Design Assurance Manager

General Overview

Summary

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 3 rd 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.

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 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

Knowledge/Skills/Competencies

• 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 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.

Typical Education

• Bachelor’s degree in Engineering or related field. Equivalent practical experience may be considered.
  Master’s degree preferred. CQE would be beneficial

Salary

The stated range includes Base Salary and target Short-Term Incentive (STI) compensation only. A comprehensive benefits package is offered in addition to this range.

The range described in this posting is an estimate by the Company, and may change based on several factors, including but not limited to a change in the duties covered by the job posting, or the credentials, experience or geographic jurisdiction of the successful candidate.

Range in US $107,272-$147,221

Notes

This job description is not intended to be an exhaustive list of all duties and responsibilities of the position. Employees are held accountable for all duties of the job. Job duties and the % of time identified for any function are subject to change at any time.