Sr Quality Engineer

About the Role

Coordinates all efforts for major projects and other significant assignments. Assists in performing disciplined problem solving for supplier, customer, and internal quality defects. Plays an active role in supporting design control activities, from concept through release.

Responsibilities

• Coordinates timely and complete investigations within the assigned manufacturing plant.
• Ensures compliance with 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 ensures risk management techniques are implemented throughout the 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.

Engineer/CAPA Focus

• Manages the analysis of CAPA trends and other areas of plant quality data on a periodic basis.
• Ensures that the CAPA procedures are clearly defined and implemented to fulfill regulatory and business requirements.
• Identifies areas for continuous improvement of these procedures.
• Ensures all CAPA files are maintained.
• Coordinates timely and complete CAPA investigations within the assigned manufacturing plant.
• Provides direction and guidance to plant employees with CAPA responsibilities.
• Leads and trains plant personnel on CAPA.
• Maintains current SOPs related to plant CAPA processes and procedures.
• Analyzes and reports on CAPA trends and other areas of quality data on a periodic basis.

Engineer/Quality Management Focus

• Ensures that the Supplier Management procedures are clearly defined and implemented to fulfill regulatory and business requirements.
• Identifies areas for continuous improvement of these procedures.
• Ensures all Supplier files are maintained.
• Assists in providing in-house training (e.g., calibration, validations, GDP) in conjunction with plant management to operations and other personnel as assigned.
• Participates as a member of the facility’s Audit Team in performing internal and external audits as required.
• Uses appropriate statistical methodology, such as CpK and trend analysis, to assist in analyzing or reviewing manufacturing, quality, and/or laboratory data for recurring problems or the detection of trends.
• Establishes reports and procedures in conjunction with Process Engineering to assure system reliability and product quality.
• Recommends corrective action for problem resolution when recurring problems and/or negative trends are identified.
• Ensures all CAPA files are maintained.
• Coordinates timely and complete CAPA investigations within the assigned manufacturing plant.

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 and troubleshooting skills.
• Ability to understand and employ mathematics at an engineering or scientific level.
• Strong technical report writing skills.
• Ability to read, analyze, and interpret common scientific and technical reports, technical procedures, and 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.

Physical Demands and Working Conditions

• Ability to lift up to 50 lbs. as required.
• The employee may be exposed to bovine and human blood products. Hepatitis B Vaccination is recommended.