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Job Title: Quality Engineer II/Supplier quality Engineer

Location: North Haven Connecticut 06473

Contract duration: 12+Months

TECHNICAL SKILLS

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 tools (Creo/SolidWorks) and PLM/PDM tools (preferably Windchill).

·         Solid understanding of project management methodologies, including planning, tracking, and cross-functional collaboration.

·         Strong verbal and presentation skills for effective collaboration with global teams.

·         Well-versed in MS PowerPoint and Excel for report preparation, data analysis, and 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.

JOB DESCRIPTION

Position Summary

The Supplier Quality Engineer is responsible for managing finished goods Contract Manufactured (CM) products for Robotics Surgical Technologies.

Primary duties are focused on all QMS-related matters pertaining to:

·         Supplier selection

·         Processing supplier change requests

·         Part/process qualification

·         Manufacturing

·         QMS development

·         Technical quality, service, and cost improvements

The role will work with new and existing CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities, including:

·         MSAs

·         PPAP

·         SCR

·         Quality Plans

·         Control Plans

·         FMEAs

Top 3 Technical Skills Required

1.

Lead, support, review, and approve:

·         Supplier Change Requests (SCR)

·         Validation

·         TMV

·         PPAP

·         SCAPA

·         QMS activities

2.

Work with new and existing CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities, including:

·         Quality Plans

·         Control Plans

·         FMEAs

3.

Familiarity with medical industry requirements such as:

·         ISO 13485

·         21 CFR 820 standards

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 products.

·         Collaborate with engineering and manufacturing functions to ensure quality standards are established and maintained.

·         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.

·         Perform statistical analysis to assess costs and determine responsibility for products or materials that do not meet required standards and specifications.

·         Ensure corrective measures meet acceptable reliability standards and that documentation complies with applicable requirements.

·         May specialize in areas including:

o    Design Quality

o    Incoming Material Quality

o    Production Control

o    Product Evaluation and Reliability

o    Inventory Control

o    Research and Development Quality

o    Process Quality Management

LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.