Quality Systems Engineer

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Job description

Company Overview

Quanta Dialysis Technologies is a pioneering medical device company entering the US market from the UK. We are on a mission to become the worlds leading provider of self-care solutions for hemodialysis patients, and we are only at the beginning of our story.

The Quanta SC+ is a small, simple, powerful, connected dialysis system designed for use in hospitals, skilled nursing facilities, and patient homes. The company is based in Alcester, UK with the US offices located in Beverly, MA.

We are poised for big things in 2021 and beyond, and this pivotal role will form part of our founding US team and help lay the building blocks for our future success. This is your chance to join a fast-growing company in a newly developed position, where you will have a unique opportunity to make an impact on the growth and development of the team.

Overview
The Quality Systems Engineer is responsible for maintaining the Quality Management System for Quanta Dialysis Technology and support with all Quality compliance related activities, including but not limited to, internal audits, regulatory audits, developing processes and procedures and making sure the organization is compliant with the ISO13485, MDSAP, MDR and other regulatory requirements.

Key Responsibilities

* Provide Quality Systems support for sustaining and development projects.
* Support the organization in developing and updating the Quality Management System (QMS).
* Provide support and leadership in writing Standard Operating Procedures (SOPs) and Work instructions (WIs).
* Support Management review meetings by providing Quality data.
* Generate weekly and other routine reports for Key Process Indicators (KPI) discussion with the Management.
* Maintain quality system information databases as assigned.
* Evaluate quality data and prepare periodic reports to monitor trends.
* Generate, review, and approve Change requests for Quality Assurance.
* Process Corrective and Preventive Actions (CAPAs), Non-conformances (NCs) and Deviations.
* Manage Employee Training matrix and make sure appropriate assignment of training during hiring process.
* Support with Monthly Corrective Action Board meetings.
* Provide guidance and direction to the Quality functions at the various manufacturing facilities which will include supporting CAPA, and Change Control.
* Experience with ISO13485, 21 CFR part 820, ISO9001, MDSAP & MDR requirements.
* Support External Regulatory Audits.
* Perform Internal Audit Schedule and execute Internal Audits.
* Manage Supplier Quality Metrics.
* Support with Supplier Agreements and selection and approval of suppliers to add them to the Approved Supplier List.
* Manage Supplier Audit plans and execution of supplier audits for critical suppliers.
* Process non-conforming material reports
* Ensure any targets set for the business relating to QMS KPIs are monitored and met where appropriate (e.g. NC, CAPA, complaints resolution, self-training etc.).

Requirements

* BS/BA in Engineering or Science preferred
* 3+ years of experience in medical device
* Intermediate knowledge of FDA Medical Device Regulations including Quality System
* Regulation 21 CFR Part 820, and applicable international quality standards including ISO
* 13485, MDR, Medical Device Directive, and ISO14791.
* Strong analytical skills, excellent verbal communication and customer interface skills.
* Ability to interface with multiple groups in the organization.
* ASQ certification is a plus.

EEO Statement

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.