Principal Quality Engineer - Medical Device

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 2022 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 Principal Quality Engineer is responsible for supporting design and sustaining quality related to Medical Devices manufactured by Quanta and its suppliers including but not limited to Corrective and Preventive Actions (CAPA), Supplier Quality, Quality Data and Trending, and other select quality systems.

Key Responsibilities

• Provide Quality Engineering support for sustaining and development projects.
• Support the organization in the investigation of issues in production and investigate product complaints to determine the root cause and recommend appropriate corrective and preventive action to prevent recurrence.
• Provide knowledge from the complaint investigation into the development of new products.
• Perform Risk Analysis including, Fault Tree Analysis (FTA), Human Factors/Usability files, and Failure Mode and Effects Analysis (FMEA) activities.
• Lead/support Risk Management activities.
• Monitoring and developing reliability improvements to existing & new design.
• Maintain quality system information databases as assigned.
• Evaluate quality data and prepare periodic reports to monitor trends.
• Generate, Review and Approve Change requests on behalf of Quality team.
• Process non-conforming material reports.
• Complete activities associated with the formal release of product.
• Develop and implement instructions/methods for inspecting, testing, and evaluating product conformance to specification.
• Responsible for recommending continuous improvement in product quality.
• Perform Quality control inspection and lot release activities for products.
• Ensure any targets set for the business relating to QMS KPIs are monitored and met where appropriate.

Requirements

• BS in Engineering.
• 8+ 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, Canadian 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
• We are only considering candidates local to our Beverly, MA office.

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.