Quality Engineer II - Exempt

Join our dynamic team and contribute to the future of Robotic Surgical Technologies from the comfort of your own home in Virtual, FL. We are seeking a highly skilled professional to manage quality assurance systems and drive continuous improvement in our supplier quality engineering processes.

Must Have:

• Bachelor’s degree in mechanical/production engineering with 9–12 years of relevant experience.
• Strong expertise in DFM&A principles and manufacturing methods for plastics, metals, and packaging components & systems.
• Proven experience in analyzing project feasibility for cost savings and efficiency improvements.
• Proficiency in CAD - Creo/SW and PLM/PDM tools (preferably Windchill).
• Solid understanding of project management methodologies, including planning, tracking, and cross-functional collaboration.
• Strong verbal & presentation skills for effective collaboration with global teams.
• Well versed with MS PowerPoint and Excel for reports preparation, data analysis/advanced operations.
• Proficient in conducting Production Part Approval Process (PPAP) to ensure compliance with technical specifications and quality standards.
• Skilled in performing detailed Root Cause Analysis to identify issues, implement corrective actions, and drive continuous improvement.

Top 3 Technical Skills Required:

• Lead, support, review, and approve supplier change requests (SCR), Validation, TMV, PPAP, SCAPA, QMS, etc.
• Work with new and existing clients/suppliers to develop, implement, and maintain technical quality assurance systems and activities including Quality Plans, Control Plans, and FMEAs.
• Familiar with the Medical industry requirements such as ISO 13485, 21 CFR 820 standards, etc.

Responsibilities:

Responsibilities may include the following and other duties may be assigned:

• Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished materials product.
• Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
• Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control, and/or research and development as they apply to product or process quality.

Required Knowledge and Experience:

• Requires practical knowledge and demonstrated competence within the job area typically obtained through advanced education combined with experience.
• Requires a University Degree and a minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience.