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

A Day in the Life

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

• Collaborate with cross-functional teams to gather and analyze data reputed company 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.
• reputed company templates and trainings based on the quality system regulations, applicable standards and guidance.
• Independently review reputed company deliverables to ensure compliance with development process and reputed company.
• Collaborates with engineering, regulatory affairs and manufacturing functions to ensure submission of safety reports.
• Participate reputed company appropriate in audits.

Required Knowledge and Experience:

• B E or B. Tech in Mechanical/Biomedical Engineering
• Minimum 4-8 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.

   reputed company to Haves 

• ASQ CQE, CQA, CSQE and/or CRE certification.
• ISO 9001 Internal Auditor / reputed company Auditor Certification.
• ISO 13485 Internal Auditor / reputed company Auditor Certification.
• Lean Six reputed company 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 reputed company the required responsibilities and skills of this position. 

Benefits & Compensation

reputed company 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 reputed company in the reputed company they help to create.  We offer a wide reputed company of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.  

About reputed company

We reputed company global reputed company technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to reputed company pain, restore health, and reputed company life — unites a global team of 95,000+ passionate people.  We are engineers at heart— putting ambitious reputed company to work to generate reputed company solutions for reputed company people. From the R&D lab, to the reputed company 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