SQE

Job title: SQE

Location: North Haven CT (Onsite)

Job Summary: Join our team as a Software Quality Engineer (SQE) in North Haven CT! Were looking for a detailoriented professional to actively participate in our product development cycle manage risk and ensure highquality standards for our mechanical medical devices.

Key Responsibilities:

• Review project documentation and participate in risk assessments.
• Develop and facilitate risk management tools (e.g. risk management reports FMEAs).
• Collect analyze and interpret statistical data; report findings to management.
• Facilitate process validation initiatives and related qualification activities.
• Collaborate with crossfunctional teams to track timelines and deliver Quality Engineering outputs.
• Provide support to other quality groups and develop innovative solutions to complex challenges.
• Guide the implementation of risk management standards in new product development.

Required Skills:

• Experience in product development and quality engineering.
• Proficiency in statistical data analysis.
• Familiarity with risk management tools and process validation.
• Strong problemsolving skills and ability to work independently.
• Excellent communication and collaboration abilities.
• Knowledge of risk management standards for mechanical medical devices.