Job Description

Overview

We are seeking an experienced and detail-oriented Quality Engineer to join our team. The ideal candidate will play a crucial role in ensuring that our products meet the highest quality standards throughout the Medical Device (ISO 13485) and Aerospace (AS9100) manufacturing processes. This position involves collaborating with various departments to implement quality assurance protocols, conduct inspections, and drive continuous improvement initiatives.

Duties

Creating Quality Control Plans for products and processes, including considerations for material testing, process validation, risk analysis, and dimensional inspection Developing and implementing manufacturing process validation plans, and providing Quality support to bring new processes and equipment in-house. Leading and facilitating external audits, and maintaining dialogue with Health Canada, FDA, and other regulatory bodies. Supervising Quality Staff including Quality Inspectors and Quality Engineers. Managing Inspection Lab activities. Planning and managing testing activities, evaluating test data and interpreting results, communicating actions and outcomes of testing activities, preparing reports by collecting, analyzing, and summarizing data. Identifying and documenting quality issues in Nonconformance Reports, performing root cause analysis, implementing Corrective and Preventative Actions (CAPA), and dispositioning nonconforming product as required. Performing supplier qualification (including second party audits) and maintaining Critical Supplier List. Participating in manufacturing risk analysis and process design reviews. Leading continuous improvement activities for the Quality Management System (QMS) by implementing revised procedures and documentation. Overseeing general information systems used within the QMS. Providing quality engineering support to internal and customer projects as assigned.

Requirements

Bachelor's degree in Engineering or a related field. Proven experience in manufacturing, quality control, or quality assurance roles. Strong analysis skills with the ability to interpret complex data sets effectively. Familiarity with quality inspection techniques and methodologies. Knowledgeable in Quality Management Systems and their implementation in accordance with standards (ex. ISO 13485, ISO 9001, AS9100). Understanding of good manufacturing practices and documentation. Capable of reading and interpreting technical drawings. Familiarity with various inspection methods and processes. Formal training in Geometric Dimensioning and Tolerancing (GD&T) is an asset. Knowledgeable in Health Canada and FDA regulations is an asset. Minimum 3 Years in Quality Engineering or Quality Lead positions in a Manufacturing environment (medical devices, aerospace, defense or any other regulated industries).

Skills

Knowledgeable in problem-solving and quality improvement tools and techniques. Understanding of statistical tools. High attention to detail and the ability to work in a team environment are essential. Strong analytical, and communication skills. Experience in project management is highly desirable. Excellent communication skills, both written and verbal, with the ability to work collaboratively in a team environment. Detail-oriented mindset with a commitment to producing high-quality work. Good planning and project management skills. Self-driven, and able to make decisions. Proficient in Microsoft Office and Minitab (or similar).

Other

Candidate will require an RCMP background check and must meet the requirements of the Canadian Controlled Goods Program. Eligible for Professional (EIT or P. Eng.) Registration with Engineers Geoscientists Manitoba (EGM)
Job Type: Full-time

Pay: $52,000.00-$92,000.00 per year

Benefits:

Casual dress Company events Dental care Extended health care Life insurance Mileage reimbursement On-site parking Paid time off Vision care
Experience:

QA/QC: 3 years (preferred)
Work Location: In person