Process Validation Engineer (Medical Devices)

Technical Functional Skills:

Experience supporting medical device manufacturing

Process Validations

Specific experience with process characterization, equipment IQOQ, process OQ, and PQ

Specific experience with Test method Validation and Gage RRExperience with root cause analysis and problem-solving for both technical and process issues

Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485-2003

Ability to lead and prioritize multiple medium-complexity project assignments and complete work in a timely manner

Good problem-solving skills using quality and statistical toolsBOM Router creation and update

Ability to read and understand engineering drawings

Knowledge of basic quality tools, risk analysis (PFMEA), statistics (SPC), Critical-to Quality (CTQ)

Analysis Knowledge of Quality System requirements, ISO and FDA requirements

Ability to effectively work within a cross-functional team to complete critical project tasks

Demonstrates good written and verbal communication skillsExperienced with control procedures, such as the Change Management System, Nonconformance Reports, Engineering Specifications, Corrective and Preventive Action (CAPA), and Work Instructions Proficient with Statistical Process Control concepts

Microsoft Office Suite and Project



Experience Required:

4 - 6 years



Roles Responsibilities:

Develops and Executes Process Validation Strategies Creates plans, protocols (IQ, OQ, PQ), and risk assessments to ensure effective processes for medical devices and equipment.Ensures Regulatory Compliance Adheres to FDA (21 CFR 820), ISO 13485, and other relevant regulations, participating in audits and maintaining up-to-date knowledge.Analyzes Data and Reports Findings Compiles and analyzes validation data, writes comprehensive reports, and identifies trends for process improvement.

Collaborates Cross-Functionally Works with Manufacturing, Quality Assurance, Engineering, and other teams to implement cleaning strategies, resolve issues, and provide technical support.

Leads continuous improvement initiatives, manages change controls, troubleshoots cleaning problems, and ensures proper documentation and training.

Creating, maintaining, and improving controlled technical documents such as prints, procedures, bills of materials, and routers.

Supporting a wide variety of processing applications such as machining, finishing, forging, casting, cleaning, heat treating, bonding, molding, etc.

Conducting feasibility study to estimate a product cost and analyze capital equipment, capacity, and capability requirements

Establishing and improving process methods that meet performance and quality requirements

Developing and executing project plans and schedules for work activities

Communicate (written and verbal) direction and project plans with appropriate personnel from other departments.

Evaluating multiple options to select the most appropriate processes and machining methodsExecute equipment qualification or process validation project(s)