Quality Engineer - ISO & Continuous Improvement Specialist

R&L Spring Company; Wisconsin; On-site; USD 72,000 - 98,000; Full time

Job summary

R&L Spring Company and Medicoil are seeking Quality Engineers to support the Quality Management System (QMS) and drive audits, corrective actions, and continuous improvement in a manufacturing environment in Lake Geneva, WI.

The role partners with Engineering, Manufacturing, Suppliers and Customers to investigate quality issues, ensure compliance with ISO and IATF standards, and develop robust quality documentation and validation plans for new product development.

Qualifications

• Engineering degree or equivalent combination of education and experience preferred.
• Minimum 2 years of quality engineering or quality systems experience in a manufacturing environment.
• Experience with medical device and/or automotive quality systems preferred.
• Auditor certification or auditing experience preferred.
• Experience with wire forming, plating, coatings, or metal manufacturing processes is a plus.
• Certified Quality Engineer (CQE) certification preferred

Responsibilities

• Support and coordinate internal, customer, and certification audits of the Quality Management System (QMS)
• Assist in maintaining compliance with ISO 13485:2016, ISO 9001, and/or IATF 16949 requirements
• Recommend improvements to align company procedures with quality standards and customer requirements
• Support and lead internal audit activities according to established schedules
• Coordinate and conduct layered process audits, product audits, and manufacturing process audits
• Develop and maintain quality documentation including procedures, work instructions, inspection plans, control plans, and process flow diagrams
• Create and support PFMEAs, risk assessments, acceptance criteria, and quality validation plans
• Perform root cause investigations and lead corrective and preventive actions (CAPA/CAR/PAR)
• Analyze non-conformances (NCRs) and work cross-functionally to implement effective corrective actions
• Interface directly with Engineering, Manufacturing, Document Control, Suppliers, and Customers regarding quality-related issues
• Support supplier qualification activities, supplier assessments, and Approved Supplier List (ASL) management
• Assist with Production Part Approval Process (PPAP) activities including dimensional layouts, SPC, MSA, process controls, and supporting documentation
• Perform inspections, product layouts, testing reviews, and data analysis as required
• Support validation and verification activities including IQ/OQ/PQ and process validation
• Identify process and product risks and support continuous improvement initiatives
• Assist in quality planning activities for new product development and manufacturing processes
• Develop training recommendations and support quality-related employee training activities
• Ensure accurate and timely reporting of quality data and documentation
• Support quality assurance and quality control activities throughout the organization
• Perform additional duties as assigned by Quality Management

Skills

Quality systems

Manufacturing

Continuous improvement

Problem solving

Documentation & reporting

Education

Engineering degree

CQE certification preferred

Tools

PFMEA

Control Plans

SPC

MSA

PPAP

Job description

R&L Spring Company and Medicoil are seeking Quality Engineers to support the Quality Management System (QMS) and drive audits, corrective actions, and continuous improvement in a manufacturing environment in Lake Geneva, WI.

The role partners with Engineering, Manufacturing, Suppliers and Customers to investigate quality issues, ensure compliance with ISO and IATF standards, and develop robust quality documentation and validation plans for new product development.