Quality Engineer

Synergy Talent Solutions LLC; Menomonee Falls (WI); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A staffing agency is seeking Quality Engineers for a full-time position in Menomonee Falls. Candidates should have a BS in Engineering or a related field, with experience in a regulated manufacturing environment. The role involves developing quality systems, addressing customer complaints, and ensuring compliance with quality standards. Competitive benefits like medical insurance and a 401(k) are offered.

Qualifications

• Experience in a quality engineering role within a regulated manufacturing environment.
• Understanding of quality standards and regulatory requirements.
• Demonstrated experience in using quality tools.

Responsibilities

• Assist with the development of quality systems and procedures.
• Generate and implement ideas and solutions.
• Monitor and initiate customer complaints.

Skills

Quality standards understanding

Excellent interpersonal skills

Continuous improvement projects

Experience with Microsoft Office

Education

BS in Engineering or related technical field

Tools

ISO 9001

ISO 13485

Job description

Our client located in the Germantown/Menomonee Falls area are seeking Quality Engineers for their 1st shift team. As a Quality Engineer you will assist with the development of quality systems, procedures and controls to ensure that all products consistently meet performance and quality specifications in the manufacturing facility. The Quality Engineer is a leader and strong technical resource who quickly and effectively resolves quality problems with internal and external customers and suppliers.

Duties and Responsibilities

• Generates, communicates, and implements ideas and solutions.
• Demonstrates accuracy and thoroughness in completing tasks timely.
• Looking for ways to improve and promote quality.
• Monitor Corrective Action System (i.e. Customer Complaints, Supplier, Internal)
• Initiate and investigate Customer Complaints according to the company’s internal procedure and standards.
• Record essential information on internal and/or customer-specific documentation, including updating customer portals.
• Perform investigations using Lean, Six Sigma, and statistical methods to support root cause analysis and corrective actions.
• Identify gaps and/or trends in systems or processes.
• Initiate and facilitate the Corrective/Preventative Action process using the appropriate quality tools and input from Subject Matter Experts (SME) to implement sustainable solutions.
• Update Quality documents according to Company’s Change Control procedures, as required.
• Drive Non-Conformance Process
• Evaluate and investigate suspect non-conforming product identified by manufacturing and/or the Quality Lab.
• Initiate containment activities, as necessary, with Customer Service and Shipping Department.
• Recommend disposition of product based on thorough investigation and data-driven feedback.
• Initiate and assist Customer Service with Return Material Authorization (RMA) process.
• Develop re-inspection, sort, and/or rework instructions for Manufacturing Operators, as required.
• Collaborate with customer(s) on issuing waiver or deviation documentation and obtain customer approval, as required.
• Maintain the Quality Management System (QMS)
• Understand ISO 13485 Quality management systems requirements.
• Ensure continuing compliance to both internal Company processes as well as requirements imposed upon Company by certification bodies, regulatory agencies, and specific customer requirements.
• Assist in internal, 2nd party, and 3rd party audits.
• Assist with responses and corrective actions for audit findings.
• Participate in design review, process planning, and failure mode analysis
• Provide input on evaluation of Key Product Characteristics.
• Provide input on gaging methods and equipment.
• Interpret customer requirements including complex blueprints and GD&T call-outs.
• Review and approve Engineering Change Notifications and Verifications
• Evaluate for feasibility and implement updates to customer requirements into associated product control plans, pFMEA, Inspection documentation and other related documents.
• Incorporate industry standard best practices.
• Evaluate, submit and track Supplier Change Notices to customers and/or suppliers.
• Any other duties as assigned.
• Manufacturing point of contact for the review and disposition of product quality related questions.
• Approve Healthcare Device release for shipment, as required
• Perform batch record reviews for medical device prior to release for shipment.
• Generate Certificate of Analysis, as required.
• Release product in ERP system based on customer and Company process requirements.
• Support Manufacturing process
• Train Manufacturing and Quality Control personnel on customer requirements, inspection techniques, lessons learned, and rework instructions.
• Manage product inspection and testing activities.
• Obtain customer approvals for all required changes based on Quality Agreements.
• Compile supporting measurement and process performance data, as necessary
• Assemble supporting documentation package and review for completeness and accuracy
• Review and approve production documentation updates according to MGS Engineering Change Order process.

Experience and Skills

• BS in Engineering, Quality, or related technical field is preferred.
• Experience in a quality engineering role within a regulated manufacturing environment (Healthcare Device a plus).
• Understanding of quality standards and regulatory requirements: ISO 9001, ISO 13485, 21 CFR Part 820.
• Understanding of best practices for cleanroom gowning and cleanliness requirements for manufacturing within a cleanroom.
• Experience with Microsoft Office products – Excel, Word, PowerPoint
• Greenbelt Certification is a plus.
• Demonstrated experience in driving continuous improvement projects and using quality tools (e.g., DMAIC, 8D, PFMEA, SPC, MSA, DOE).
• Excellent interpersonal, communication, and presentation skills.
• GD&T experience is a plus.

Seniority level

• Associate

Employment type

• Full-time

Job function

• Quality Assurance

Industries

• Plastics Manufacturing

Inferred from the description for this job

• Medical insurance
• Vision insurance
• 401(k)