Quality Engineer

Job Opportunity: Remote Role in the Medical Device Industry

This remote position involves ensuring that products and services meet or exceed customer expectations and regulatory requirements, including those set by the FDA, Health Canada, and European MDD/MDR. The role includes participation in quality system processes related to complaint handling and supplier quality, along with providing engineering support in verification, validation, and problem-solving.

Responsibilities:

• Engage in continuous improvement activities and provide quality engineering support throughout the product lifecycle.
• Author, review, and approve Quality System documentation and Change Control.
• Drive supplier quality improvement and collaborate with suppliers to reduce defects.
• Conduct trend analysis and implement corrective/preventive actions to ensure product quality and compliance.
• Provide guidance on product development, improvement, and process enhancement projects.
• Plan, control, and assure product and process quality according to best practices.
• Maintain knowledge of relevant quality and regulatory standards.
• Participate in special projects as required.

Work Experience:

3+ years of engineering experience in the medical device industry, particularly in product development or quality engineering.

Preferred Education:

Bachelor's Degree in engineering, preferably electrical or mechanical. A Master's degree or ASQ Certification is a plus.

General Skills & Competencies:

• Experience in product, manufacturing, or quality engineering within the Medical Device Industry.
• Knowledge of LEAN and Six Sigma concepts.
• Strong verbal and written communication skills.
• Excellent problem-solving and decision-making skills.
• Ability to manage projects and understand financial impacts on business profitability.

Specific Knowledge & Skills:

• Strong understanding of medical device regulations and quality system standards.
• Experience in problem-solving methods and risk management implementation.
• Proficiency in product verification/validation and process validation.
• Experience in supplier quality and development.