Senior Advanced Quality Engineer - Ventral Medical Device

Job description (Tasks/Responsibilities):

The position of Senior Advanced Quality Engineer is responsible for assuring that new product designs and the processes for manufacturing them meet all corporate and divisional requirements with respect to safety and efficacy.  This candidate will represent the quality interests and concerns of project teams and report to the Manager of Advanced Quality Engineering.  This position is geographically located on the east coast in Warwick, RI. Your responsibilities include: Provide technical guidance to Quality Engineers, Quality Technicians, and Inspectors. Lead Quality Engineering Projects to improve Quality Systems and Procedures. Development of Test Protocols and Final Reports to support Regulatory 510K or PMA submissions. Development of the DFMEA, coordinating input from the other Design Sub-team members. Development of the Design Verification Protocol and the subsequent Design Verification Report. Provide input into the project Design Input Summary (DIS), Product Performance Specification (PPS), Product Development Plan (PDP), and applicable design control documents as defined. Determine the degree of Biocompatibility testing required as per ISO10993 and company procedures. Develop test protocols and release a final report on Shelf Life and Stability Studies in support of expiration dating. Perform test method validations to ensure accuracy, precision, selectivity, sensitivity, stability, and reproducibility of analytical or physical test methods used to assess the safety and efficacy of devices. Develop shelf life and stability test protocols as required for combination devices with Active Pharmaceutical Ingredient’s (API’s). Special projects as assigned.

Skill Requirements:

Bachelor’s Degree required in Engineering or other technical discipline. Minimum of five years of experience in a quality engineering, including design controls or product/process validations, risk management, and technical problem solving, in the medical device or biotech industry. A high level of competence in quality technology including statistical techniques, control charts, sampling plans, quality costs, design of experiments, correlation and regression, analysis of variance, probability etc. Strong Design Control understanding from concept to launch. Applied Knowledge of the requirements of FDA QSR, ISO13485and ISO 9001. Relevant experience with one or more of the following device technologies:
- Resorbable Polymers
- Active Pharmaceutical Ingredients- Combination Devices
- Polymer Coating Processes

Knowledge and Application of Six Sigma/Process Excellence Tools.  Green Belt/Black Belt Certification a plus. Some travel required.

Education Requirements:

Bachelor’s Degree required in Engineering or other technical discipline.

Location (City/State):

Warwick, RI

Company Description:

A market leader in comprehensive soft tissue reconstruction, delivering trusted products and techniques for hernia repair, specialized surgical procedures, fixation and biologic implants.

To Apply:

To apply, contact Tracy Wolfe at twolfe@zingaro.com or (512) 327-7277