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Quality Manager- Accessory Solutions (AS)
8-13 years
Bangalore / Bengaluru
1 vacancy
Quality Manager- Accessory Solutions (AS)
Siemens
posted 4d ago
Job Role Insights
Flexible timing
Key skills for the job
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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What people at Siemens are saying
Rating based on 5 Quality Manager
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Anonymous · Engineering - Software & QA
in Aurangabad
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Work Life balance
- Salary - Excellent
+6 more
Dislikes
Nothing , all good
Quality Manager salary at Siemens
reported by
43
employees
with 6-18
years exp.
₹8.8
L/yr - ₹29
L/yr
44%
more
than the average Quality Manager Salary in India
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What Siemens employees are saying about work life
based on 4.7k employees
Flexible timing
Monday to Friday
No travel
Day Shift
Siemens Benefits
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Flexible Work Options and Hybrid Work Models Employee Engagement Health & Wellness Career Development
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