Premium Employer

i

This company page is being actively managed by Siemens Team. If you also belong to the team, you can get access from here

Siemens Verified Tick

Compare button icon Compare button icon Compare
filter salaries All Filters

708 Siemens Jobs

Quality Manager- Accessory Solutions (AS)

8-13 years

Bangalore / Bengaluru

1 vacancy

Quality Manager- Accessory Solutions (AS)

Siemens

posted 19d 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

Read full job description

Prepare for Quality Manager roles with real interview advice

Top Siemens Quality Manager Interview Questions

Q1. Count Inversions Problem Statement Given an integer array ARR of size N , your task is to find the total number of inversions that exist in ... read more
Q2. Maximum Subarray Sum Problem Statement Given an array arr of length N consisting of integers, find the sum of the subarray (including empty ... read more
Q3. Remove Character from String Problem Statement Given a string str and a character 'X', develop a function to eliminate all instances of 'X' ... read more
View all 367 questions

What people at Siemens are saying

4.9
 Rating based on 5 Quality Manager reviews

Likes

Work Life balance

  • Salary - Excellent
  • +6 more
Dislikes

Nothing , all good

Read 5 Quality Manager reviews

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
View more details

What Siemens employees are saying about work life

based on 4.8k employees
75%
69%
47%
94%
Flexible timing
Monday to Friday
No travel
Day Shift
View more insights

Siemens Benefits

Submitted by Company
Flexible Work Options and Hybrid Work Models
Employee Engagement
Health & Wellness
Career Development
Submitted by Employees
Health Insurance
Job Training
Soft Skill Training
Cafeteria
Work From Home
Free Transport +6 more
View more benefits

Compare Siemens with

Schneider Electric

4.1
Compare

Siemens Energy

4.1
Compare

ABB

4.1
Compare

BHEL

4.1
Compare

Larsen & Toubro Limited

4.0
Compare

TCS

3.7
Compare

Infosys

3.6
Compare

Wipro

3.7
Compare

HCLTech

3.5
Compare

Tech Mahindra

3.5
Compare

Bosch

4.2
Compare

Mahindra & Mahindra

4.1
Compare

Johnson Controls

3.6
Compare

Honeywell Automation

3.8
Compare

Rockwell Automation

3.7
Compare

Wipro PARI

3.4
Compare

Addverb Technologies

3.6
Compare

Titan Engineering & Automation

4.0
Compare

Falcon Autotech

3.9
Compare

Technosoft Engineering Projects Limited

3.9
Compare

Similar Jobs for you

Quality Manager at Siemens Healthcare

Bangalore / Bengaluru

8-15 Yrs

₹ 18-19 LPA

Product Risk Manager at Siemens Limited

Bangalore / Bengaluru

15-17 Yrs

₹ 17-21 LPA

Quality Manager at Philips India Limited

Pune

12-17 Yrs

₹ 20-25 LPA

Quality Manager at Siemens Limited

Bangalore / Bengaluru

12-16 Yrs

₹ 14-19 LPA

Auditor at Novartis Healthcare Pvt. Ltd.

Mumbai

15-16 Yrs

₹ 17-18 LPA

Design & Quality Engineer at Philips India Limited

Pune

8-12 Yrs

₹ 16-18 LPA

Test Designer at Philips India Limited

Pune

3-7 Yrs

₹ 12-16 LPA

Quality Manager at Kairish Shared Services

Daman & Diu

10-14 Yrs

₹ 12-16 LPA

Product Developer at Siemens Limited

Gurgaon / Gurugram

10-15 Yrs

₹ 20-27.5 LPA

System Engineer at Philips India Limited

Bangalore / Bengaluru

11-15 Yrs

₹ 22.5-30 LPA

Quality Manager- Accessory Solutions (AS)

8-13 Yrs

Bangalore / Bengaluru

19d ago·via naukri.com

Python Developer

3-6 Yrs

Bangalore / Bengaluru

2d ago·via naukri.com

Software Developer (C#; Angular) - PL 10

6-11 Yrs

Bangalore / Bengaluru

2d ago·via naukri.com

Software Developer (C#, WPF)

3-5 Yrs

Pune

2d ago·via naukri.com

Test Center Developer - Railway Infrastructure

3-5 Yrs

Pune

2d ago·via naukri.com

Sr. Java Full Stack Developer

5-8 Yrs

Pune

2d ago·via naukri.com

Senior Software Developer (JAVA)

6-9 Yrs

Bangalore / Bengaluru

2d ago·via naukri.com

Software Developer (JAVA)

4-8 Yrs

Bangalore / Bengaluru

2d ago·via naukri.com

Principal Software Engineer

8-13 Yrs

Noida

2d ago·via naukri.com

Power Systems Design and Control Developer

5-10 Yrs

Bangalore / Bengaluru

2d ago·via naukri.com
write
Share an Interview