Analysis Skills, Clinical Laboratory, Continuous Improvement, Corrective Action, Data Analysis, Data Collection, External Audit, FDA Requirements, Green Business, ISO (International Organization for Standardization), Internal Audit, Manufacturing, Manufacturing/Industrial Processes, Medical Equipment, Problem Solving Skills, Procedure Development, Process Engineering, Product Development, Product/Service Launch, Production Support, Purchasing/Procurement, Quality Assurance, Quality Assurance Methodology, Quality Management, Regulatory Compliance, Regulatory Requirements, Risk Management, Root Cause Analysis, Statistical Process Control, Statistical Sampling, Time Management, Validation Testing
Hardy Diagnostics a 100% employee owned company and is now hiring!
We are looking for another dedicated person to join us. We have an immediate opening for a full time QA Process Engineer. If you have a passion for excellence and would like to join a stable and growing company then wed like to talk to you.
The QA Process Engineer supports compliance with applicable regulatory requirements by maintaining an effective quality management system and implementing continuous improvements. This position is responsible for activities ranging from product development through commercialization. This is a hands-on role where the QA Process Engineer will apply diversified knowledge of engineering, quality principles and practices for medical devices and laboratory use only products.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may
be assigned.
- Maintains and improves the quality system in accordance with FDA Quality System Regulation and ISO 13485 requirements
- Supports quality assurance activities, including, but not limited to: Risk Management, internal and external audits, NCMRs and CAPAs
- Investigates product quality problems (NCs and deviations) and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause
- Manages the Control of Non-conforming Products (CNP) in collaboration with the applicable stakeholders, to ensure timely reporting, analysis, and resolution of non-conforming material
- Leads/supports the resolution of quality issues related to non-conformance reports, deviations, customer complaints and CAPAs
- Oversee the deviation process for the review and approval of manufacturing deviations
- Supports manufacturing team in the maintenance and continuous improvement of product and manufacturing processes
- Leads and administrates the CNP and CRB meeting
- Serves as subject matter expert for root cause analysis
- Provides QE support to production, purchasing and engineering
- Supports/leads test method validation activities and/or other validation activities as needed
- Develops and initiates sampling procedures and statistical process control methods
- Other duties/ activities may be necessary to support departmental or company goal
EDUCATION and/or EXPERIENCE
- Bachelor's degree (B.S./B.A.) in engineering or related discipline
- Minimum three (3) years of experience working in a regulated industry
- Minimum two (2) years of experience in quality in a regulated industry
We also help make our employees better by offering a wide range of educational and training opportunities as well as a full line of benefits, including profit-sharing. Our employees eventually become owners through our Employee Stock Ownership Program (ESOP). The dedication and skill of the people who work here have resulted in remarkable success--Inc. Magazine has recognized us as one of the Fastest Growing Private Companies in America. In addition, we are a "Fit Friendly" business as certified by the American Heart Association and a "Green Business" as certified by the County of Santa Barbara.
Hardy Diagnostics is an Equal Opportunity Employer: Minorities / Females / Veterans / Disability