Design Assurance Manager
Listed on 2026-01-20
-
Engineering
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Req
Region:
Americas
Country: USA
City:
Remote Employee US
The Design Services Quality Manager provides technical support to the Global Engineering Services Quality team in addressing the 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 delivering results on specific QA/RA projects, updating and improving the Quality Management System (QMS) and supporting Design Centers to ensure compliance to Standards and Regulations.
Additionally, support Design Centers with internal and 3rd party audits and in establishing and meeting goals and objectives. They will work across a wide variety of products and projects in the medical device, aerospace & defense, industrial, and smart energy sectors with team members around the world. Provides Global Quality oversight in administering Quality Management System and associated quality tools.
The Design Services Quality Manager provides technical support to the Global Engineering Services Quality team in addressing the 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 delivering results on specific QA/RA projects, updating and improving the Quality Management System (QMS) and supporting Design Centers to ensure compliance to Standards and Regulations.
Additionally, support Design Centers with internal and 3rd party audits and in establishing and meeting goals and objectives. They will work across a wide variety of products and projects in the medical device, aerospace & defense, industrial, and smart energy sectors with team members around the world. Provides Global Quality oversight in administering Quality Management System and associated quality tools.
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 delta 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
- 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.
- ISO 13485:2016 Lead Assessor certification preferred. CQA would be beneficial.
- Experience with 3rd Party Audits and FDA inspections as a SME.
- Excellent…
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