Getinge · 5 days ago

Sr. Engineer Production Quality

Merrimack, NH

Full-time

Onsite

Senior Level

3+ years exp

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BiotechnologyHealth Care

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Hiring Manager

Debbie Vessey

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Responsibilities

Identify and implement effective process control systems to support product development and manufacturing

Lead in the implementation of assurances, process controls, and CAPA systems

Apply systematic problem-solving methodologies in resolving quality issues

Lead process control and monitoring of CTQ parameters and specifications

Implement product and process improvement methodologies like Six Sigma and Lean Manufacturing

Investigate, resolve, and prevent product and process non-conformances

Qualification

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Quality management systemsComputer skillsMs officeStatistical softwareQuality assuranceProcess validationDesign of experimentsStatistical process controlProtocol/report preparationIso Fda requirementsAnalyticalProblem-solvingAttention to detail

Required

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 (Word/Excel) 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