SENIOR QUALITY ASSURANCE ENGINEER

COMPANY OVERVIEW

We are MedAcuity, Inc. We partner with leading product development companies to develop life and mission-critical software bringing the highest levels of *Service* and *Value* to every engagement. Through our consulting and development engagements, we bring the best and brightest talent to our clients, applying deep technical knowledge, business acumen, and innovative solutions to complex engineering problems and constructing aligned solutions for our clients. Our approach forges long-term, collaborative relationships with clients enabling them to focus on their own core competencies in Medical Devices, Robotics, and Aerospace / Defense Equipment.

JOB SUMMARY

The Senior Quality Assurance Engineer will work closely with internal and external project teams, cross-functionally throughout the project life cycle primarily in the MedTech space. The candidate will be adept at remediating legacy quality systems, and ensuring consistent, compliant project execution. They will be responsible for auditing processes, developing and improving QMS procedures, and ensuring alignment with regulatory and industry standards.

RESPONSIBILITIES

• Contribute to or lead assessment engagements for medical device products in terms of completeness, conformance, and compliance as it relates to a Quality Management System (QMS) and associated QMS elements and Design and Development File and associated design artifacts.
• Author, remediate, and improve QMS elements including SOPs and Wis as well as project specific documents such as Quality Management Plans, Verification and Validation Plans, Risk Management Plans, and CAPAs.
• Partner with project teams and clients to ensure conformance to requirements of 21 CFR Part 820, ISO 13485 with particular focus on Design Controls, Risk Management (per ISO 14971), Production, Service Controls, Product Privacy, and Security.
• Provide teams with technical support for QA / Regulatory compliance activities