Senior Lead Engineer, Design Quality

Detailed Description

Performs tasks such as, but not limited to, the following:

• Develop new or significantly modify and improve Quality Management Systems.
• Facilitates input for improvement and training of teams.
• Participates in QMS planning and scheduling.
• Actively participates in design reviews and design transfers providing inputs on quality and requirements.
• Develops Design Controls in compliance with 21 CFR 820, ISO 13485, AS9100 and ISO 9001.
• Provide leadership and direction for internal and external Design Audits.
• Works with extended teams to address findings and close actions.
• Offers technical advice and feedback to the customers’ technical staff regarding customer/regulatory audits.
• Provide guidance and support to other engineers, sharing best practices and fostering a culture of quality.
• Ensures project deliverables from engineering teams are compliant with the appropriate standards.
• Review and ensure suppliers are in compliance with quality standards and specifications.
• Liaison to regulatory agencies and supports product certifications.
• Support the submissions to FDA and CE Marking (EU MDR)
• Create, update and review product risk management documents (Hazard analysis, DFMEA, RMP, RMR) in accordance with ISO 14971.

Knowledge/Skills/Competencies

• Project Management - Ability to manage/lead complex, multiple line engineering projects that may also involve other functions.
• Leadership - Demonstrate "People & Team Leadership Behaviors" as per Celestica Leadership Imperatives.
• Financial Acumen / Business Planning - Ability to create financial plans for your projects, align them internally with your line of management and other functions and externally if needed.
• Technical Skills - CAPA/RCCA/CI: Basic understanding, Design Analysis, Design Process, Design Reviews, DFMEA, Engineering Change Management, Industry & Reg, Quality Auditing, Quality Data & Stat Analysis, REQ Management, Risk Assessment, Technical Writing.

Additional Knowledge, Skills And Competencies

• Knowledge of an electronic manufacturing environment, materials, manufacturing and business processes.
• Ability to evaluate, prioritize and problem solve a variety of tasks to ensure their timely and accurate completion.
• Fair understanding of quality management systems and processes, including ISO9001, TL9001, AS9100, ISO13485, ISO14001, ANSI/ESD 20/20.

Technical Skills

• CAPA/RCCA/CI: Basic understanding
• Design Analysis
• Design Process
• Design Reviews
• DFMEA
• Engineering Change Management
• Industry & Reg
• Quality Auditing
• Quality Data & Stat Analysis
• REQ Management
• Risk Assessment
• Technical Writing