Quality Engineer I - Cardio at Cretex… · Coon…

Summary: Cretex Companies, Inc. is a provider of contract manufacturing for high-quality medical implants and components. They are seeking a Quality Engineer I to provide quality assurance support for manufacturing operations, focusing on implementing and enhancing quality-related practices while fostering an inclusive environment. Responsibilities: - Quality engineering support for manufacturing and project management - Develop inspection requirements; facilitate PFMEAs; resolve discrepant material issues and create and maintain quality document such as control plans and inspection plans - Analyze data and identify improvement opportunities - Act as the quality interface for a production team in responding to customer complaints using failure analysis, development of corrective and preventative actions and trend analysis - Support internal and external audit activity - Lead and participate in company projects providing quality recommendations - Support validation activity of processes, equipment, and metrology - Create protocols and analyze data - Support the Quality Inspectors to ensure that inspection plans comply with the relevant requirements of customer’s product requirements - Support and comply with the company Quality System, ISO, and medical device requirements - Read, understand, and follow work instructions and standard work - Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance - Understand customer needs and the core business markets we serve - Ensure business systems are implemented, maintained, and functioning properly - Participate in required company meetings - Maintain an organized work area (5S) - Participate in the Operational Excellence Program - Complete all other work duties as assigned - Ability to work in a manufacturing environment Required Qualifications: - Bachelor's Degree in Mechanical, Industrial, or in another Engineering Science - Knowledge of quality systems, regulatory requirements, and industry standards - Intermediate knowledge of blueprint reading and GD&T - Ability to analyze data and ensure data integrity - Ability to operate a variety of inspection equipment - Ability to consistently achieve short and long-term business results - Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher) - Clear and effective verbal and written communication skills - Attention to detail - Organizational skills - Ability to work in a fast-paced team environment - Ability to prioritize and multitask Preferred Qualifications: - Statistical expertise with DOE and Capability Studies - Design software- Minitab - Process management - Continuing Education; including participation in local chapters, associations, and/or organizations Required Skills: Quality systems, Regulatory requirements, Industry standards, Blueprint reading, GD&T, Data analysis, Inspection equipment operation, Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Publisher, DOE (Design of Experiments), Capability Studies, Minitab Benefits: Medical, dental, vision and life insurance options, 401(k) retirement plan with employer match, Profit sharing, Short- term and long-term disability insurance, Paid time off, Holiday pay, Onsite medical clinic, Onsite Clinic, Paid Parental Leave, Monthly Social Events, Annual Employee Appreciation Week, Volunteer Opportunities, Training and Development Opportunities, Tuition Reimbursement, Wellness Program, Comprehensive medical insurance with access to virtual providers, Dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider), Vision insurance, A pre-tax health savings account, Healthcare and dependent care pre-tax reimbursement accounts, Paid holidays, Paid time off, Discretionary profit sharing program, Parental Leave, Accident and critical illness benefits, Optional employee, spouse, and child life, Short and long term disability, Company provided life insurance, Tuition assistance programs