Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

How will you make an impact?

The Quality Assurance (QA) Engineer with demonstrated experience driving and sustaining improvement to quality systems, and ensuring that products manufactured to meet internal, customer, and regulatory requirements. The ideal candidate will strengthen our quality system, promote alignment to Quality Assurance policies and requirements, and drive the execution of quality goals and objectives.

A Day in the Life:

• Expert at QMS Deployment and Systemic Problem Solving, ensuring compliance with ISO9001, ISO13485, FDA 21CFR Part 820 in all systems and procedures
• Manage the internal audit program and support external audit readiness
• Trending and reporting of data
• Facilitate CAPA and investigations
• Manage QMS deviations promptly and ensure reporting of critical issues
• Support New Product Introductions (NPI) by interacting with various teams to ensure product and process compliance
• Support customer complaints resolution and field actions
• Drive continuous improvement across the Organization
• Maintain a culture of high employee engagement, teamwork and flexibility

• Minimum Education Required: Bachelor's degree in Scientific/ Technical field.

• 1-2 years of relevant Quality experience in an ISO 9001, ISO 13485 environment required

• Auditing experience, ASQ CQA or ISO 13485 Lead Auditor or Internal Auditor certifications preferred
• Knowledge of the US FDA Quality System Regulations and ISO 13485
• Knowledge and understanding of Design Control and Risk Management
• Successful with influencing and getting results
• Strong analytical skills and attention to detail
• Self-motivated with the ability to work as part of a team and/or independently
• Excellent verbal and written skills to successfully communicate to a variety of internal and external audiences, while counseling, discussing and formally presenting views and/or technical criteria