Quality Engineer
FluidAI
Quality Assurance
Kitchener, ON, Canada
Posted on Oct 8, 2024
Company Description:
FluidAI Medical is creating a paradigm shift in post-operative care, utilizing the plethora of data within the body to help in the detection of post-operative complications at their onset. Our clinically validated platform sensing technology augments existing wound drains and catheters, providing healthcare providers with a smart monitoring tool that can support earlier detection of deadly complications and enhance the delivery of care.
We are an equal opportunity employer and have a diverse team representation across language, ethnicity, gender, and nationality.
Why Join FluidAI Medical?
- Mission to save lives and improve patient care with technology that’s already deployed on patients in real-world settings.
- Work with a high-performing and cross-functional team that is empowered to grow, learn, and contribute across all levels of the organization.
- Personal career-focused development and training with access to workshops, coursework, and experienced mentors/consultants.
- Regular offsite activities – past events include rafting, axe-throwing, sports leagues, and regular BBQs.
Job Summary:
Are you a self-driven person who believes in continual improvement? Do you enjoy working in a fast-paced, technical environment with new and interesting challenges every day? Are you passionate about Quality and delivering life-changing medical devices? If any of these sound like you, read on!
We are looking to add a Quality Engineer to our high-performing QA and Design/Development team. As a Quality Engineer at FluidAI Medical, you will work closely with the QA/RA Manager and the technical team in the development, implementation, and operation of the Quality System for the control of FluidAI Medical’s medical devices. You will be responsible for the creation and implementation of various Quality Systems processes, driving the continual improvement of our Quality Management System.
This position requires you to come into our Kitchener, ON office at least 50% of the time.
Job Responsibilities:
- Accountable for proper linkage of Design Controls in all stages of the production lifecycle.
- Ensure product, material, and process specifications are fully defined, unambiguous, and practical for the production environment.
- Create test method documents and strategies for existing and new products.
- Plan, execute, and analyze test method/process validations for existing and new products.
- Lead and support component/product inspection and qualification activities.
- Support identification, development, auditing, and onboarding of new suppliers to ensure compliance and business continuity.
- Conduct knowledge transfer activities by training appropriate team members as needed.
- Support the development of process control and monitoring to ensure effective process transfer activities.
- Support quality activities during Post Launch Monitoring.
- Lead investigation and on-time closure of non-conformances, corrective & preventive actions.
- Create process risk documentation and ensure all Risk Management outputs comply with ISO 14971 for Regulatory Submissions.
- Evaluate process risks and ensure appropriate production/process controls are implemented throughout the product lifecycle.
- Maintain process controls to ensure ongoing product compliance.
- Collaborate with Subject Matter Experts on process validation activities to ensure consistent, repeatable, and effective processes are implemented during design and manufacturing transfer.
- Ensure all testing plans have strong statistical rationale.
- Support the creation of Device Master Records.
- Monitor production processes to ensure Quality System compliance.
- Maintain production change control and Quality System compliance.
- Be a champion of our Quality System.
Qualifications:
- Bachelor’s Degree in engineering or a science-related field.
- 2-5 years of experience working in a highly regulated environment.
- Familiarity with ISO13485:2016, ISO 14971, IEC 60601-1:2005, and other relevant standards.
- Strong knowledge of Quality Concepts.
- Strong project management skills and the ability to multitask effectively.
- Demonstrated ability to advocate for product excellence and quality.
- Strong analytical skills with practical knowledge of statistical methods.
- Ability to work independently.
- Highly developed problem-solving skills.
- Ability to work cross-functionally with departments such as Operations, Product Development, Regulatory Affairs, and Marketing.
- Strong interpersonal, written, oral communication, and negotiation skills.
- Familiarity with cGMP.
- Experience interacting with regulatory agencies (FDA, Health Canada, etc.) and Auditing Organizations/Testing Laboratories (TUV, Intertek, Nemko, etc.).
Preferred Qualifications:
- MASc or MS.
- CQE or CRE certifications.
- Familiarity with Six Sigma and/or Lean manufacturing.
- Experience with the medical device product development lifecycle (risk management, design/process verification, and validation).
- Applied knowledge of Advanced Quality tools (FMEA, GD&T, Root Cause Analysis, Mistake Proofing/Poka Yoke).
- Ability to read and interpret CAD drawings.
- Thorough knowledge of Canadian, US, and International Medical Device Regulations.
- Experience working in compliance risk situations.
- Familiarity with Fusion360 or other CAD tools.
- Familiarity with Python or similar programming languages.