Sr Quality Engineer
Medtronic · Hyderabad · onsite · Posted 30d ago
Undisclosed8–12 yrsfulltimeSourced from
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About this role
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 Prepare and compile product post market data and findings into comprehensive Periodic Safety Update Reports (PSURs) in compliance with regulatory requirements. 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:
- Familiar with ISO 9001, ISO 13485, ISO 14971, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards.
- Good verbal and written communication skills including plan / report development.
- Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Regulation.
- Collaborate with cross-functional teams to gather and analyze data related to the performance and safety of medical devices and independently develop Periodic safety update plan and reports.
- 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.
- Familiar with Literature review, PMCF, IMDRF coding, CAPA and NCMR.
- Hands on experience in signal evaluation trending and reports, preliminary code reviews for the product complaints on periodic basis.
- 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.
- Deliver presentations to the QA organization on status and issues of assigned projects.
- Deliver trainings to departments outside of QA.
- 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.
- Previous experience working in a cross-functional team environment.
- Hands-on experience on Risk Management, Design Controls for Medical Devices.
- Participate when appropriate in audits.
- Experience in collaborating with regulatory affairs teams for submission of safety reports.
Required knowledge and experience:
- B E or B. Tech in Mechanical/Biomedical Engineering
- Minimum 5-8 years of quality engineering experience or equivalence and overall 8-12 years of experience
Nice to Have: - ASQ CQE, CQA, CSQE and/or CRE certification.
- ISO 13485 Internal Auditor / Lead Auditor Certification
- Lean Six Sigma Green Belt or Black Belt
Physical Job Requirements
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 AskHR@medtronic. com .
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.
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.
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
AuditingCfrISO 13485market dataBiomedical EngineeringBiomedicalISO 9001auditsCAPABlack BeltGreen BeltLiterature ReviewPhishinghealthcare technologyHealthcareMedical DevicesCommunication SkillsLiteraturecompliance
About Medtronic
Medtronic
Medical Equipment
850
employees
1979
47 years old
Mumbai, Maharashtra
India
About
A global healthcare technology leader — boldly attacking the most challenging health problems facing humanity with innovations that transform lives.
Industries
Medical Equipment
Employee ratings
679 reviews
3.9/ 5
Culture
3.8
Career growth
3.2
Work-life
3.8
Employees rate it well for
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