Ingénieur Qualité II

Medtronic plc; Hyderabad; On-site; INR 700,000 - 1,100,000; Full time

Benefits offered by this job

Medtronic Incentive Plan (MIP)

Flexible Benefits Package

Job summary

Medtronic plc in Hyderabad is seeking a Quality Engineer II to prepare PSURs, mentor junior engineers, and ensure compliance with ISO 13485 and EU MDR across cross-functional teams. You will draft PSURs/CERs, work with regulatory affairs, and support audits while applying quality engineering best practices.

The role requires 4–8 years in quality engineering, strong documentation skills, and hands-on experience with medical device standards; a CQE/CQA/CSQE/CRE certification is a plus.

Qualifications

• Bachelor's degree in Mechanical or Biomedical Engineering
• 4–8 years of quality engineering experience
• Experience with EU MDR, ISO 13485, ISO 14971, 21 CFR part 820/11
• Post-market surveillance and PSUR knowledge
• CQE/CQA/CSQE/CRE certification is a plus

Responsibilities

• Prepare PSURs and CER documents
• Mentor junior engineers in quality practices
• Collaborate with regulatory affairs, manufacturing, and medical experts
• Lead audits and CAPA/NCMR processes and ensure compliance

Skills

CQE/CQA/CSQE/CRE

Regulatory knowledge

Quality systems

Cross-functional collaboration

Education

B.E. or B.Tech in Mechanical/Biomedical Engineering

Job description

## Quality Engineer IIApply: Flexible Work Arrangement: Nanakramguda, Hyderabad, India: Full time: Posted Today: R74141Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.# **A Day in the Life**As Quality Engineer you will prepare and compile product post market data and findings into comprehensive Periodic Safety Update Reports (PSURs) in compliance with regulatory requirements. You will be serving as a mentor to junior engineers, providing guidance and support in quality engineering practices within the realm of medical devices.**Responsibilities may include the following and other duties may be assigned: *** Collaborate with cross-functional teams to gather and analyze data related to the performance and safety of medical devices.* Drafting and authoring PSUR or CER documents.* Partner with regulatory affairs and medical experts to ensure accurate and timely submission of PSURs to regulatory authorities.* Continuously monitor and stay updated with evolving safety regulations and guidelines to ensure PSUR compliance.* Develop templates and trainings based on the quality system regulations, applicable standards and guidance.* Independently review all deliverables to ensure compliance with development process and the standard.* Collaborates with engineering, regulatory affairs and manufacturing functions to ensure submission of safety reports.* Participate when appropriate in audits. **Required Knowledge and Experience:*** B E or B. Tech in Mechanical/Biomedical Engineering* Minimum 4 to 8 years of quality engineering experience.* Familiar with Literature review, PMCF,IMDRF coding, CAPA and NCMR.* Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator.* Hands-on experience on EU MDR, Risk Management, Design Controls for Medical Devices.* Familiar with ISO 13485, ISO 14971,21 CFR part 820, 21 CFR part 11 and EU MDR and product specific industry standards.* Understanding of post-market surveillance processes and adverse event reporting.* Knowledge of risk management principles and hazard analysis in the context of medical devices.* Good verbal and written communication skills including plan / report development.* ASQ CQE, CQA, CSQE and/or CRE certification.* ISO 9001 Internal Auditor / Lead Auditor Certification.* ISO 13485 Internal Auditor / Lead Auditor Certification.* Lean Six Sigma Green Belt or Black Belt.* May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. **Physical Job Requirements** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.**Recruitment Fraud Alert** We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [e-mail].# **Benefits & Compensation****Medtronic offers a competitive Salary and flexible Benefits Package** A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).### Who We AreWe lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.### What We Do**We change lives**. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.**We build extraordinary solutions as one team**. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.**This life-changing career is yours to engineer**. By bringing your ambitious ideas, unique perspective and contributions, you will...* **Build** a better future, amplifying your impact on the causes that matter to you and the world* **Grow** a career reflective of your passion and abilities* **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning