Bangalore / Bengaluru
4 years ago
48 Applied
JOB ID:33155
Job details
Job Type
Full Time
Functional Area
Other
Industry
Medical/Healthcare/Hospital
Education
Not Specified
Experience Required
6 - 12 Yrs
Key Skills Required
CQE
Other Skills Required
Languages
English
Job Description
About BaxterBaxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.Job SummaryUnder direction of supervisor, responsible for supporting and sustaining Renal Quality Engineering activities related to medical device hardware.Essential Duties and Responsibilities
- Demonstrate quality assertiveness and be able to represent the Quality function in various roles such as product support and lifecycle management.
- Assist in de
About BaxterBaxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.Job SummaryUnder direction of supervisor, responsible for supporting and sustaining Renal Quality Engineering activities related to medical device hardware.Essential Duties and Responsibilities
- Demonstrate quality assertiveness and be able to represent the Quality function in various roles such as product support and lifecycle management.
- Assist in decision making for process improvement efforts
- Provide quality role in assisting with generating Design Plans, reviewing design inputs, outputs, verification, validation and design transfer strategies.
- Support Risk Management activities for sustaining engineering projects.
- Support post market activities such as complaint investigation, complaint trending, CAPA, and FA processes
- Support global Renal manufacturing facilities and associated manufacturing and supplier changes
- Preside as key quality participant in compliance audits and FDA/ministry of health (MOH) inquiries
- BS engineering and7-12 years in related Quality or Engineering field in the medical products industry.
- ASQ (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification highly preferred Strong interpersonal/communication/influencing/negotiation skills.
- Strong analytical and problem solving skills.
- Working knowledge of FDA Regulations
- Demonstrated ability to lead others within small project or investigational environments
- Good technical overview of medical device verification and validation
- Good understanding of FDA QSR Part 820, ISO 13485, EU MDD / EU MDR
- Broad working knowledge of Medical Device Software Development Lifecycle and IEC 62304
- Basic understanding of medical device manufacturing process
- Good Understanding of requirements for Calibration and Qualification of Test & Measurement equipment in labs used for Verification and Validation.
About Company
This is where you can make an impact.
As an innovative, global healthcare leader, Baxter offers advanced products, technologies and therapies that support people to lead healthier, longer lives.
When you join Baxter, you’ll find purpose and pride as we meet the challenges faced by the patients, clinicians, and customers we serve in this rapidly evolving healthcare landscape.
Together, we create a place where we are resilient, focused on our future, and connected by our mission to save and sustain lives.
This is where you can do your best work, where your purpose accelerates our mission.
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