Quality Control Supervisor
Warminster, PA • Quality
The Company 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 orthopedic, sports medicine, trauma, extremities, and other MedSurg applications. We are seeking a full-time Quality Control Supervisor at our facility in Warminster, PA. The ideal candidate will have experience in a production environment with good communication and an ability to learn quickly.
Responsibilities include but are not limited to the following:
- Supervise Inspection staff and ensure inspections are being performed. Monitor job performance and delegate product inspections to inspectors to ensure the product is inspected promptly and efficiently based on the importance/delivery schedule.
- Perform on-the-job training for newly hired inspection staff and ongoing training for product-specific requirements.
- 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 regarding complaints and corrective and preventive actions.
- Reading/understanding customer specifications and drawings (including GD&T) and creating inspection plans based on the customer’s documented requirements.
- Perform the first article, the first piece, in process, and final quality inspections to ensure conformance to customer requirements provided through blueprints, specifications, and control documents before product release.
- Conduct re-inspection for nonconforming products found in-house or returned from customers.
- Communicate all quality issues to management promptly, along with recommendations for any corrective or preventive actions that may be necessary.
- Manage the calibration program and ensure all inspection tools are correctly calibrated per stated requirements. Schedule all calibration activities to ensure all devices that are present and out of calibration are used. Monitor and track all tools within the Calibration Log.
- Perform internal calibrations/verifications as needed.
- Perform raw material and product-receiving activities from outside services/suppliers as needed.
- Develop/Suggest changes to current QMS procedures/work instructions to continuously improve and streamline all processes within the Company.
- Must be 18 years old
- High School diploma or GED preferred
- Three years of job experience in related fields preferred
- 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 the organizational ability 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
Competitive salary including a full range of health benefits, paid time off, 401k with company match after three months of service. Pay will be based on experience.
60,000 to 75,000 per year
Click here to apply online