Senior Quality Engineer
Vacancy expired!
Immediate need for a talented
Senior Quality Engineer. This is a 12+ Months contract opportunity with long-term potential and is located in Chicago, IL (Hybrid). Please review the job description below and contact me ASAP if you are interested. Job ID: 23-23164 Pay Range: $95 - $101.50/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).Key Responsibilities:- Assists in ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility. Leads, develops, communicates & implements a quality and compliance strategy. Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site.
- Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools, utilizing the Agile/Lean methods and traditional project management methods. Works with engineering teams closely to drive quality excellence of digital medical devices, including design reviews, processes/practices simplification, quality system training, etc.
- Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).
- Utilizes risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. Supports design mitigation efforts. Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process.
- Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
- Minimum of Bachelor's Degree in Engineering, Computer Science or equivalent. Minimum 5 years’ experience in Quality Assurance / Regulatory Affairs.
- Minimum 3 years’ experience in software within a regulated industry.
- Practical knowledge of software development and familiarity with Software Development Lifecycle (SDLC) in medical device or healthcare software development environment.
- Experience with Agile/Lean software development methods. Ability to effectively communicate technical information in English (both written and oral).
- Strong leadership and communication skills. Previous project management experience is preferred.
- Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
- Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management.
- Demonstrated collaboration, negotiation & conflict resolution skills. Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance.
- Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment.
- Experience in a global working environment.
- Experience leading and implementing change. Experience performing internal audits and participating in external audits.
- Exceptional analytical, problem solving & root-cause analysis skills. Ability to multi-task & handle tasks with competing priorities effectively. Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.