Sr. Engineer, Production Quality Engineering

Getinge•Merrimack, NH

7d•$95,000 - $120,000

About The Position

The Sr. Engineer, Quality Operations is responsible for understanding quality requirements, developing and improving processes to meet those requirements, driving internal efforts for root cause analysis and corrective actions, while providing day to day support of processes to meet our high standards of precision and quality in producing medical devices. In this role you will be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support to production.

Requirements

Bachelor’s Degree in Engineering or Science, or equivalent work experience.
A minimum of 3-4 years of Quality Management Systems (QMS) experience.
Good analytical and problem-solving skills.
High level of attention to detail and accuracy.
Strong computer skills, including MS Office applications and statistical software are required.
Knowledge of Quality Assurance methods, such as process validation, design of experiments, statistical process control (SPC) and protocol/report preparation.
Knowledge of ISO 13485 and FDA requirements

Responsibilities

Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Lead process control and monitoring of CTQ parameters and specifications
Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
Lead the investigation, resolution and prevention of product and process non-conformances
Lead in the completion and maintenance of risk analysis