Quality Engineer I
1 day ago
Job Description:
Title:
Quality Engineer I
Location:
Marlborough MA 01752
Job ID:
HOLXJP00001050
Duration:
9 Months (High Chances of Extension)
Summary of Duties and Responsibilities:
This quality engineer is focused on Post Market Quality:
- Assess complaints and assign the applicable complaint failure mode and determine if escalation is required if the event is related to a Potential Adverse Event (PAE).
- Escalate events to the Clinical Specialists and/or PMS Manager when there is any Potential Adverse Event described.
- Testing of returned units from reported complaints.
- Ensure complaint investigation procedures are best in class and aligned with the requirements.
- Close complaints in a timely manner.
- Ensure KPIs are met in accordance with the established goals.
- Review and approve complaint investigations in the QMS, as required.
- Provide input to the organization regarding the information gathered from complaint investigations.
- Support preparation of budget forecasts and ensure compliance with the approved budget.
- Implement tools to ensure laboratory expenses are met in accordance with the approved budget and forecast.
- Innovate processes to improve efficiency and ensure compliance with the Post Market Surveillance s requirements.
- Support Product Transfers.
- Participate, support and/or lead PMS projects
- Support and promote the implementation of EHS programs to ensure staff safety and environmental health.
- Communicate with OEMs and CMs, as needed and send the applicable complaint information to the corresponding vendor.
- Coordinate services with suppliers and availability of the required supplies in house. (as applicable).
- Coordinate and ensure that required payments to vendors are performed on time.
- Make decisions following a risk-based approach, implement tools as FMEA, Fault Tree Analysis (FTA) and risk evaluation.
- Support other facilities and OEMs/CMs, as required.
- Ensure equipment is properly calibrated and controlled with the QMS. Ensure the Preventive Maintenance program is implemented as required.
- Execute investigations such as OOTs, NCEs, CAPAs, IACAs and/or similar. Ensure they are performed on time, in compliance with procedures and regulations.
Qualifications:
- Drive for Results
- Planning
- Organizational Agility
- Listening
- Decision making
- Problem Solving
- Communication
Education:
- University Bachelor's degree in engineering, or related career.
Specialized Knowledge (Desirable)
- FDA regulations (Including the MDR for Manufacturers Guidance), ISO 13485, ISO 14947, EU MDD/MDR and any related ISO and AAMI standards.
- Equipment qualification.
- Laboratory good practices.
- Test method and procedure development
- Statistics
Languages required for the position:
- Native English
- Computer tools and knowledge level required (Desirable)
- Microsoft Office, Internet, Minitab, Oracle, Agile and H1.
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