Senior Quality Engineer

Responsibilities

• Provides quality leadership to new product development teams in the areas of design control, design verification and validation, design transfer, risk management, and specification development.
• Provides leadership to development, engineering and manufacturing functions for verification/validation planning and transfer activities.
• Affords assistance to teams in determining validation needs and requirements.
• Collaborates with project teams to ensure understanding of and compliance with regulations, procedures, and requirements.
• Offers training, guidance, and interpretation as needed.
• Ensures quality and completeness of design history files, validation packages, and change orders.
• Provides ongoing quality engineering support throughout the product life cycle, including CAPA investigations, and design changes.
• Drives product risk management activities. Ensures identified activities and mitigations are executed as agreed.
• Becomes familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making; coordinates issue resolution using a risk-based approach.
• Manages Quality Notifications (Non-Conforming Material Requests) system and disposes of all non-conforming product.
• Creates and maintains final inspection plans and collaborates with applicable subject matter experts to develop and validate inspection methods, as needed.
• Reviews verification and validation reports and identifies gaps for cGMP compliance.
• Develops and executes strategies to close gaps in an efficient, technical, and compliant manner.
• Provides expertise and guidance to end users and process owners with regard to data collection, analysis, and creation of design verification and validation reports.
• Safeguards all design history file contents meet the requirements of FDA and ISO.
• Trends and reports on quality data in order to improve product and process; develops recommendations based on data analysis.
• Provides management with status updates on assigned responsibilities and goals and escalates issues in a timely manner.

Qualifications

• Bachelor's degree in engineering or science discipline; advanced degree preferred.
• 5-8 years of experience in quality assurance in a regulated environment.
• Direct experience working with implantable devices preferred.
• 3 – 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.
• Knowledge of quality and statistical analysis tools (e.g. SPC, 6 Sigma, Risk Analysis, FMEA, DOE, trend analysis, etc.).
• Highly effective communicator. Able to facilitate difficult conversations and negotiate solutions among different department representatives.
• Proven track record of strong teamwork 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.
• Understanding of and experience with GD&T preferred.