Quality Engineer

Job Description

Job Description

Quality Engineers - 2 OPENINGS - HIRING AT BOTH R&L SPRING COMPANY and MEDICOIL
Location: Lake Geneva, WI
Company: R&L Spring Company and Medicoil

About the Role:
R&L Spring Company and Medicoil are both seeking Quality Engineers.

The Quality Engineer reports to the Quality Manager and is responsible for supporting and improving the Quality Management System (QMS) through analysis, auditing, problem-solving, and continuous improvement initiatives. This role partners closely with Engineering, Manufacturing, Suppliers and Customers to investigate quality issues, implement corrective actions, reduce risk and ensure compliance with applicable quality standards and customer requirements.

This position supports both internal and external quality initiatives, including audits, validations, supplier quality, process improvement and new product development activities within a manufacturing environment.

Duties/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

Required Skills/Abilities

• Strong understanding of quality systems, manufacturing processes, and continuous improvement principles
• Working knowledge of ISO 13485, ISO 9001, IATF 16949, GMP, and quality assurance methodologies
• Experience with AIAG Core Tools including PFMEA, Control Plans, SPC, MSA, and PPAP
• Ability to read and interpret engineering drawings, blueprints, GD&T, and technical specifications
• Strong problem-solving, analytical, and root cause analysis skills
• Excellent organizational skills and attention to detail
• Effective written and verbal communication skills
• Ability to work effectively in a fast-paced manufacturing environment
• Proficiency with Microsoft Office applications
• Project management and cross-functional collaboration experience preferred
• Knowledge of validation and verification processes including IQ/OQ/PQ preferred

Education and Experience

• 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

Physical Requirements

• Prolonged periods of sitting and working on a computer
• Ability to occasionally lift up to 50 pounds
• Ability to work within a manufacturing environment as needed

Work Location

This position is fully onsite in Lake Geneva, WI and requires daily in-person attendance in a manufacturing environment.