Quality Engineer II - Exempt

Job Description

Job Description

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.