Quality Assurance Specialist

🔥 14 hours ago

🇪🇸 Spain – Remote

💵 €55k - €59k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 0%

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Logo of BD

BD

10,000+ employees

Founded 1897

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

💰 $24M Grant on 2020-07

Healthcare • Manufacturing • Healthcare Insurance

BD (Becton, Dickinson and Company) is a global medical technology company dedicated to advancing the world of health. It focuses on developing innovative technologies, services, and solutions to improve safety and efficiency in healthcare. BD offers a wide range of products including medication management solutions, surgical solutions, cervical cancer screening, drug delivery systems, and laboratory services. The company is also involved in infection risk management and provides advanced clinical insights to enhance patient outcomes. With a commitment to global health sustainability and social investing, BD is a leader in healthcare technology and services worldwide.

📋 Description

• Coordinate and execute the regional Quality Compliance program across EMEA • Develop and maintain the annual EMEA internal audit program based on risk, regulatory requirements, and business priorities • Plan, conduct, document, and report internal audits across EMEA locations and functions • Monitor audit findings and support site management with timely implementation and closure of CAPAs • Coordinate and support notified body, certification body, customer, and regulatory audits and inspections • Prepare and consolidate Management Review inputs and reports • Analyze quality metrics and trends to support Management Review discussions and decision-making • Support maintenance and continuous improvement of the Quality Management System • Provide guidance on quality compliance requirements, audit readiness, and best practices • Support CAPA management, quality risk management, document control, change management, training compliance, and quality reporting • Collaborate with regional and global Quality teams to align compliance initiatives and quality objectives • Promote a culture of quality, compliance, and continuous improvement

🎯 Requirements

• Bachelor's degree in Life Sciences, Engineering, Quality Management, or a related discipline • Minimum 3–5 years of experience in Quality Assurance, Quality Compliance, or Quality Systems within a regulated industry • Experience in Medical Devices, Pharmaceutical, Biotechnology, or similar regulated industries • Experience planning and conducting internal audits • Experience supporting external audits and regulatory inspections • Experience preparing management review materials and analyzing quality metrics • Strong knowledge of Quality Management Systems and applicable regulations and standards, including ISO 13485, FDA QSR, and MDR or equivalent • Certified Internal Auditor qualification preferred • Fluent in English; additional European languages are an advantage • Ability to travel within the EMEA region as required

🏖️ Benefits

• Comprehensive Total Rewards program • Reward and recognition opportunities • Competitive compensation and benefits programs • Learning, growth, and development opportunities • Face-to-face collaboration culture supporting learning, progress, and success

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