Do you feel like just a number at work, just one of the crowd?  Then it’s time to make a change. Paragon Medical, is an industry leading medical device manufacturer. Paragon Medical is searching for dependable and committed individuals for our facility located in Fairfield, NJ.

SUMMARY OF POSITION:  Responsible for meeting customer requirements for the manufacturing of surgical instruments from receiving raw material through to the shipping of finished goods. Supports the development of and enforces internal systems and procedures to meet ISO standards and FDA quality system regulations. Develops and implements inspection/validation techniques necessary to verify products meet requirements at the earliest point in the production process. Specifies and implements new inspection equipment and instructs others in its proper use.

ESSENTIAL FUNCTIONS:

§         Practical implementation of systems and procedures for meeting ISO standards and FDA quality system regulations.

§         Supervise and train personnel in the inspection of raw materials, in-process and finished goods 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 and customer requirements.

§         Design inspection/validation steps to be taken by the machinist at the point of manufacture and integrate these steps into the manufacturing instructions.

§         Specify required inspection equipment and holding apparatus to accommodate repeatable measurements.

§         Work in conjunction with Business Unit Leaders and Cell Leaders to ensure machinists are knowledgeable and competent in the use and care of sensitive measuring equipment and related requirements such as calibration, recording of data, expected variability, etc.

§         Assist/lead company Lean/6 Sigma initiatives to remove variability and reduce cost. Q.E. is responsible for ensuring cell processes are correctly base-lined and controlled. Known variability is to be accounted for through selection and frequency of inspection or sampling plans.

§         Provide recurring support to assigned inspection technicians.

§         Assist in the inspection of surgical instruments and implants as required. Lead or assist in leading multi-function continuous improvement activities. 

§         Represent Paragon Medical in meeting with Customers to fully develop their requirements or as required in the manufacture of contracted products. Assist in both internal and external audits of all corporate quality systems and demonstrate compliance through objective evidence.

OCCASIONAL DUTIES:  Gage R&R studies, training others in statistical techniques and process control/validations. Calibrate and control all gages and measuring equipment used in production

EXPERIENCE:  Minimum 3-5 years experience with CMM and Optical measuring equipment in machining applications and a working knowledge of short run process control methods, DOE, ISO standards and FDA quality system regulations. Previous orthopaedic experience preferred.

EDUCATION: 4 year degree in Quality Engineering or related field. Willing to consider relevant experience in combination with professional certifications. 

SKILLS:  Excellent interpersonal, problem solving and communication skills.  Individual is able to work with minimal supervision and actively participate in a team oriented, continuous improvement, manufacturing environment.

**To apply for these positions please visit our website at www.paragonmedical.com **