Validation / Continuous Improvement Engineer

Reports to: QA Director

BASIC FUNCTION

This position resides in the Quality Engineering Department with dual responsibility for equipment, software and process validation as well as supporting continuous improvement activities for contract-manufactured orthopedic medical devices.

MAJOR RESPONSIBILITIES

1. Serve as the primary validation engineer with responsibility for ensuring all equipment and manufacturing processes are qualified and validated to internal, external and industry standards.
2. Establishes all aspects of a validation project; including: authoring/reviewing/executing Validation Master Plan (VMP) and Procedure, Validation Plan (VP), User Requirements Specifications (URS), Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols/report, risk assessments, and periodic validation/qualification reviews.
3. Develops the Company’s validation plan and strategy, execution and implementation. Creates and maintains a current validation schedule. Submits reports regarding scope and status of validation activity.

4. Analyzes information and draws conclusions based upon technical knowledge of the systems. Works with different groups/departments to ensure correct interpretation and execution of information and protocols.
5. Coordinates validation activities between the PPM team, Customers and Suppliers.
6. Work with facilities, operations, engineering, purchasing, etc. in the development, execution and change control of validation protocols.
7. Maintain up-to-date knowledge of validation requirements, practices, and procedures. Coaches other members of the team participating in validation activities.
8. Also, support continuous improvement and lean initiatives to identify and drive out waste from current manufacturing processes while maintaining the highest level of quality.

JOB REQUIREMENTS

Education:

BS in Mechanical Engineering or equivalent, Master’s degree a plus.

Qualifications and Skills:

• Minimum of 3 years’ experience writing and executing validation documents, IQ/OQ/PQ protocols.
• Familiarity with Good Manufacturing Practices, as well as Lean Manufacturing/Six Sigma.
• Experience with both conventional CNC and robotic manufacturing processes.
• Good understanding of measurement system analysis including GR&R.
• Ability to use statistical techniques using MiniTab
• Formal Six Sigma training, Green or Black belt certification a plus.
• Previous experience working in a highly regulated environment is a must – Understanding of ISO 13485 and FDA 21 CFR part 820 preferred.
• Must be dynamic and mobile individual capable of clearly communicating with customers and plant personnel at all levels.
• Strong ability to generate technical detailed written reports as required.
• Excellent organizational skills, with the ability to handle multiple priorities and deadlines.
• Proficiency with various software programs; including word processing, spreadsheet and database applications.