We are seeking a dynamic Quality/Regulatory Engineer to join our growing Regulatory Affairs/Quality Assurance (RA/QA) Department. As the Quality/Regulatory Engineer you will support and contribute to the overall Quality Management System, apply the requirements to our processes, products or services, and ensure compliance to applicable laws, regulations and standards. You will actively participate in quality improvement endeavors while working collaboratively and cohesively with employees to resolve issues.

Under the supervision of Regulatory Affairs/Quality Assurance (RA/QA) Director, you will:

• Ensure compliance of design, development, and testing by performing gap assessment against current relevant and applicable regulations and remediation of the Design History File for commercial product
• Lead or participate in the development, implementation, compliance, and maintenance of standards (e.g., FDA, ISO 9001:2015, ISO 13485:2016, CE/UKCA/UL/SGS, etc.) and procedures
• Support the manufacturing line to investigate and address quality issues
• Monitor product and process performance metrics and act upon trends
• Author, collaborate, and approve Quality System documentation including change orders, DHF, DMR, DHR, labels and labeling, etc.
• Conduct internal, vendor, and process audits
• Interface with suppliers to resolve quality issues
• Assist in training personnel on all aspects of the Quality System and regulatory standards

Position Qualifications:

• Bachelor’s Degree in Mechanical or Biomedical Engineering or related engineering or scientific discipline
• Minimum five years of Quality Engineering experience preferably with technical knowledge and experience in the Quality Assurance and/or regulatory functions as well as the medical device industry
• ISO 9001, ISO 13485 and cGMP (21 CFR 820) experience is a plus
• Strong self-starter, effective team player
• An effective oral and written communicator with the ability to lead meetings and clearly present ideas to employees and other stakeholders
• Knowledge of Microsoft Office Suite