Quality Engineer

Responsibilities:

Establish and maintain master validation program, including site and individual products and process master validations

Create/Review/Support validation protocols and reports to support process and reliability improvements

Support complaint handling program, including complaint analysis, investigation, and follow up

Lead and/or support reliability and process improvements projects from quality perspective

Establish and maintain process controls/SPC for specific production processes

Support corrective and preventive action (CAPA) program

Review and modify product designs and process documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and conformance to product and quality system requirements

Demonstrate product compliance for sterilization, biocompatibility, package integrity, shelf life, reliability, and electrical safety

Review and provide feedback of protocols and reports, test vendor qualification, and testing management

Assist with the development and maintenance of product risk management files

Assist with design verification testing and test method assessment and validation activities

Recommend requirements for first article inspection, incoming and in-process inspections, and lot releae testing, including sampling strategy and test methods

Participate in failure investigations to analyze internal system or process failures and to implement corrective and preventive action

Participate in component and service new supplier evaluation. Works with suppliers to ensure appropriate quality controls are implemented

Audit Design History Files and works with cross functional team to resolve documentation issues

Identify and implement good quality engineering practices, including statistical methods and root cause analysis tools

Participate in supplier material related processes which include coordination of MRB activities to ensure the timely assessment of potential non-conforming products

Support continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develop, and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions

Demonstrate the ability to implement ISO 14971, including risk evaluation techniques

Requirements:

Bachelor's degree preferably in an engineering or scientific discipline from a four-year college or university

5 years related experience and/or training; or equivalent combination of education and experience Medical Device or Class II device experience preferred, will consider experience from other regulated industries such as pharmaceutical, military or nuclear

A working knowledge of the FDA Quality System Regulation, ISO 13485, ISO 14971, ISO10993,ISO 11135, and the EU Medical Device Directive is a plus

Familiarity with test methods and standards for the design, verification, and validation of medical device products is required

Experience with PPAP, PMEA