Sr Quality Engineer

Sr Quality Engineer

Requirements

• Bachelor’s Degree required; Advanced Degree desirable.
• Minimum 5 – 8 years of related experience; or a Master’s degree with 3 years’ experience.
• Strong analytical & troubleshooting skills.
• Ability to understand and employ mathematics at an engineering or scientific level.
• Strong technical report writing skills.
• Ability to read, analyze, interpret common scientific and technical reports, technical procedures, governmental regulations.
• Experience with Correlation and regression Analysis, Experimental Design (DOE), and acceptance sampling; as well as conducting and interpreting gage R&R studies.
• Strong oral and written communication skills.
• Strong computer skills, proficient with Microsoft Office.

Responsibilities

• Coordinates timely and complete investigations within the assigned manufacturing plant.
• Ensures compliance to all state and Federal regulations and requirements.
• Composes and executes design and process verification and validation protocols and reports. Reviews and approves protocols and reports written by other staff as appropriate.
• Investigates root cause solutions for product release through nonconformance reports (NCR), corrective and preventative actions (CAPA), and material containment and hold forms (MCH) and affected lot hold forms (ALH).
• Utilizes basic statistical techniques, Experimental Design (DOE), Risk Management, Hazard Analysis and Critical Control Point (HACCP), and Failure Modes and Effects Analysis (FMEA). Conducts and interprets Gage Reproducibility and Repeatability (R&R) studies.
• Provides support in coordinating plant risk management activities and ensuring risk management techniques are implemented throughout product lifecycle.
• May provide assistance to junior level staff with more complex tasks that require a higher level of understanding of functions.
• May escalate issues to supervisor/manager for resolution, as deemed necessary.
• May manage and execute testing and release procedures for finished products.
• Mentors other staff as applicable.
• Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
• Assists with various projects as assigned by a direct supervisor.
• Other duties as assigned.

Preferred Qualifications

• Advanced Degree desirable.

Benefits

No information provided on Benefits.