Quality Engineer III
Cretex Medical Component and Device Technologies
Summary
The Quality Engineer III will be responsible for providing quality assurance support for manufacturing. This position is responsible for the definition, implementation, and improvement of quality related practices and will provide technical guidance and measurement methodologies support.
Job description
Position Summary
The Quality Engineer III will be responsible for providing quality assurance support for manufacturing. This position is responsible for the definition, implementation, and improvement of quality related practices and will provide technical guidance and measurement methodologies support.
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
- Conduct audits, including closing out audit findings, create audit finding reports and determine proper corrective and preventative actions
- Coach and mentor Quality Engineer levels, I and II
- Subject matter expert in one or more areas of the ASQ (American Society for Quality) QE BOK (Body of Knowledge)
- Lead and participate in large company projects providing quality recommendations
- Support Quality Inspectors to ensure that inspection plans comply with the relevant requirements of customer’s product requirements
- Support validation activity of processes, equipment, and metrology
- Create protocols and analyze data
- Ensure business systems are implemented, maintained, and functioning properly
- 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
- 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
Qualifications
- Bachelor’s Degree in Mechanical, Industrial, or in another Engineering Science
- 6 years of experience in engineering in a machining or manufacturing setting
- Knowledge of quality systems, regulatory requirements, and industry standards
- Advanced knowledge of blueprint reading and GD&T
- Ability to operate and train to a variety of inspection equipment
- Statistical expertise with DOE and Capability Studies
- Design software- Minitab
- Process management
- Ability to consistently achieve short and long-term business results
- Experience with ERP and quality systems
- 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
Desirable Criteria & Qualifications
- Experience in injection molding
- Experience in the med device industry
Requirements
- Bachelor’s Degree in Mechanical, Industrial, or in another Engineering Science
- 6 years of experience in engineering in a machining or manufacturing setting
- Knowledge of quality systems, regulatory requirements, and industry standards
- Advanced knowledge of blueprint reading and GD&T
- Ability to operate and train to a variety of inspection equipment
- Statistical expertise with DOE and Capability Studies
- Design software- Minitab
- Process management
- Ability to consistently achieve short and long-term business results
- Experience with ERP and quality systems
- 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
Benefits
- 401(k) Matching
- Onsite Health Clinics
- Discretionary Holiday Bonus
- Cretex University
- Employee Assistance Program
- Wellness Program
- Employee Death Benefit
- Sick and Safe Leave
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Health Savings Account
- Paid Holidays
- Paid Time Off
- Profit Sharing
- Parental Leave
- Accident & Critical Illness
- Life Insurance
- Short & Long Term Disability
- Tuition Assistance
Company overview
Cretex Medical Component and Device Technologies is a specialized medical device manufacturing company that focuses on producing precision components and complete device assemblies for the healthcare industry. The company operates as a contract manufacturer and supplier of critical medical components, serving original equipment manufacturers (OEMs) in various medical sectors. Their expertise lies in manufacturing complex medical device components that require high precision, strict quality control, and compliance with rigorous medical standards. The company's capabilities typically include injection molding, machining, assembly, and finishing processes for medical devices. They work with a range of materials suitable for medical applications, including various plastics, metals, and biocompatible materials. As a medical device component manufacturer, Cretex plays a crucial role in the medical device supply chain by providing OEMs with reliable, high-quality components that meet regulatory requirements for safety and efficacy. Their services help medical device companies bring innovative healthcare solutions to market while maintaining cost-effectiveness and manufacturing excellence.