QUALITY ENGINEER III

Resonetics•Montreal, QC

About The Position

This QE applies advanced Quality Engineering and scientific method techniques and principles to daily tasks and activities; applies relevant regulations, standards, and industry best practices to assignments; plans and conducts projects and assignments/activities with high technical responsibility, complexity or strategic input; Acts as a subject matter expert in routine Quality Engineering and scientific matters; receives occasional, summarized instructions from technical Quality leaders at various levels in addition to other functional stakeholders.

Requirements

Ability to create job-related documentation for quality purposes.
Familiarity with ISO 13485 standards and 21 CFR 820 regulations.
Minimum 2 years’ experience in a Quality Engineering role for a medical device manufacturer and/or start-up company, or equivalent engineering experience.
Demonstrated technical writing and communication skills.
Working knowledge of Statistical software and/or Minitab.
Bachelor’s degree or equivalent experience.
Interact with customer and supplier companies in a professional manner; proactively communicates with them to ensure an ongoing two-way exchange of information. Auditing and qualifications of new suppliers may be required.
Advanced level of oral and written French.
Advanced level of English, to interact with customers and suppliers who are mainly international. To comply with international industry standards.

Nice To Haves

CQE and/or Six Sigma Green or Black belt.
BS degree: Physics, Optics, Mechanical, Chemical, Plastics, Engineering
Strong attention to detail and satisfactory organizational skills.
Able to self-manage project tasks.

Responsibilities

Demonstrates high level of proficiency in applying various tools and methods to identify and realize new products or process introductions (ex. QMS, product related), and business improvements.
Leads and contributes to the application of, and/or develops innovative applications for various risk management and risk mitigation tools and practices.
Leads and/or contributes to root cause investigations using various problem-solving techniques and tools and assesses effectiveness of corrective actions.
Leads, conducts and supports the development of test methods in equipment, process, and product qualifications/validations.
Develops, implements, and/or maintains process Quality control plans are in accordance with product utilization and risk level and are followed.
Develops, reviews, implements and/or maintains process controls using appropriate techniques and tools (ex. Statistical process controls, statistical inspection sampling).
Support and ensure all levels of Design Controls per ISO 13485:2016 and QMSR 21 CFR 820 are being utilized, in addition to other product regulatory requirements.
Leads or participates in design/technical reviews as appropriate.
Interprets and implements standard and non-standard sampling plans.
Act as a subject matter expert (SME) in at least 2 routine Quality areas.
Partners with senior technical leaders (internal and external to the organization) to develop innovative approaches for identifying technical opportunities and quality improvements.
Mentors others in various technical capabilities.
Liaising with customer quality personnel to resolve issues and Customer Complaints.
Generating process deviations, Customer Change Notices, validation protocols & reports.
Assisting with troubleshooting of processes.
Assisting with production and product development processes.
Leading development of metrology equipment.
Developing and maintaining quality/control plans.
Ensuring Quality Management Systems procedures and appropriate regulations and industry standards are being utilized throughout the product development and process development processes.
Developing Risk documentation in compliance with the QMS and regulatory standards, such as PFMECAs.
Conducting Gage R&R studies
Resolving Corrective and Preventive Actions
Developing Quality Procedures and conducting training to all personnel as appropriate
Approving Nonconformance disposition
Analyzing production and validation data
Working on continual improvement and process assessment projects as assigned
Author protocols or provides support in performing qualification validation protocols in support of design control deliverables.
As a Quality Engineer on development projects, directly contribute and/or provide guidance to others to establish appropriate Design History File / Device Master Record documentation and provide detailed planning for product builds.
Support Equipment Calibration and Maintenance requirements per the applicable procedures.
To maximize the effectiveness of the position, this job description is subject to change according to a consensus of the 2 parties (Agile MV Technologies Inc «A Resonetics Company» and the employee).