Job Type Full-time Description Carolina Precision Technologies (CPT) is a premier, full-service precision manufacturer for the medical and aerospace industries. We are a market leading manufacturer of implants, specialty surgical instruments, cutting tools, and delivery systems for the orthopedic, sports medicine, trauma, extremities and other MedSurg applications. We are currently seeking a full time Quality Control Lead Inspector at our facility in Warminster, PA. The ideal candidate will have experience in a machine shop/production environment with good communication and an ability to learn quickly. Responsibilities include but not limited to:
- Perform root cause investigations and initiate corrective and preventive actions as required per documented procedures within the QMS. Perform effectiveness checks to ensure all actions taken are implemented and effective at eliminating the original root cause of the issue.
- Communicate with customers/suppliers as needed regarding complaints, corrective and preventive actions.
- Reading/understanding customer specifications, drawings (including GD&T) and create inspection plans based on the customer's documented requirements.
- Perform first article, first piece, in process and final quality inspections to ensure conformance to customer requirements provided through blueprints, specifications and control documents prior to product release.
- Conduct re-inspection for nonconforming product found in-house or returned from customers.
- Communicate all quality issues to management in a timely manner, along with recommendations for any corrective or preventive actions that may be necessary.
- Manage the calibration program and ensure all inspection tools are properly calibrated per stated requirements. Schedule all calibration activities to ensure no tools are used that are past or out of calibration. Monitor and track all tools within the Calibration Log.
- Perform internal calibrations/verifications as needed.
- Perform raw material and product receiving inspection activities from outside services/suppliers as needed.
- Develop/Suggest changes to current QMS procedures/work instructions in order to continuously improve and streamline all processes within CPT.
Minimum Requirements:
- Must be 18 years old
- High School diploma or GED preferred
- Minimum 3 years on the job experience in a machine shop environment
- Familiarity with ISO 13485, and FDA requirements
- Familiarity with AQL inspection methods
- Ability to utilize all inspection tools including calipers, micrometers, comparators, CMM etc.
- Experience with 3-dimensional inspection and measurements
- QC experience in medical devices preferred
- Knowledge and understanding of engineering drawing interpretation with GD&T specified features
- Must possess organizational ability in order to set priorities, organize workload, and meet deadlines
- Internal Auditor experience is preferred.
- Strong PC skills, including Microsoft Office (Word, Excel, Access)
- Excellent record-keeping documentation and organizational skills
- Ability to use ERP systems (Preferably VISUAL)
- Able to bend, stoop, twist, reach, lift 40 pounds and stand on feet for an extended period of time
Benefits Competitive salary including a full range of health benefits, paid time off, 401k with company match after 3 months of service. Pay will be based on experience.