Design Quality Engineer

Adecco is currently hiring for a Design Quality Engineer for our Medical Manufacturing Client in Ottawa West (Kanata). This is a contract opportunity for approximately 1 year. We are offering Full Time hours, Monday to Friday days. Compensation to be determined based on experience and education.

Design Quality Engineer Responsibilities:

 

Primary on-market quality assurance support for design control activities

Provide guidance and direction to a multi-disciplinary personnel involved in product development and production to arrive at solutions that support the company business objectives and quality standards

Able to define document requirements for products, process and test methods verifications and validations in accordance with FDA QSR’s and specific Design Control projects activities

Understanding of process, design and product/design verification/validation

Able to relate information to specification, product claims and design

Uses clinical knowledge, understanding of competitor’s products, and extrapolation from limited data to assure fitness for use

Responsible for implementation of design control policies and procedures

Contributes to the design, development and implementation of comprehensive product assurance plans providing feedback and corrective action for engineering, manufacturing, service and field operations and supplier’s performance

Liaises with project and program team members on technical and quality matters

Able to collect analyze and interpret data will be an integral part of the daily responsibilities

Able to utilize data to make driven decision and recommendations

Provide and/or participate in Design Control training

Responsible for review and approval of elements of Design Control including but not limited to: Planning, Device History File(s), Change Control and associated and supporting documentation

May have responsibilities for review and approval of DMF, DMR, MVP, and FMEA

Ensures that quality and compliance to site procedures are communicated and implemented

 

Design Quality Engineer Qualifications:

 

Bachelor in Science or Engineering

4 to 6 years of Quality Assurance experience in medical device manufacturing or pharmaceutical industries

Design Control Experience is required

Membership on the American Society of Quality Control (ASQ) or Society of Reliability Engineers is an asset

Good knowledge of quality regulations and standards, statistical calculation and measurement and manufacturing processes

Strong knowledge of inspection methods in design, fabrication and production of electronic equipment. Demonstrated skill in using test and measurement equipment. Working knowledge of GMP, ISO standards, FDA regulations, and Health Canada

Superior analytical and problem solving skills and statistical applications experience

Ability to be creative in achieving objectives while assuring compliance to internal and external requirements

Proven organizational and leadership skills. Ability to work under pressure in a fast paced environment

Excellent oral and written communication skills and ability to interact effectively with all levels in the organization

 

To be considered for the Design Quality Engineer in Ottawa, please Apply Now!

 
Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records