When you can´t breathe, nothing else matters.
Our vision at Breas is to provide innovative solutions that enable people with chronic respiratory conditions to live life to the fullest.
We are looking for a Sr. Quality Engineer who wants to make an impact and change the world of ventilation for the better.
At Breas Medical, you will get the chance to work on projects of high importance that improve our end users quality of life. Working at Breas Medical will most likely be a new, impactful chapter of your life, and be a great opportunity for growth.
As one of our key talents, you will be joining Breas at a very exciting stage of our journey. We have just launched two new product series within our Vivo range, with a total of seven new ventilator products. These new products enable us in our strive to be our customers preferred choice and the global market leader within the mechanical ventilator product segment.
This exciting position is within our QA/RA department based at the Breas, N. Billerica, MA office. Breas Medical is owned by the Chinese healthcare group Fosun Pharmaceutical (Group) Co., Ltd. that is traded on the Hong Kong stock exchange.
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Responsibilities include:
- Implement the company’s electronic Quality Management System and maintain its effectiveness for the site, including analysis and implementation of new and changed regulatory requirements. This applies to Breas Medical’s Quality Management System (compliant with MDR, MDSAP,ISO 13485, QSR) and additional requirements per Breas Medical’s business plan;
- Perform training in quality assurance processes and promote the awareness of quality and regulatory requirements;
- Monitor the effectiveness of the Quality Management System and report the status to management on monthly and quarterly basis, as well as forwarding information about other significant effectiveness issues or changes to the QMS upon awareness;
- Conduct investigations of Complaints and Serious Incidents / Adverse Events;
- Analyse and trend complaints;
- Conduct Recalls/Notifications and file Medical Device Reports
- Initiate and lead investigations and actions to critical product nonconformities and process / QMS nonconformities, corrective and preventive action (CAPA).
- Conduct internal audits as well as supplier audits.
- Implement and support with quality assurance processes including process and software validation, calibration and incoming inspection (IQC).
- Host and coordinate external audits;
- Implement company initiatives with direction from senior management.
Decision making Authority:
- Initiate nonconformities and investigations, and facilitate or implement corrections, corrective actions and preventive actions as appropriate to ensure safe and effective products compliance to applicable regulations and standards.
- Ensure regulatory compliance to quality system procedures relating to CAPA, non conformances, complaint handling, supplier auditing, adverse event reporting and product field actions (including Recalls, Notification, etc.) through development, maintenance and adherence to documented processes.
- Release product from manufacturing based on the completion of Device History Records.
- Initiate product (ship) hold when incompliance is identified/ suspected on marketed medical devices.
- Release product under concession following due investigation and justification of impact after the approval of concession by management.
- Conduct complaint investigations.
- Conduct supplier quality system qualifications as per Breas procedures.
- Approve controlled documents per Document Review and Approval Matrix.
- Represent Breas in contact with regulatory authorities (e.g. competent authorities and notified bodies) on matters related to quality assurance.
- Act in the role as QA representative in assigned projects and processes
- Maintain awareness of and comply with the Quality Management System, Quality Policy, Quality Goals, and applicable laws and regulations
- QA representative for nonconformities and CAPA initiated at the site.
- Prepare, review and approve documents as per document approval matrix.
- Identify and report any critical quality or compliance concerns to management and take immediate corrective action as required
- Maintain up-to-date knowledge and understanding of current quality assurance requirements within area of responsibility
- Work closely with Risk Manager, Clinical Affairs Manager and subject matter experts, and document and communicate the conclusions of assessments and investigations.
- Perform (i.e. schedule, conduct and report) internal audits.
- Perform (i.e. schedule, conduct and report) trending of KPI and other indicators.
- Prepare for and host external audits.
- Monitor complaints and investigate potential adverse events.
- Represent QA in Operations management and monitor and support with quality assurance activities, including process and software validation, calibration, nonconformity handling.
- Monitor status and progress of ongoing nonconformities and CAPA, and escalate lack of progress.
Requirements:
- 4-6 years QA Experience
- Bachelor's Degree
- Medical Device preferred
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