Senior Principal Quality Engineer - Remote Opportunity!!

ApiJect is seeking a Senior Principal Quality Engineer to support the development and maintenance of ApiJect’s quality systems programs, policies, processes, procedures, and controls ensuring that performance and quality of the Quality Management System complies with regulation, standards and agency guidelines. This position will configure and manage the electronic Quality Management System (eQMS).

• Strong technical background, communication, and presentation skills.
• Competent with use of Microsoft Office Suite (required) and Master Control (preferred).
• Applies continuous improvement principles in development of the quality system elements.
• Collaborate with cross-functional teams to optimize business processes, streamline workflows, and drive continuous improvement initiatives.
• Perform other duties, as assigned.
• Identify and implement changes to procedures and practices to enhance compliance and simplify ways of working; support stakeholders in mitigating quality system gaps.
• Required Quality experience in combination regulated devices/combination products and/medical devices at all stages of the product life cycle.
• Demonstrated ability to problem solve with a deep understanding of regulated devices.
• Extensive knowledge of device regulations including but not limited to, Design Controls, Risk Management, Change Control, Product Transfer, CAPA, PMS, Complaints Management, Adverse Event Reporting, EU MDR, and Labeling (UDI, GS1) as it relates to the execution of an efficient QMS.
• Ability to prepare reports, analyze and summarize data using statistical analysis for metrics reporting.
• Directly support and/ lead audits (internal, external, customer, ISO and/or FDA).
• Define and execute Quality CI initiatives related to supplier management and aspects of the QMS.
• Create, update, and maintain procedures and provide training, as needed.
• Develop and maintain infrastructures required to support ApiJect QMS.
• Strong knowledge of CAPA tools and statistical techniques.
• Strong knowledge of Quality Control, Lab best practices, GxPs, testing methodologies, and acceptance criteria.
• Monitors and reports on quality trends, performs investigations to identify underlying causes of defects in processes.
• Lead Auditor certification from external body (e.g. BSI, NSF, ASQ), preferred. Ability to perform audits at internal sites.
• Review audit responses for acceptability and collaborate with internal and external partners.
• Increase process consistency and customer service quality through use of a Lean Quality Management System, to achieve and sustain results to targets.