Job Details

Overview:
We are seeking an experienced quality professional to join our team and support critical product development activities. This role focuses on ensuring that design processes meet internal standards and regulatory expectations while contributing to risk management and continuous improvement throughout the product lifecycle. You will work closely with cross-functional teams to provide quality oversight during design and sustaining engineering efforts, helping to maintain compliance and deliver safe, effective products to market.

Key Responsibilities:

• Serve as a quality representative within development projects, providing input on design activities and documentation.
• Support design-related processes such as verification, validation, and design reviews to confirm compliance with requirements.
• Assist in evaluating design changes and ensuring appropriate documentation and traceability.
• Contribute to risk assessment and mitigation strategies during development and sustaining engineering phases.
• Maintain quality records and documentation to support regulatory submissions and audits.
• Collaborate with teams across engineering, operations, and regulatory functions to align on quality objectives and ensure consistent practices.
• Participate in continuous improvement initiatives to enhance design control processes and templates.

Qualifications:

• Bachelor's degree in engineering or a related technical field.
• Several years of experience in a regulated industry, ideally with exposure to product development and design processes.
• Familiarity with quality system requirements and design-related standards.
• Strong organizational skills, attention to detail, and ability to work independently in a fast-paced environment.

This position offers the opportunity to play a key role in supporting product development for innovative technologies while ensuring compliance and quality excellence. If you enjoy working in a collaborative environment and have experience with design processes and risk management, this role could be a great fit.