Quality Engineer II

Covidien; Hyderabad; On-site; INR 1,400,000 - 2,200,000; Full time

Benefits offered by this job

Flexible benefits

Job summary

Medtronic Hyderabad is hiring a Supplier Quality Engineer to partner with suppliers and cross-functional teams to ensure quality parts, PPAP deliverables, and regulatory compliance including FDA QSR and ISO 13485. You will lead corrective and preventive actions, audits, and supplier performance monitoring to drive continuous improvement.

The role requires a Bachelor's in Engineering, 5–8 years of quality systems experience, and certifications such as CQE/CQA; Lean Six Sigma Yellow/Green belt is

Qualifications

• Bachelor's degree in Engineering or technical discipline.
• 5–8 years of quality systems experience.
• Experience in supplier management.
• Knowledge of FDA QSR & ISO 13485.
• CQE/CQA certifications are a plus.
• Lean Six Sigma Yellow/Green Belt preferred.

Responsibilities

• Ensure suppliers deliver quality parts, materials, and services.
• Lead supplier corrective and preventive actions (SCAR) and projects.
• Manage SCR lifecycle and PPAP deliverables for new/legacy products.
• Support NPD quality engagement with cross-functional teams.
• Conduct supplier audits and drive continuous improvement.

Skills

Quality systems

Supplier management

Regulatory knowledge

CQE

CQA

Lean Six Sigma

Communication

Cross-functional

Education

Bachelor's degree in Engineering

Tools

FDA QSR/ISO 13485

Job description

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

A typical day involves partnering with suppliers and cross-functional teams to ensure delivery of high-quality, compliant components through PPAP approvals, SCR lifecycle management, and supplier performance monitoring. You drive corrective and preventive actions, support NPD quality engagement, execute audits, and ensure adherence to regulatory and industry standards while enabling continuous supplier improvement.

Responsibilities may include the following and other duties may be assigned:

• Ensure that suppliers deliver quality parts, materials, and services.
• Support and manage Supplier Corrective and Preventive Action plans and projects to improve quality performance of a supplier.
• Handle complete SCR( Supplier change request ) life cycle .
• Deliver & complete PPAP deliverables for new product & legacy product changes using process validation approach .
• Evaluate supplier performance on periodic basis & take necessary action for continous improvement.
• Provide Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.
• Colloborate with cross function team for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and ensure product quality and continuous improvement.
• Ensure purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
• Collaborate with component engineers to develop and deliver the product acceptance sampling strategy, approved supplier list coordination, supplier owned quality deployment, PFMEA,MSA, ,Control Plans and relevant quality tools and methodologies for new products and legacy product.
• Prepare receiving inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.
• Support in supplier audit execution and ASL management.
• Any other tasks as assigned.

Required knowledge and experience:

• Bachelors degree in Engineering, Science, or Technical Discipline required and 5-8 years of quality systems experience. Experience in supplier management is added advantage .

• Good communication skills, both oral and written.

• Comfortable working with international and multi-cultural department and groups in different time zones.

• Timely & accurate delivery quality work.

• Ability to work well under pressure and maintain positive, enthusiastic attitude.

• Ability to work in a fast-paced environment.

• Nice to Have:

• Good interpersonal skill.

• Previous experience working with global team (Aerospace, Defence, Med device, automobile preferably).

• Exposure to FDA Quality System Regulation & ISO 13485 standard .

• Quality certification – CQE,CQA.

• Working knowledge of Standard, Guidance, and Regulations.

• Lean Six Sigma Yellow belt /Green Belt.

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. 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).

About Medtronic

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.

Learn more about our business, mission, and our commitment to diversity here