Design Assurance Manager

Celestica is a leader in design and manufacturing solutions, partnering with top companies across various sectors. The Design Assurance Manager is responsible for managing and improving the Quality Management System (QMS) while providing technical support to ensure compliance with standards and regulations across multiple design centers.

Responsibilities:

• Responsible for Doc Control and Record Retention. Ensures that revisions to documents (procedures, documents and records) follow the requirements set forth by the QMS
• Responsible for ensuring standards used by the Design Centers are kept current and providing the deltas to the new standards
• Facilitate CAPAs (and NCRs) assigned to the Design Centers to ensure the CAPA process is followed and CAPAs (NCRs) are worked on in a timely manner
• Provide QMS coaching to the teams at the Engineering Services sites globally. Includes ensuring Trace matrices, Risk Management files and other project documents are correct and complete
• Support strategic development and improvements within the QMS
• Support Sales and Marketing with customer quotes/proposals. Ensuring that Quality requirements are covered in quotes/proposals
• Supports and facilitates Continuous Improvements to the QMS and Life Cycle/Design processes
• Supports Internal Audits as Lead Assessor or supporting auditor
• Supports 3rd Party Audits in the front/back room
• Creates slide deck for Management Review by gathering inputs from others as required
• Provide Training and Training governance on QMS
• Support Global Administration tasks: All Engineering/Design Center sites (currently 7: CTH, CSP, CPG, CMG, CNO, CSU, CRO) Implementing SOPs and WIs to support 9001 and AS9100 Standards in the QMS Manage CAPA, Record retention, Standards, Training, Support

Requirements:

• 7+ years' experience in regulated industry such as medical devices or aerospace
• Skills & Experience in the following areas: Design Analysis, Design Process, Design reviews, Engineering Change Management, Quality Data & Stat Analysis, Requirements Management, Risk Assessment
• Understanding of key Standards (ISO 13485:2016, ISO 14971:2019, AS9100D and ISO 9001:2015) and Regulations in support of projects for Health Tech, A&D and Commercial products
• Knowledgeable about Documentation Control and Record retention
• Experienced in RCCA methodologies and facilitating CAPAs
• Experience with 3rd Party Audits and FDA inspections as a SME
• Excellent understanding of intent for applicable Standards and Regulations
• Highly capable facilitator of Continuous Improvement projects as they relate to developing more effective and efficient processes and procedures
• 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
• Ability to establish goals and coordinate a wide variety of resources to meet quality and quantity metrics
• Ability to communicate effectively, both verbally and in writing, with a wide variety of internal and external customers
• Good verbal and written communication skills to effectively interact with users, SMEs, and other stakeholders
• Ability to explain Regulatory/Standards concepts to both technical and non-technical audiences
• Bachelor's degree in Engineering or related field. Equivalent practical experience may be considered
• ISO 13485:2016 Lead Assessor certification preferred
• Master's degree preferred
• CQA would be beneficial