Senior Quality Engineer

Responsibilities:

• Perform quality engineering activities supporting product development and cleanroom build operations.
• Ensure New Product Development (NPD) processes comply with quality systems and applicable regulatory standards.
• Update and maintain risk management and design control documentation.
• Develop and execute test method validations and qualification plans.
• Support design verification, process validation, and commercialization activities, including multi-site transfers.
• Collaborate with cross-functional teams including R&D, Manufacturing, Regulatory, Clinical, and Marketing.
• Maintain accurate and compliant quality documentation aligned with internal and external standards.
• Contribute to continuous improvement initiatives and quality assurance processes.
• Perform additional duties as assigned by leadership.

Qualifications:

• Bachelor s degree in Engineering or a Scientific field with 4+ years of experience, OR
• Master s degree (or equivalent) in Engineering or a Scientific field with 3+ years of experience.
• Strong understanding of engineering and quality principles, theories, and concepts.
• Experience in product development, quality assurance, or related fields.
• Knowledge of ISO 13485 standards.
• Experience maintaining risk management files and design control documentation.
• Strong analytical, problem-solving, and critical thinking skills.
• Excellent written and verbal communication skills with strong attention to detail.
• Ability to manage multiple priorities in a fast-paced environment.

Preferred Qualifications:

• Experience in medical device manufacturing or operations.
• Hands-on experience with test method development, validation, and fixture development.
• Basic understanding of statistical techniques and experience with tools such as Minitab.
• Ability to build strong cross-functional relationships and work collaboratively across teams.

Skills And Competencies:

• Strong organizational and documentation skills.
• Attention to detail with a focus on quality and compliance.
• Effective stakeholder communication and teamwork.
• Ability to handle competing priorities and deliver results under pressure.