Senior Validation Engineer

Senior Validation Engineer

Salary Range : $120,000-$140,000 per year

Qualifications

• Education or Equivalent Experience: Engineering Bachelor's Degree or equivalent
• Experience: 8-10 years Quality Engineering Experience
• Validation Process knowledge
• Medical Device Regulations and standards (ISO 13485, ISO 14791, 21 CFR 820, and 2017/745 (EU/MDR)
• Demonstrate understanding of QC and/or Six Sigma skills such as Control, Run, and Pareto Charts, Histogram, Scatter Plot, Gantt chart, Fishbone Analysis and Process Capability
• Root Cause Analysis proficient
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target

Responsibilities

• Maintain a safe work environment and ensure compliance with quality objectives and policies
• Work with business leads to develop, implement, and maintain programs and enhance solutions for customer base
• Provide quality assurance support to all functions with focus on compliance in accordance with ISO 13485, ISO 14791, 21 CFR 820, and 2017/745 (EU/MDR) requirements
• This role will support the execution of high complexity/impact projects that will impact the Quality of the product and a Compliance improvement significantly throughout the implementation of changes involving supplier related items, validation process, Quality Culture, risk management process improvement, change management, material controls improvement and Quality Control items
• Interface with internal constituents and external regulatory bodies regarding compliance needs as required
• Assist in the preparation of the Management Review meeting presentations on a quarterly basis

If this role is of interest to you, contact to learn more about the role and next steps.