NPI Quality Engineer

About the role

We are seeking a NPI Quality Engineer to join our team supporting New Product Introduction in Jaffrey, NH. The 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.

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.
• Write and approve validation protocols and reports, create and update SOPs and test methods, and perform data analysis and trending to monitor product quality and process performance.
• Provide guidance for the disposition of non-conforming product and raw materials, including 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 with 3+ years of Quality Engineering experience or similar technical role in a regulated manufacturing environment.
• Master’s degree in Mechanical Engineering, Chemical Engineering, Industrial Engineering, or other Engineering discipline with 5+ years of Quality Engineering experience in an FDA regulated (pharmaceutical, biotechnology, or medical device) manufacturing setting with a proven track record of successful performance.

Preferred Qualifications

• 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/preventive 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").

Pay

The pay range for this position is $80,000.00 - $138,100.00 annually. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses.

Benefits

Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.