DESCRIPTION
How will you make an impact?
As a Quality Engineer, II, you will be responsible for facilitating the Investigation and CAPA process to enable the site to reduce the number of customer complaints, improve timeline management by effective investigational work, identifying true root cause and the generation of robust corrective and preventative actions. You will partner with the operations and engineering teams to support the facilitation of investigations and provide input to Critical to Quality (CTQ) parameters to support overall site improvement efforts.
What will you do?
- Provide quality support for issues requiring impact assessment, root cause analysis, identification of appropriate corrective actions, implementation of CAPA plan and monitoring of effectiveness
- Work directly with investigation teams on critical quality issues
- Facilitate investigation activities related to process/product deviations and out of specification conditions by applying various root cause analysis (RCA) methods and tools such as Cause and Effect Diagrams, 5-Whys…etc.
- Implement corrective and preventative actions (CAPAs) to prevent recurrence of deviations and nonconformances. Verify effectiveness of implemented changes utilizing the proper quality tools.
- Perform statistical analysis to track report data to support the site (e.g. CAPA, Right First Time)
- Contribute to continual process improvement by participating in Kaizens, Gemba tours and site projects.
- Support activities within the Quality Management System as required
REQUIREMENTS
How will you get here?
Education:
- Bachelor of Science (BS) from accredited college/university or equivalent experience. Preferred Science or Engineering Degree
Experience:
- Minimum of 2 years of relevant Quality/manufacturing/engineering experience in a regulated industry
Knowledge, Skills, Abilities:
- Accomplished written, oral and presentational skills
- Must be comfortable working as a team member (multi-functional)
- Have excellent interpersonal, time management, decision-making and conflict management skills
- Good data analysis skills, with an ability to use statistical methods to conduct quality investigations.
- Comfortable in conversing at all levels within the organization
- Ability to perform multiple tasks
- General knowledge of ISO 13485 standards and/or FDA cGMP regulations (i.e 21 CFR 820).
- Computer skills: knowledge of Microsoft Office applications (Work, Excel and PowerPoint) is a must. Knowledge of a statistics data software (Minitab, JMP…etc) is highly desirable. Knowledge of TrackWise CAPA Management System is a plus.
- Must maintain high ethical standards to support a professional business code of conduct
Location: Bedford, MA
