Lead Engineer, Design Quality

General Overview

Job Title: Senior Lead Engineer, Design Quality
Functional Area:  Engineering (ENG)
Career Stream:  Design Quality Engineering
Role:  Senior Lead Engineer
Job Code:  ADV-ENG-DQE
Job Band: 09
Direct/Indirect Indicator:  Indirect

Summary

Your new challenge:

Take your next career step on by joining Celestica as Design Quality Engineer into a multinational company world leader in electronic manufacturing.

You challenge will be connected with the creation from conception, design, build and debug of new products and systems verification for different sectors: health-tech, aerospace and defense, smart energy and industry as our corporate design team is energizing the transformation of society and industry to achieve a more productive and sustainable future.

Your day- to-day activities will include…

You will be responsible for quality assurance of the design of the different products that our development teams bring to life; from architecture to electronic circuits design and analysis, verification, validation and transfer into manufacturing. The whole design lifecycle.

Detailed Description

Performs tasks such as, but not limited to, the following:

• Guide the quality assurance efforts in the design and development phase of new products in compliance with industry standards, regulations, guidance, and customer requirements
• Supervising quality design activities and review of any deviations
• Create/Review product risk management documentation (DFMEA, RMP, RMR, ...) in accordance with ISO 14971
• Conduct RCA and structured problem solving (CAPA)
• Support design reviews and transfers
• Compliance gap analysis
• Support design reviews and design transfers providing inputs on quality requirements
• Attend and support internal and external Design Audits
• Provide guidance and support to other engineers to ensure quality
• Create and maintain quality plans
• Support the creation of inspection criteria and risk mitigation strategies
• Liaison to regulatory agencies and supports product certifications (FDA, FAA, third party test houses, and CE marking bodies)
• Support QMS leader in maintaining QMS in compliance with 21 CFR820, ISO 13485, ISO 9001
• Collaborate with suppliers to drive compliance and quality improvements

Knowledge/Skills/Competencies

• Strong knowledge of quality management systems, industry standards (such as ISO 9001, ISO 13485), and regulatory requirements (such as FDA, MDR, RoHS, REACH).
• Proven experience on product development environment. specifically in the medical/healthcare arena. Solid understanding of electronic product development processes, including design controls, design verification, and validation.
• Experience with CAPAs handling, Non-conformance, Deviations, Complaints handling (Product Evaluations Reports, Notifications to Competent Authorities)
• Expertise in conducting risk assessments, failure analysis, and root cause investigations using tools and methodologies such as FMEA, DOE, and 8D.
• Knowledge of statistical analysis tools
• Experience in creating design control documentation during the whole lifecycle of the development process
• Experience with previous transfer of products from design to volume manufacturing
• Previous experience with PDM tools, product requirements and tracing
• Ability to work independently, prioritize tasks, and manage multiple projects simultaneously

Physical Demands

Duties of this position are performed in a normal office environment.

Duties may require extended periods of sitting and sustained visual concentration on a computer monitor or on numbers or other detailed data.  

Repetitive manual movements (e.g. , data entry, using a computer mouse, using a calculator, etc.) are frequently required.

Occasional travel may be required. 

Typical Experience

5 to 8 years

Typical Education

Bachelor degree minimum

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.