Quality Engineer II

IN2 COV - COV Engineering Services PL; Hyderabad; On-site; INR 1,200,000 - 2,100,000; Full time

Job summary

Medtronic is seeking a Quality Engineer to prepare PSURs and lead post-market surveillance activities for medical devices. You will mentor junior engineers and work with regulatory affairs to ensure timely and compliant submissions.

Your role involves analyzing safety data, drafting reports, and implementing quality practices aligned with ISO 13485 and EU MDR. You will collaborate with engineering, manufacturing and regulatory teams to maintain high quality across products, stay ahead of

Qualifications

• BE/BTech in Mechanical or Biomedical Engineering.
• 4–8 years of quality engineering experience preferred.
• Experience with EU MDR, ISO 13485, ISO 14971 and related regulations.

Responsibilities

• Prepare and compile PSURs and regulatory submissions.
• Mentor junior engineers in quality engineering practices.
• Collaborate with cross-functional teams on data related to performance and safety of medical devices.
• Draft PSUR or CER documents.
• Support regulatory affairs and timely submissions to authorities.
• Monitor evolving safety regulations to ensure compliance.
• Develop templates and trainings based on QSRs, standards and guidance.
• Review all deliverables for compliance with development processes.

Skills

Literature review

PMCF

IMDRF coding

CAPA

NCMR

EU MDR

Risk management

Design controls

Verbal and written communication

Quality system awareness

Lean Six Sigma

Education

BE/BTech in Mechanical/Biomedical Engineering

Job description

Careers 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

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.

• 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.

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.
• This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

We 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. 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.

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 These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career‑building resources you need.

Life‑transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting‑edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here.