Quality Engineer

Job Description

Quality Engineer
Manitowoc, WI
$85K to $110K (based on experience) +Benefits+ Quarterly Bonus+ Relocation Assistance

Required:
Experience in plastic injection molding.

This position will work with external customers, suppliers and internal personnel to complete Advanced Product Quality Planning (APQP) requirements and medical device process validation on all new and/or product changes, and corrective action implementation.

Responsibilities:

• Coordinate Automotive PPAP and Medical Validations for new and revised products. Will regularly compile PPAP and Validation reports and develop procedure manuals.
• Perform quality-engineering reviews of design documentation for compliance with stated requirements, including customer quality manuals and company quality records
• Use a structured problem-solving approach including problem definition, data collection and analysis, escalation identification and solution recommendation
• Conduct internal audits of quality procedures in compliance with quality standards.
• Support the Continuous Improvement initiatives of the company

Requirements

• A Bachelor's degree in Engineering, Quality or related field is required.
• 2-5 years of combined quality and manufacturing experience is required.
• Working knowledge of applicable regulations and standards such as FDA, ISO 13485, IATF 16949, Med Accred, etc.
• Working knowledge of process validation and verification activities, including Risk analysis and mitigation techniques including Process FMEA (Failure Modes and Effects Analysis), Process Flow Charts and Control Plans.

We are an equal opportunity employer that recognizes the value of a diverse workforce. All mage, sex, sexual orientation, gender identity, religion, national origin, disability, or any other criteria protected by governing law.