Quality Assurance Specialist
3 days ago
Cretex Medical Component and Device Technologies is seeking a highly skilled Quality Assurance Specialist to provide quality assurance support for manufacturing. This role is responsible for defining, implementing, and improving quality-related practices and providing technical guidance and measurement methodologies support.
Key Responsibilities- Provide quality engineering support for manufacturing and project management
- Develop inspection requirements, facilitate PFMEAs, resolve discrepant material issues, and create and maintain quality documents 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, creating audit finding reports, and determining proper corrective and preventative actions
- Lead and participate in intermediate 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
- Bachelor's Degree in Mechanical, Industrial, or in another Engineering Science
- 3 years of experience in engineering in a machining or manufacturing setting
- Knowledge of quality systems, regulatory requirements, and industry standards
- Intermediate knowledge of blueprint reading and GD&T
- Ability to operate 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
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