Paragon Medical, a business of AMETEK, Is a trusted partner in medical device manufacturing, offering end-to-end solutions from concept to final production. With expertise across various applications, we deliver high-precision components and complete products tailored to exceed customer expectations.
Job description:
Essential Job Functions:
- Assists in the development and implementation of systems and processes that foster continuous improvement for product development and/or manufacturing.
- Responsible for ensuring cell processes are correctly base lined and controlled. Known variability is to be accounted for through selection & frequency of inspection, sampling plans, or implementation of SPC.
- Completes the implementation and performance of gage R&R, process capability studies, design of experiments, and summaries as required to improve quality and to provide required deliverables to customers.
- Ensures processes released with use of SPC where applicable and/or promote the utilization of SPC.
- Provides SPC & ongoing monitoring of SPC.
- Investigates deviations, OOS, complaints, returns, recalls, and field alerts.
- Supports the Material Review Board (MRB) for internal non-conformances and customer returns.
- May lead or verify effectiveness of corrective and preventive actions (CAPAs).
- May liaise directly with customer representatives.
- Supervise and train personnel in the inspection of raw materials, in-process and finished goods by using statistical sampling techniques and precision measuring instruments to check conformance to requirements.
- Verify that all production procedures have been followed and the records such as Device Master Records and Device History Records are maintained per FDA & customer requirements and company requirements.
Education & Experience:
- Bachelor’s Degree in Engineering or related field with a minimum of two years’ experience with tight tolerance measurement systems in machining applications.
- Blueprint reading, GD&T, and a working knowledge of short-run process control methods.
- DOE, ISO standards, and FDA quality system regulations.
- Previous medical device experience preferred.
We offer:
- 401(k)
- Medical, Dental, Vision, Company Paid Life Insurance & Short-Term Disability
- Employee Assistance Program
- Paid Time Off
- Paid Holidays
