Quality Engineer (Hardware & Production), Remote, Portugal Residents only

July 25

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Sword Health

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Sword Health is the world’s fastest growing virtual MSK care provider, on a mission to free two billion people from pain

Digital Health • medical devices • machine learning • Artificial Intelligence • physical therapy

201 - 500

Description

• Develop and implement quality assurance processes and procedures specific to hardware development for medical devices. • Guide product development teams through our QMS and Design and Development process to ensure hardware is developed in compliance with internal procedures as well as FDA and ISO and other regulatory bodies requirements. • Oversee Design Transfer activities into product from a quality perspective • Collaborate with cross-functional teams to establish and maintain quality standards for medical device hardware production. • Develop and implement quality control procedures, inspection controls, and testing methodologies. • Conduct regular audits of production processes to identify and rectify non-compliance issues. • Identify opportunities for process optimization and efficiency enhancement within the production environment. • Overseeing the QC technicians • Propose and implement corrective and preventive actions (CAPAs) to address quality issues and drive continuous improvement. • Stay updated and provide guidance on relevant industry standards, regulations, and guidelines (e.g., ISO13485, FDA QSR, FDA 21 CFR 820.30, IEC 14971) to ensure compliance in all aspects of hardware production. • Evaluate and qualify suppliers, ensuring they meet quality and performance requirements. • Conduct supplier audits and establish quality agreements to maintain high standards of incoming components and materials. • Lead investigations into quality incidents, utilizing tools such as 5 Whys, Fishbone Diagrams, and Failure Modes and Effects Analysis (FMEA). • Implement corrective actions to prevent recurrence of identified issues. • Conduct root cause analysis for Non Conforming Products and implement corrective and preventive actions (CAPAs) as necessary. • Collaborate with cross-functional teams to identify, assess, and mitigate risks associated with hardware development for medical devices. Support the creation of hardware risk analyses and test strategies to ensure safe and reliable products are launched to SWORD’s high quality standards. • Prepare and maintain accurate and comprehensive documentation of quality-related activities, including inspection reports, test results, and compliance documentation. to software quality activities, including reports, test plans, and risk assessments. • Prepare and deliver regular reports on quality metrics and key performance indicators (KPIs) to management. • Work closely with software development and production teams to provide guidance on quality-related matters and facilitate effective communication between teams. • Provide training and support to internal teams on quality-related processes and procedures related to hardware development and production.

Requirements

• Bachelor's degree in Science, Engineering or related discipline. • 2+ years of experience in Quality Engineering (Hardware and/or Production) or a related role within the medical device or pharmaceutical industry. • Experience in medical device new product development. • Familiarity with relevant quality standards and regulations: Quality Management System ISO 13485, FDA 21 CFR 820.30, IEC 14971 Risk Management. • Experience with risk management methodologies (e.g. FMEA) and with statistical analytical tools. • Strong analytical skills and proficiency in root cause analysis techniques • Six Sigma or Lean Manufacturing certification is preferred. • Excellent analytical, problem-solving and communication skills • Fluent in English