Position Title:Quality Engineer – Product Realization / Quality Systems
Reports To:Director of Quality Assurance / Regulatory Affairs
Design review participation to facilitate the design and development process to ensure production processes, procedures and equipment are implemented per the requirements of ISO 13485.
Participate in team, organizing and/or completing IQ’s, OQ’s, and PQ’s and ensure validations are completed and approved prior to production.
Coordinate and ensure effective design transfer functions for new products.
Ensure that the new product introductions and change controls are effectively managed in accordance with the requirements of ISO 13485 and 21 CFR Part 820.
Ensure that the necessary testing, evaluation, and control of equipment measures are in place to monitor and support product quality in accordance with the requirements of ISO 13485 and 21 CFR Part 820.
Prepare the monthly management review report, submit to the Director of Quality for review, conduct the meeting with Top Management and issue the report.
Participate in CAPA program and product disposition.
Collect water samples for LAL and Bioburden testing and monitor that water collection, and testing results comply with applicable USP’s and SOP procedures.
Participate in the Internal Quality Audit Program.
Schedule and participate in the Customer Quality Audits.
Mechanical/Industrial Engineering Degree or similar technical degree preferable
ISO 13485:2016 Audit Certifications ASQ CQA/CQE preferred
Two to three years Quality/Process/Manufacturing Engineering experience with Medical Device Company
Six Sigma Green Belt preferred
Regulatory Affairs experience including 510(k) submissions and FDA interface preferred
Ability to input and analyze data accurately
Familiar with contractual requirements and review function
Familiar with quality specifications, procedures, and manuals
Ability to perform project management functions including scheduling, follow-up and closure
Excellent communication skills
Halkey-Roberts Corp., located in St. Petersburg, FL and has been providing original equipment manufacturers with innovative, cost efficient, quality components for over sixty years. We design, manufacture and sell medical, inflation, and pressure relief products for the commercial, aviation, transportation, military and medical industries. Halkey-Roberts is a wholly owned subsidiary of the Atrion Corporation. We are committed to total customer satisfaction. That commitment is reflected in the quality of our products and the innovations we have introduced over the past six decades.