose of this position is to serve as a resource to product development and manufacturing to improve product quality, reliability, and process capability and facilitate teams in identifying, documenting, assessing, correcting and presenting quality issues using risk analysis and root cause analysis tools.
• Provide quality leadership to new product development teams in the areas of design control, design verification and validation, design transfer, process validation, risk management, and specification development
• Provide support to development, engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs and requirements.
• Collaborate with project teams to ensure understanding of and compliance with regulations, procedures, and requirements. Provide training, guidance and interpretation as needed.
• Ensure quality and completeness of project design history files, validation packages, and change orders
• Provide ongoing quality engineering support throughout the product life cycle, including CAPA investigations, and design changes.
• Enhance and drive product risk management activities. Ensure identified activities and mitigations are executed as agreed.
• Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making; coordinate issue resolution using a risk-based approach
• Review verification and validation reports and identify gaps for cGMP compliance. Develop and execute strategies to close gaps in an efficient, technical, and compliant manner.
• Provide consultation to end users and process owners with regard to data collection, analysis and creation of validation reports.
• Identify areas and opportunities to improve design and development process.
• Ensure product development and validation programs meet requirements of FDA and ISO
• Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis
• Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion.
• Review all product labeling to ensure it is accurate and consistent with the Risk Management system.
• Bachelor's degree in an engineering or science discipline; advanced degree preferred
• 5-10 years of experience in quality assurance in a regulated environment. Direct experience working with implantable devices preferred.
• Three - 5 years of experience applying quality regulations and standards (e.g. 21CFR 820, ISO 13485, ISO 14971, Medical Device Directive, etc.)
• Experience with CAPA and failure investigation tools and techniques.
• Applied experience with quality and statistical analysis tools (e.g. SPC, 6 Sigma, Risk Analysis, FMEA, DOE, trend analysis, etc.)
• Highly effective communicator, able to take action even when a position may be unpopular. Able to facilitate difficult conversations and negotiate solutions among different department representatives.
• Proven track record of strong team work and delivering results. Adaptable to fast-paced, dynamic work environment with shifting demands.
• Working knowledge of ERP Systems (SAP preferred) and Microsoft Office. Expert at Microsoft Excel.
• ASQ Certified Quality Engineer preferred.
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