Quality Engineer II - Exempt

Join our dynamic team in North Haven, CT, a vibrant location that offers a perfect blend of professional growth and quality living. We are seeking a skilled professional to manage finished goods Contract Manufactured (CM) for Robotics Surgical Technologies. This role focuses on all Quality Management System (QMS) related matters, including supplier selection, processing supplier change requests, part/process qualification, manufacturing, QMS development, and technical quality/service/cost improvements.

Must Have

• Bachelor’s degree in mechanical/production engineering with 9–12 years of relevant experience.
• Strong expertise in Design for Manufacturability & Assembly (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.
• 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, Test Method Validation (TMV), PPAP, Supplier Corrective Action and Preventive Action (SCAPA), QMS, etc.
• Develop, implement, and maintain technical quality assurance systems and activities including Quality Plans, Control Plans, and Failure Modes and Effects Analysis (FMEAs).
• Familiarity with the Medical industry requirements such as ISO 13485, 21 CFR 820 standards.

Responsibilities

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

• Develops, modifies, applies, and maintains quality standards and protocols for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in areas such as design, incoming material, production control, product evaluation and reliability, inventory control, and/or research and development as they apply to product or process quality.

Education and Experience Required

• University Degree in Engineering/Scientific/Electronic or technical field.
• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.

This position requires working onsite at our North Haven, CT location, 40 hours per week. Interviews are being scheduled now, so apply today to join a leading team in Robotic Surgical Technologies support contract manufacturing.