Quality Engineer I # JN -062021-66213
Title : Quality Engineer I
Location : Burlington MA
Duration : 6 months contract
- Communicates verbally and in writing both internally and externally to client 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).
- Lead the investigation, resolution and prevention of product and process nonconformances.
- Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
- Lead in the completion and maintenance of risk analysis.
- Support 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 Electrical 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.
- Advanced computer skills, including statistical/data analysis and report writing skills.
- Experience working in a broader enterprise/cross-division business unit model preferred.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Advanced degree.
- Prior medical device experience.
- Knowledge of FDA, GMP, ISO 13485, and ISO 14971.
- ASQ CQE or other related certifications.