Quality Engineer I
Quality Engineer I
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Job Description
Hello
My name is Vaibhav and I am a Recruitment Professional with Select Source International a global staffing agency.
I am reaching out today because I came across your resume on Monster and I believe your experience and skill set would make you an ideal candidate for a Quality Engineer I (Post Market Quality Engineer) role that I am looking to fill in Marlborough MA 01752.
Please review the job description I have provided below and if you are interested reach out to me at: (612). I am available anytime from 8:30 am 5:30 pm CST. You may also reply to this email by providing me with the best contact number and time frame for me to give you a call.
These positions do move fast so time is of the essence. I look forward to hearing from you soon!
Job Title: Quality Engineer I (Post Market Quality Engineer)
Location: 445 Simarano Drive Marlborough MA 01752
Duration: 09 months
Shift: 1st Shift
Summary of Duties and Responsibilities:
- 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 Surveillances 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 riskbased 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 Bachelors degree in engineering or related career.
Experience / Experience:
- No experience required.
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.
Employment Type
Full Time
