We are a dynamic group of professionals providing regulatory, quality and clinical services for the medical device industry. Our team supports start-ups, mid-sized private companies and large corporations at all stages of the product life cycle. We work across a broad spectrum of technologies and treatment modalities; our clients develop both next generation and paradigm shifting devices. Our product exposure includes implantables, instruments (manual, laser, robotic, etc.), capital equipment, combination products, software as a medical device (SaMD), medical apps, in vitro diagnostics and more.
We are seeking a Quality Engineer to support our senior Quality team. The Quality Engineer will organize and manage the Quality activities for companies to help them identify and meet their Quality Management System needs. Additionally, the Quality Engineer will evaluate design outputs for quality requirements and establish quality, risk, or other management plans for equipment and processes for general and specific product performance needs. These activities must be in accordance with industry standards testing, FDA Quality System Regulation, ISO 13485, ISO 14971, the EU Medical Device Directive and the EU Medica Devices Regulation.
MAJOR DUTIES OF POSITION:
- Perform device design control and quality engineering activities. This will include working with outside clients to complete design control activities.
- Support cross-functional teams in developing and executing Verification and Validation Plans, including writing and executing related protocols and reports.
- Provide Risk Management expertise in the evaluation and design of product, design validation and verification, complaint and nonconforming materials investigations and implementation of corrective and preventive action (CAPA), as required.
- Hold responsibility for applying appropriate design controls, manufacturing controls, quality assurance techniques and controls, and statistical controls and methodology throughout the life cycle for respective products.
- Maintain accountability for project timelines and deliverables to both internal and external management.
- Facilitate the documentation of risk management using industry standard tools including FMEAs and Fault Tree Analysis for systems, subsystems, manufacturing processes and clinical workflows to ISO 14971.
- Drive risk mitigation, including verification of risk mitigations, through design and product requirement definitions.
- Ensure completion and documentation of verification and validation activities, including traceability to requirements in compliance with applicable quality system regulations.
- Provide input and/or oversight for other quality system related activities, including complaint handling, CAPA investigation and supplier evaluations, as needed to assist clients in ensuring product quality and proper implementation of compliant processes.
KNOWLEDGE AND SKILL REQUIREMENTS:
- Bachelor degree in Engineering or Life Sciences required, master’s degree preferred.
- Minimum 2 years’ experience preferred, will consider applicants with more senior experience
- High attention to detail and project management skills a must.
- Knowledge of medical device regulations and standards (i.e., QSR, ISO 13485, ISO 14971, ISO 60601 series, ISO 62304, ISO 10993 series, ISO 11135, and ISO 11137) required.
- Experience in a full product life cycle, including definition of customer needs, development, design testing, design transfer, manufacturing scale up, distribution, service and post market analysis is critical.
- Sound understanding of concepts and principles of Quality Assurance with respect to new product development, regulatory bodies, external suppliers, product manufacturing and product servicing is necessary.
- Excellent verbal and writing skills are required.
- Medical, Dental and Vision Benefits
- 18 Days of Paid Time-Off (PTO)
- 11 Paid Holidays
The above description is intended to describe the general content, identify the essential functions of, and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.