Quality Engineer

We're searching for a Quality Assurance Engineer who thrives in a regulated, high-precision environment. If you have a keen eye for detail, a passion for medical device compliance, and the ability to drive quality improvements, we want to hear from you.

Responsibilities include:

• Ensuring Compliance: Maintain and enhance the Quality Management System (QMS) to meet ISO 9001-2015, FDA QSR, ISO 13485, and ISO 17025 standards.
• Process Optimization: Create, review, and improve Standard Operating Procedures (SOPs), Work Instructions (WIs), and Form Control Documents (FCDs) to align with regulatory requirements.
• Data-Driven Decision Making: Analyze SPC charts for process parameters, conduct risk assessments (FMEA), and validate internal change management data before product commercialization.
• Auditing & Validation: Lead and participate in internal audits, ensuring compliance with ISO standards and customer requirements.
• Customer Focus: Manage customer complaints, oversee Return Material Authorization (RMA) processes, and lead weekly complaint review meetings (TICS) for resolution tracking.
• Continuous Improvement: Drive Kaizen initiatives, participate in root cause analysis, and contribute to process excellence strategies.
• Training & Leadership: Develop and implement training programs, evaluate competency, and ensure compliance with updated quality protocols.
• Recall Management: Serve as the Recall Coordinator, leading both mock and actual recall activities.

What You Bring to the Table:

• Education: Bachelor's Degree in Applied Mathematics (with statistics), Engineering, or a related field.
• Experience: 2-5 years in quality engineering within the medical device industry or 10+ years in lieu of a degree.
• Technical Skills: Proficiency in Minitab, Excel, Access, PowerPoint, and Word.
• Regulatory Expertise: Hands-on experience with FDA QSR, ISO 13485, and ISO 14971.
• Validation Knowledge: Familiarity with Test Method Validation (TMV), Corrective and Preventive Actions (CAPA), and non-conformance management.
• Leadership & Communication: Ability to collaborate cross-functionally and drive quality initiatives.

What We Offer:

• A dynamic, fast-paced environment where quality is paramount.
• The opportunity to make a direct impact on the safety and effectiveness of medical devices.
• A culture that values continuous improvement and professional development.

If you're ready to elevate your career in quality engineering and make a difference in the medical device industry, apply today!

Equal Opportunity Employer Statement:
We are an equal opportunity employer and do not discriminate based on race, color, religion, sex, national origin, age, disability, or any other protected category. We celebrate diversity and are committed to creating an inclusive environment for all employees.