Quality Engineer – Full Time | Permanent
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 NERv, you will be working closely with the QA/RA manager as well as the tech team in the development, implementation, and operation of the Quality System for control of NERv’s medical devices. You will also be expected to own the creation and implementation of various Quality Systems processes in addition to driving the continual improvement of our Quality Management System.
This position will require you to come into our Kitchener, ON offices for at least 50% of the time.
- Accountable for proper linkage of Design Controls in all stages of the production lifecycle.
- Accountable for ensuring that product, material, and process specifications are fully defined, unambiguous, and practical for the production environment.
- Creation of test method documents and strategies for existing and new products.\
- Planning, execution, and analysis of test method/process validations for existing and new products.
- Lead and support component/product inspection and qualification activities.
- Support the 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 process monitoring to assure effectiveness of 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 ensures appropriate production/process controls are identified, qualified, and implemented throughout the product manufacturing lifecycle.
- Support maintenance of process controls to ensure ongoing product compliance.
- Collaborates with Subject Matter Experts on all process validation activities to ensure consistent, repeatable, and effective processes are implemented during design and manufacturing transfer.
- Ensure that all testing plans have strong statistical rationale.
- Support the creation of Device Master Records.
- Monitor production process to ensure Quality System Compliance.
- Maintain production change control and Quality System Compliance.
- Be a champion of our Quality System.
- Bachelor’s Degree in engineering or science-related field.
- Minimum 2 to 5 years’ experience in working in a highly regulated environment.
- Familiarity with ISO13485:2016, ISO 14791, IEC 60601-1:2005 and other relevant standards.
- Strong knowledge of Quality Concepts.
- Strong project management skills and ability to multitask effectively.
- Demonstrated ability to advocate for product excellence and quality.
- Strong analytical skills including practical knowledge of statistical methods.
- Demonstrated ability to work independently.
- Highly developed problem-solving skills.
- Demonstrated ability to effectively work cross-functionally with other departments, including Operations, Product Development, Regulatory Affairs, and Marketing.
- Strong interpersonal, written, oral communication, and negotiation skills.
- Familiarity with cGMP.
- Experience in interacting with regulatory agencies (FDA, Health Canada, etc.) and Auditing Organizations/Testing Laboratories (TUV, Intertek, Nemko, etc.).
- MASc or MS.
- CQE or CRE.
- Familiarity with Six Sigma and/or Lean manufacturing.
- Experience with the medical device product development lifecycle (e.g. risk management, and design/process verification and validation).