Job Title: Engineer
Location: 168 Middlesex Turnpike, Burlington, Massachusetts - 01803
Duration: 6+ months (possible extension)
- We are seeking a high caliber Quality Engineer I to conduct complaint investigation management and all activities pertaining to product complaints for Mechanical Circulatory Support devices. This includes, but is not limited to: receiving and investigating reports of worldwide complaints/events; entering information into the complaint database; supporting filing and response to medical devices reports with various regulatory agencies; participating on cross-functional teams; and providing information on product complaints, including data extracted from the complaint database to various teams (e.g. Regulatory, Quality Engineering). This QE 1 role will also have the opportunity to expand development in the area of quality engineering methodologies and providing quality engineering support within new product development, manufacturing, manufacturing transfers, and/or system/services support.
- Communicates verbally and in writing both internally and externally to regarding information needed specific to new product complaints (e.g. physicians, hospital personnel, sales representatives, international offices), initiates and manages the complaint file
- Investigates complaints/events in a timely manner
- Maintains accurate entry of complaints in database
- Records condition of returned products including observations, photographs
- Coordinates product testing/analysis with other departments and external consultants
- Prepares technical reports of analysis/findings
- Tracks returned products within the database, as appropriate.
- Works collaboratively with cross-functional groups (e.g. QEs, R&D) on evaluation trends or findings
- Interprets technical product specifications, Device History Records, or measurements obtained
- Utilizes safe bio-hazard and chemical handling practices at all times
- Participates in cross-functional complaint review groups on a regular basis or as requested (e.g. cross-functional complaint teams, rapid customer response team, Risk Management meetings)
- Leads the investigation, resolution and prevention of product and process nonconformances
- Participates in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
- Leads in the completion and maintenance of risk analysis
- Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Performs other related duties and responsibilities, on occasion, as assigned.
- BS degree in Biomedical or Mechanical Engineering;
- 0-2 years' experience
- Engineering experience preferred
- Knowledge of global regulations for medical device reporting and medical terminology is a plus
- Strong written and oral communication skills are required.
- Candidate must be able to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously.
Thanks & Regards,