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691 Siemens Jobs

Quality Manager- Accessory Solutions (AS)

8-13 years

Bangalore / Bengaluru

1 vacancy

Quality Manager- Accessory Solutions (AS)

Siemens

posted 22d ago

Job Description

1. Regulatory Knowledge:
  • Understanding of EU MDR 2017/745: In-depth knowledge of the MDR and its application to medical devices and accessories, including Annexes and specific requirements related to accessories.
  • Accessory Classification: Familiarity with how accessories are classified under the MDR (whether they are classified as a medical device or fall under other regulatory frameworks).
  • Knowledge of Harmonized Standards: Knowledge of relevant European harmonized standards and guidelines that apply to medical devices and accessories (e.g., ISO 13485, ISO 14971).
2. Quality Management System (QMS) Expertise:
  • ISO 13485 Compliance: Strong understanding of ISO 13485 requirements and its application to both medical devices and accessories, ensuring quality management systems are in place.
  • Document Control Change Management: Experience managing the documentation process, ensuring proper records, specifications, and design files for both the medical device and its accessories.
  • Risk Management: Knowledge of ISO 14971 for risk management, specifically in the context of accessories and their role in the overall safety of the medical device.
3. Product Lifecycle Management:
  • Design and Development: Ability to oversee the quality aspects of product design and development for accessories, ensuring compliance with regulatory requirements from concept to delivery.
  • Post-Market Surveillance Vigilance: Experience in setting up post-market surveillance systems for accessories, including reporting adverse events and ensuring continued compliance after the product is on the market.
  • Clinical Evaluation: Understanding of clinical evaluation requirements for both medical devices and accessories, ensuring safety and performance criteria are met.
4. Supplier and Vendor Management:
  • Supplier Qualification and Audits: Skills in qualifying suppliers for the accessories, ensuring they meet the necessary regulatory and quality standards.
  • Supplier Quality Assurance: Managing quality expectations for external suppliers, especially if accessories are sourced from third-party vendors.
5. Cross-functional Collaboration:
  • Collaboration with RD and Design Teams: Ability to work closely with design and engineering teams to ensure quality is incorporated into the accessorys design from the start.
  • Regulatory Affairs Coordination: Work with the regulatory affairs team to ensure accessories are compliant with applicable regulations before market release.
  • Customer and Stakeholder Communication: Effective communication with internal stakeholders and customers about the accessory s quality and regulatory status.
6. Training and Leadership:
  • Team Leadership and Training: Ability to lead and train teams on the quality standards required for accessories, promoting a culture of quality.
  • Internal Audits and Compliance Checks: Expertise in conducting internal audits to assess compliance with MDR and ISO standards for accessories, identifying areas for improvement.
7. Problem-Solving and Continuous Improvement:
  • Root Cause Analysis: Expertise in identifying and analyzing quality issues related to accessories, utilizing tools such as CAPA (Corrective and Preventive Actions) and root cause analysis.
  • Continuous Improvement: Driving a culture of continuous improvement, including the application of Lean, Six Sigma, or similar methodologies to optimize processes related to accessories.
8. Knowledge of EU Market Authorization:
  • CE Marking for Accessories: Familiarity with the requirements and process for obtaining CE marking for accessories, including the necessary technical documentation, risk assessment, and clinical evaluations.
  • Conformity Assessment Procedures: Knowledge of the conformity assessment process under the MDR for both the medical device and its accessories, including involvement of Notified Bodies if applicable.
  • bodies, especially for post-market surveillance, vigilance, and compliance audits.
9. Language and Communication Skills:
  • Multilingual Communication: If dealing with international suppliers or regulatory bodies, proficiency in relevant languages (e.g., English, German) would be beneficial for effective communication and documentation.
  • Technical Writing Skills: Ability to create clear and concise technical documentation, including quality plans, reports, and regulatory submissions for accessories.
11. Software and Tools:
  • QMS Software: Proficiency in using quality management software systems to track documentation, CAPAs, audits, and regulatory compliance.
  • Risk Management Tools: Familiarity with risk management software tools to assess, mitigate, and document risks associated with accessories

Employment Type: Full Time, Permanent

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Quality Manager salary at Siemens

reported by 42 employees with 6-18 years exp.
₹8.8 L/yr - ₹32 L/yr
46% more than the average Quality Manager Salary in India
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What Siemens employees are saying about work life

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Flexible timing
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No travel
Day Shift
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