Description

ApiJect is seeking a Principal Quality Systems Specialist 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).

Extensive knowledge of regulations including EU MDR 2017/745, ISO 14971:2019, ISO 13485:2016, CFR Part 820, CFR Part 210/211, CFR Part 11, and TGA.Extensive knowledge of Design Controls, Risk Management, Change Control, Product Transfer, CAPA, PMS, Supplier Management, Complaints Management, Adverse Event Reporting, and Labeling (UDI, GS1) and demonstrated experience integrating into the Quality Management System.Ability to prepare reports, analyze and summarize data using statistical analysis for metrics reporting and participation in Management Review.Extensive knowledge of auditing methodologies. Directly support and/ lead audits (internal, external, customer, ISO and/or FDA). Front room & back room audit experience, scribing, etc. required.Define and execute Quality CI initiatives related to supplier management and other aspects of the QMS.Author and review of Quality Management SOPs and technical documentation in the electronic document management system.Monitor and report on quality trends, perform 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 and supplier sites.Investigate internal and external audit responses.Collaborate effectively interface with internal and external customers.Increase process consistency and customer service quality through use of a Lean Quality Management System, to achieve and sustain results to targets.Serve as the SME and independently manage and monitor quality systems such as Document Management, Supplier, Change Control, PMS, and CAPA.Manage reference/working standards and develop robust processes for standards management.Perform Quality System gap assessments and execute Quality Plans.Develop and implement strategies to assist with major audit deficiencies, including development of FDA 483 responses and notified body responses.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

https://www.linkedin.com/jobs/view/4020810805

Requirements

Position Requirements

Bachelor’s degree in a science based major (e.g. Mathematics, Engineering, Biology, etc.) with 8 years of related experience (required).3+ years leading quality professionals (preferred).Self-starter, driven, energetic, and self-assured individual with high degree of personal integrity and accountability; ability to develop effective interpersonal relationships.Highly organized, detail-oriented, and possesses extensive understanding of quality management systems, standards, and regulations.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.Ability to work cross functionally and gain support of other functions in alignment with corporate goals.Ability to think strategically and define and execute tactical day-to-day tasks.Effectively communicate with vendors and associates at all levels of the organization.Must have exceptional written and oral communication skills.Must be proficient in MasterControl eQMS.

About the Organization ApiJect Systems, Corp.™ is a medical technology company creating the future of pharmaceutical injections. ApiJect products are designed to provide the advantages of prefilled syringes (quality, convenience, safety) at the cost-efficiency of multi-dose formats, regardless of manufacturing volume.

Our Platform achieves this by bringing together two globally trusted manufacturing technologies: Blow-Fill-Seal (BFS) aseptic filling and high precision injection molding. This approach can be seen in our first prototype device that is in development, a single-dose prefilled injector, designed to expand current commercial markets and also help improve global health access so more healthcare workers can give patients the medicines and vaccines they need

We are a small, fast-growing company with a remote workforce located primarily in the United States, but also with colleagues, offices, and/or close manufacturing partners in Europe and Asia.

EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.

https://www.linkedin.com/jobs/view/4020810805