Quality Engineer II
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What you'll do
- 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.
What they're looking for
- 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.
Nice to have
- 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.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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 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 AskHR@medtronic.com.
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).
Company
Company facts come from this company's own listings. We only show what the postings themselves carry.