Quality Engineer I

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.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.