Quality Technician
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Job Location:
Gardner, KS - USA
Monthly Salary:
Not Disclosed
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Job Summary
About Us:
We are a leading provider of prototype and low-volume production services specializing in 3D printing urethane casting CNC machining and plastic injection molding. We serve high-demand industries including medical defense and industrial markets. We are ISO 13485 certified and committed to delivering high-quality precision components.
Position Summary:
We are seeking a skilled Quality Technician with hands-on experience in CMM programming and operation plastic molding inspection and regulated quality systems. The ideal candidate will support our quality assurance efforts by performing AQL inspections first article inspections PPAPs validation protocols and ensuring compliance with ISO 13485 standards.
Key Responsibilities:
- Program and operate CMMs (preferably PC-DMIS or similar) to inspect precision components
- Conduct first article inspections (FAI) in-process inspections and final inspections using appropriate tools and methods
- Prepare and maintain documentation for PPAP IQ/OQ/PQ validations and device history records (DHR)
- Support quality system maintenance internal audits and corrective/preventive actions (CAPA)
- Interpret 2D drawings GD&T and customer specifications to validate conformance
- Assist in maintaining calibration systems for gages fixtures and inspection equipment
- Collaborate with production engineering and quality teams to resolve quality issues
- Support customer and regulatory audits
- Ensure compliance with ISO 13485 FDA QSR and customer-specific requirements
Qualifications:
- 3 years of experience in a manufacturing environment (preferably in plastic injection molding or medical devices)
- Proficient in CMM programming and operation (PC-DMIS Calypso or equivalent)
- Strong understanding of GD&T blueprint reading and metrology tools
- Experience with PPAP FAI and validation protocols (IQ/OQ/PQ)
- Familiarity with ISO 13485 FDA or other regulated quality systems
- Working knowledge of Microsoft Office and quality documentation systems
- Excellent attention to detail and documentation accuracy
- Strong communication and problem-solving skills
Preferred Qualifications:
- Associates degree in Engineering Technology Quality or related field
- ASQ certification (CQT or CQI) is a plus
- Experience with statistical process control (SPC) Minitab or similar tools
Benefits:
- Competitive pay
- Health and dental insurance
- 401(k) with company match
- PTO and paid holidays
- Growth and training opportunities
Required Experience:
Senior IC
Key Skills
- Quality Assurance
- Quality Inspection
- Calipers
- Coordinate Measuring Machine
- Food Industry
- GD&T
- ISO 9001
- Math
- Micrometer
- Quality Control
- HACCP
- Manufacturing
About Company
Mack Molding is a leading custom plastics molder and contract manufacturer with specialties in plastics design, rapid prototyping, injection molding, sheet metal fabrication and medical device manufacturing.
