Salary Range: $120,000-$140,000 per year
Qualifications
- Education or Equivalent Experience: Engineering Bachelor's Degree or equivalent
- Experience: 8-10yrs 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 adam.tizabi@epmscientific to learn more about the role and next steps.
