NPI Quality Engineer

Merck•Jaffrey, NH

3d•Onsite

About The Position

We are seeking a NPI Quality Engineer to join our team supporting New Product Introduction in Jaffrey, NH. The world-class Jaffrey Manufacturing Center of Excellence is ISO 9001 and ISO 14001 Certified, practices Six Sigma principles and is an environmentally conscious facility focused on long term sustainability. Collaborate with Product Development and Product Management on the introduction of new products and/or line extensions into the Jaffrey facility. Provide Quality Engineering guidance and support for device manufacturing as a liaison between product development and the plant. Lead and participate in the creation of risk assessments (e.g. product and process-FMEA). Provide guidance and support for product validations and equipment qualifications including establishing acceptance criteria, sampling plans and performing data analysis. Writes and approves validation protocols and reports, creates and updates SOPs and test methods, and performs data analysis and trending to monitor product quality and process performance. Provide guidance for the disposition of non-conforming product and raw materials. This includes the evaluation of deviations / out of specification conditions, data trending, and leading quality investigations (root cause analysis and corrective action plans) Provide guidance and support for shelf-life studies both accelerated and real-time aging including protocol creation, sample submission, data analysis, out of specification investigation, and report creation.

Requirements

Bachelor of Science degree in Mechanical Engineering, Chemical Engineering, Industrial Engineering or other technical discipline
3+ years of Quality Engineering experience or similar technical role in a regulated manufacturing environment
Working Knowledge of ISO 9001:2015 requirements

Nice To Haves

Master’s degree in Mechanical Engineering, Chemical Engineering Industrial Engineering or other Engineering discipline.
5+ years of Quality Engineering experience in an FDA regulated (pharmaceutical, biotechnology, or medical device) manufacturing setting with proven track record of successful performance.
Strong communication skills with the ability to collaborate at all levels and functions of the organization and with customers.
Operate in a complex, matrixed, and fast paced environment and gain consensus with groups
Validation experience in a regulated manufacturing industry.
Conduct quality investigations including root cause analysis and determining corrective / preventative actions.
Pragmatic risk-based decision maker with strong problem-solving ability.
Collaborative team player with experience using data analysis tools such as Minitab, electronic quality systems (CAPA, Change Control, and Document Management), and continuous improvement methodologies, including ASQ Certified Quality Engineer (CQE) and Six Sigma Green Belt/Black Belt practices.
Demonstrated ability to create and update standard operating procedures ("SOP")

Responsibilities

Collaborate with Product Development and Product Management on the introduction of new products and/or line extensions into the Jaffrey facility.
Provide Quality Engineering guidance and support for device manufacturing as a liaison between product development and the plant.
Lead and participate in the creation of risk assessments (e.g. product and process-FMEA).
Provide guidance and support for product validations and equipment qualifications including establishing acceptance criteria, sampling plans and performing data analysis.
Writes and approves validation protocols and reports, creates and updates SOPs and test methods, and performs data analysis and trending to monitor product quality and process performance.
Provide guidance for the disposition of non-conforming product and raw materials.
Evaluate deviations / out of specification conditions, data trending, and leading quality investigations (root cause analysis and corrective action plans).
Provide guidance and support for shelf-life studies both accelerated and real-time aging including protocol creation, sample submission, data analysis, out of specification investigation, and report creation.