Celestica · 15 hours ago
Design Assurance Manager
United States
Full-time
Remote
Mid, Senior Level
$107K/yr - $147K/yr
7+ years expCelestica 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.
ElectronicsManufacturingProduct DesignSupply Chain Management
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
Qualification
Required
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
Preferred
ISO 13485:2016 Lead Assessor certification preferred
Master's degree preferred
CQA would be beneficial
Benefits
A comprehensive benefits package is offered in addition to this range.
Company
Celestica
Celestica is a manufacturing firm that provides design, hardware platform, and supply chain solutions to a multitude of industries.
10001+ employees
H1B Sponsorship
Celestica has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (3)
2023 (6)
2020 (3)
Funding
Current Stage
Public CompanyTotal Funding
$1.47B2024-06-20Post Ipo Debt· $657.67M
2023-06-05Post Ipo Secondary· $148.8M
2021-09-30Post Ipo Debt· $660.4M
Leadership Team
Robert Mionis
President and CEO
Recent News
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2025-12-12
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