Ingénieur qualité vérifiant la conformité des produits chez Amphenol SOCAPEX. Contribuer à la qualification et à la maintenance des normes de qualité en collaboration avec les équipes internes.
About the role
- Risk Management Expert leading risk management strategies for medical device products at Medtronic. Ensuring regulatory compliance and product safety through effective risk mitigation.
Responsibilities
- Lead risk management strategy for our medical device products
- Create and manage risk management plans and reports, as well as conduct regular risk reviews
- Perform thorough hazard analyses to identify potential risks and implement effective mitigation measures
- Lead Failure Modes and Effects Analyses (FMEAs) in collaboration with project teams
- Analyze and review product complaints to anticipate and prevent future issues
- Conduct detailed risk analyses in conjunction with the system engineering team
- Implement and maintain robust product security measures
- Develop and manage post-market surveillance plans to monitor product performance and safety
- Maintain and curate risk logs
Requirements
- Bachelor’s degree in Engineering, or a related technical field
- In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards
- Strong analytical and problem-solving skills with the ability to conduct thorough root cause analysis
- Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present complex information to stakeholders
- Proven leadership and project management skills with the ability to lead teams and manage multiple projects simultaneously
- Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification is preferred
- Experience in Quality Assurance, Engineering, Capital equipment Industry Experience: Medical device industry
- Proficient in quality assurance practices, risk management, and regulatory compliance.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Senior Softwaretester in Testautomatisierung for DATAGROUP in Krakow or Hybrid. Responsible for designing and maintaining automated tests for web frontends and APIs.
Senior Testing Engineer responsible for testing and commissioning signalling systems for complex projects at AtkinsRéalis. Engaging in project management and continuous improvement processes in a collaborative environment.
Team Leader Quality Assurance at J.R. Simplot ensuring quality products and compliance with specifications. Leading a team to meet operational goals and maintaining standards of safety and sanitation.
Analista de Testes garantindo a qualidade e eficiência em projetos de TI na seguradora. Colabora com times para validar entregas e aplicar testes automatizados nas soluções de software.
Cytiva is looking for a Supplier Quality Engineer to manage supplier change requests and improve quality. Responsibilities include collaboration with suppliers across multiple manufacturing sites globally.
Hybrid Tester role at Demo Company in Paris focusing on software testing and collaboration with development teams.
QA Engineer responsible for manual and automated testing in cybersecurity. Collaborating with development to enhance product quality through testing processes and methodologies.
Senior Expert QA & SHE Officer focusing on quality management in global operations for animal nutrition. Handling incidents, audits, and service quality improvements.
Quality Assurance Engineer at QUALCO ensuring high - quality solutions for clients in the fintech sector. Responsible for manual and API testing, collaborating with development teams, and managing test procedures.