Lead Quality Assurance Engineer
1 week ago
As a Lead Quality Assurance Engineer at InfraredX, you will play a crucial role in ensuring the excellence of our product designs, sourcing, and manufacturing processes. Your expertise will guide the development teams during the transition of intricate electromechanical medical devices from concept to production. You will be responsible for formulating, reviewing, and executing engineering modifications while establishing quality inspection standards.
Key Responsibilities:
- Design and validate testing methodologies and inspection protocols. Collaborate in the creation of testing documentation and reports as necessary.
- Implement and assess engineering change requests.
- Establish product acceptance criteria and analyze process capabilities.
- Engage in product risk assessments and FMEA evaluations.
- Identify, prioritize, communicate, and resolve quality challenges in a fast-paced and evolving business landscape.
- Assist in the oversight and certification of controlled environments.
- Develop and apply effective process controls to facilitate the design, qualification, and production of products.
- Generate and analyze quality metrics to identify trends impacting product quality. Conduct failure analyses and drive corrective actions to address recurring issues through the CAPA process.
- Contribute to the development of inspection criteria for products, work-in-progress, and sourced components.
- Participate in NMR/MRB activities, including material evaluations.
- Engage in internal and external audits and contribute to quality system enhancement activities to ensure compliance with various regulatory standards.
- Support the complaint management process as needed.
- Assist in design control initiatives as required.
Requirements:
- Bachelor's degree in a technical field, preferably in Electrical or Mechanical Engineering.
- 5 to 7 years of experience in the medical device sector.
- Excellent written and verbal communication skills, with a proven track record in utilizing quality tools and methodologies.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Familiarity with 21 CFR 820, MDD/MDR, ISO 13485, ISO 14971, design verification, process validation, product design control, CAPA, FMEA, and Kaizen methodologies.
- Ability to work independently and collaboratively within a cross-functional team, manage multiple tasks, and meet stringent deadlines.
- ISO 19011 certification is a plus.
- Current ASQ certification is advantageous.
- Ability to interact effectively with all organizational levels.
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