Quality Assurance Engineer

Nitinotes - Quality Assurance Engineer Position

Company Overview:

Nitinotes is a medical device company developing a minimally invasive endoscopic suturing system for the safe and effective treatment of obesity.

Job Description:

We are seeking a dedicated and detail-oriented Quality Assurance Engineer to join our team at Nitinotes. The ideal candidate will have 3-5 years of experience in quality assurance within the medical device industry. This role involves ensuring that our products meet the highest standards of quality and safety, maintaining the Quality Management System (QMS), and handling document control according to internal and external regulatory requirements. This role also includes assisting with the execution of verification and validation activities for both new and existing products, as well as supporting the design control review process. It involves providing effective direction and leadership to resolve issues.

Responsibilities:

·        Maintain the QA Management System (QMS) and document control in compliance with internal and external regulatory requirements.

·        Create and manage company documentation control, such as quality procedures, DHF documents, work instructions, and forms.

·        Work closely with functional management and Product Development team to ensure that the requirements of Design development, validation and verification are well managed, well recorded, properly incorporated and executed per the written procedures and requirements.

·        Effectively interact with Production and Engineering teams to maintain product revisions, control and supply.

·        Manage and maintain the finished product release program for the Company.

·        Monitor performance by gathering relevant quality assurance metrics and producing statistical reports.

·        Manage the Design History File (DHF) and Device Master Record (DMR).

·        Manage and participate in MRB and CAPA committee and process, as well as facilitate to the ECO committee and process.

·        Manage the customer complaint/vigilance process interfacing with Product Development and Clinical departments to review complaint investigations and trend such complaints.

·        Enforce compliance with quality system procedures and regulatory requirements through internal and external audits.

Experience and Skills Required:

·        Bachelor’s degree in engineering or a scientific discipline.

·        3-5+ years of experience in Quality Assurance management or Quality Engineering within the biotechnology or medical device industries, specifically in companies with ISO 13485 certified QMS.

·        Good understanding of US and International regulations including 21 CFR, ISO 13485 and MDR 2017/745/EU.

·        experience in root cause analysis and statistical techniques related to problem solving such as cause and effect analysis, pareto analysis (advantageous), process mapping, and other continuous improvement tools.

·        Excellent communication, organizational, and recordkeeping skills.

·        Strong technical writing skills in English.

·        Strong problem solving and project management skills.

·        Ability to work in a fast-paced environment and handle multiple competing tasks and demands simultaneously.

·        Strong ethics with the ability to escalate issues in the face of competing company priorities.

·        Experience working in multi-disciplinary teams.

·        Advantageous: Experience with Quality System Management software for document control and other quality system processes.

·        Advantageous: Experience with Process validation activities.

·        Advantageous: Experience with clean room manufacturing.

How to Apply:

Interested candidates should submit their resume (CV) to [email protected]