Job Title: Validation Engineer
Reports To: VP Engineering & Technology
FLSA Status: Exempt
Direct Reports: No

Position Summary:

The Quality Validation Engineer will be responsible for planning and completion component and assembly process validations of processes per Beacon MedTech Quality System, Customer Requirements, FDA regulations and ISO standards.  Familiar with standard concepts, practices and procedures for compliance purposes.  Relies on experience and judgment to plan and accomplish goals.  Works independently with minimal supervision.

Essential Functions/Responsibilities:

• Directs equipment/process and assembly validation IQ’s, OQ’s & PQs for adherence to FDA regulations through development of the Master Validation Plan (MVP).
• Write and execute validation protocols and reports for equipment and process operations using GMP (Good Manufacturing Practices).
• Analyze and complete capability data (PpK, CpK, Normality, etc.) in Minitab.
• Use engineering or scientific knowledge to understand the technical aspects of validation to create test strategies consistent with the operational and compliance needs.
• Participate in risk analysis and ensure the risk mitigations are properly implemented
• Provide technical support to manufacturing, customers, and others as needed
• Reviews and dispositions nonconforming materials.
• Assists in the monitoring and improvement scrap and rework.
• Reviews and dispositions nonconforming materials.
• Assists in the monitoring and improvement scrap and rework.
• Leads validation training requirements for validation with Document Control and Training Supervisor.
• Investigates CAPA’s, determines root causes, corrective actions and follow through.
• Assists the Supplier Quality Engineer (SQE) with supplier validation activities.
• Assist in other Quality and Manufacturing Engineering duties as needed.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements and work conditions, including physical demands, listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

Knowledge/Skills/Abilities:

• Knowledge and experience in injection molding, assembly, and validation of medical or life science products.
• Regulatory cGMP, QSR and ISO knowledge base
• Strong statistical skills and experience with Process Capability, Reliability, Gage R&R, DOEs, in Minitab.
• Computer literate/proficient with Microsoft Office applications
• Negotiation and problem-solving skills
• Good oral and written communication skills; ability to properly speak and write in the English language
• Experience in manufacturing operations
• Ability to multi-task, prioritize and work independentl

Education/Experience:

• 3-10 years experience in an injection molding and assembly environment
• Experience in a regulated environment, preferably medical device (ISO 13485