Quality Engineer I

1 day ago


Marlborough, United States SGS Consulting Full time

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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