Staff Quality Engineer

Requirements

• Leads initiatives that change how quality is executed across multiples BUs or sites
• Establishes standards, frameworks, or methodologies adopted beyond local teams
• Serves as escalation owner for high impact product quality & compliance risks
• Leadership of critical product, process investigations and audits.
• Identification, execution and advise on strategic quality projects with company wide impact.
• Ownership of quality investigations for complaints and non-conformances.
• Author, review, and approve QA documentation, protocols
• Leadership of critical CAPAs
• Serves as subject matter expert in critical audits.
• Analyze and interpret advanced quality data and KPI trends.
• Mentor junior and senior engineers in technical expertise.
• Ensure compliance with company and regulatory standards (GMP, ISO, FDA). Provides industry expertise.
• Advise cross-functional teams on quality requirements.
• Identification and ownership of continuous improvement projects.
• Design Control and Risk Management Stewardship: Planning and execution of design controls, risk management, and design verification/validation for new products
• Advocate product design history file and ensure compliance with internal processes and external standards and regulations.
• Understand user needs and assure they are translated to the design, while ensuring compliance with usability and human factors standards and regulations.
• Partner with engineering to define design inputs, design outputs, and traceability matrices.
• Contribute to the strategy and execution of risk-based design verification and validation.
• Accountable for overall risk management file: participate and support the development of product risk management file, to analyze and assess the product risks associated with user, design, process and supplier.
• Support design controls activities associated with new product development. Advocate and ensure the transfer of reliable and scalable designs to manufacturing
• Review and provide feedback on design architecture, selections, requirements, and drawings from early design.
• Collaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate transfer of scalable designs into production.

Benefits

• Market-competitive compensation packages
• Inclusive of base pay, incentives, benefits, and equity
• 401k Matching