Design Assurance Manager

Celestica International LP•Bothell, WA

1d•Remote

About The Position

The Design Services Quality Manager provides technical support to the Global Engineering Services Quality team in addressingthe essential and significant undertakings in the upkeep and continuous improvement of the Quality Management System(QMS) supporting our ATS design and engineering services organization. Responsible for planning, organizing, and deliveringresults on specific QA/RA projects, updating and improving the Quality Management System (QMS) and supporting DesignCenters to ensure compliance to Standards and Regulations. Additionally, support Design Centers with internal and 3 rd partyaudits and in establishing and meeting goals and objectives. They will work across a wide variety of products and projects inthe medical device, aerospace & defense, industrial, and smart energy sectors with team members around the world. ProvidesGlobal Quality oversight in administering Quality Management System and associated quality tools. Detailed Description 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 deltasto the new standards. Facilitate CAPAs (and NCRs) assigned to the Design Centers to ensure the CAPA process is followed andCAPAs (NCRs) are worked on in a timely manner. Provide QMS coaching to the teams at the Engineering Services sites globally. Includes ensuring Tracematrices, 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 arecovered 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.
Excellent understanding of intent for applicable Standards and Regulations.
Highly capable facilitator of Continuous Improvement projects as they relate to developing more effectiveand efficient processes and procedures.
Knowledge of an electronic manufacturing environment, materials, manufacturing and businessprocesses.
Ability to evaluate, prioritize and problem solve a variety of tasks to ensure their timely and accuratecompletion.
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 andexternal customers.
Good verbal and written communication skills to effectively interact with users, SMEs, and otherstakeholders.
Ability to explain Regulatory/Standards concepts to both technical and non-technicalaudiences.
Bachelor’s degree in Engineering or related field. Equivalent practical experience may be considered.

Nice To Haves

ISO 13485:2016 Lead Assessor certification preferred. CQA would be beneficial.
Experience with 3rd Party Audits and FDA inspections as a SME.
Master’s degree preferred. CQE would be beneficial

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 deltasto the new standards.
Facilitate CAPAs (and NCRs) assigned to the Design Centers to ensure the CAPA process is followed andCAPAs (NCRs) are worked on in a timely manner.
Provide QMS coaching to the teams at the Engineering Services sites globally.
Includes ensuring Tracematrices, 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 arecovered 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