In this role, you have the opportunity to
Develop and implement systems to ensure products or services are designed and produced to meet or exceed customer and regulatory requirements-expectations. Establish the principles of product and service quality evaluation and control for the system.
You are responsible for
- Provides quality engineering insight/ guidance on global compliance, such as CE Marking and product registrations, clinical evaluations, post market surveillance in accordance with MDD Annex X & ISO 14155, Canada Medical Device Regulations, etc.
- Knowledge of the nature and impact that the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) will have on Manufacturers, Notified Bodies, existing products in the EU regions, documentation and other aspects of medical device.
- Develop and implement quality programs, including tracking, analyzing, reporting, and problem solving.
- Provides effective oversight to the execution of the Quality Plan, Risk Management activities and post market surveillance activities.
- Validates key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs.
- Plan, control, and assure product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling, and measurement systems.
- Plan, control, and assure product application, including design, manufacturing and construction.
- Have knowledge of reliability, maintainability, and risk management, including key terms and definitions, modeling, systems design, assessment tools, and reporting.
- Have understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.
- Understanding of the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up.
- Acquire and analyze data using appropriate standard quantitative methods across a spectrum of business environments to facilitate process analysis and improvements.
- Develop inspection and test strategies.
- Reviews and assists in the development of verification and validation protocols and reports and identifies gaps for compliance with internal processes.
- Author validation, verification, and inspection assessments to ensure the defensibility of product test data. Selects appropriate testing sample sizes based on criticality and statistical calculation.
- Participates on teams to ensure robust application of appropriate design and manufacturing controls.
- Supports leadership to ensure quality and completeness of project design history files, risk management files, validation packages, and change orders.
- Provides ongoing quality engineering support throughout the product lifecycle, including risk management, design and manufacturing changes, and CAPA investigations.
- Engages in continuous improvement activities by identifying opportunities and recommending improvements to design and development process.
To succeed in this role, you should have the following skills and experience
- Strong working knowledge of medical device regulations (21CFR), MDD, MDR, other global laws and regulations and standards including ISO14971, IEC 60601 and related particular standards.
- Knowledge of the nature and impact that the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) will have on Manufacturers and Notified Bodies.
- Engineering Degree or equivalent experience in medical device industry.
- At least 5 years’ experience in with Medical Devices.
- ASQ certified Quality Engineer is a plus.
- Understand risk analysis philosophies, methodologies, and their applications.
- Have a working understanding of LEAN and six sigma concepts, methodologies and deployment.
- Be able to make tough, decisive decisions concerning the containment and disposition of product quality and product safety issues.
- Have an understanding of problem-solving and quality improvement tools and techniques
- This role may require 10-15% travelling.