Specialist -Medical Devices Validation and Verification
1 month ago
At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have proven end to end expertise in the field of biosimilars, from its development, manufacturing, clinical development, regulatory approvals to commercialization. We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe.
Responsibilities:
- Represent the Design Quality function on device development project teams and cross functional co-ordination with multiple departments including R&D, Quality Control, Manufacturing and Regulatory Affairs.
- Ensure that device development projects and changes to existing devices are conducted in compliance with the FDA 21CFR Part 820 Quality System Regulation, ISO 13485 Regulations, and other applicable standards like ISO 14971.
- Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting devices can be adequately manufactured and verified.
- Lead or support design activities including design verification, validation, test procedure development, usability engineering, and risk management.
- Set-up of Testing Infrastructure, test benches, jigs and fixtures for testing of mechanical and electro-mechanical Drug Delivery System.
- Plan and execute verification of Prototypes, Pilot batch, feasibility runs for Drug Delivery System.
- Generate or apply statistical methods with appropriate risk-based justification.
- Hands-on experience in Design History File compilation / Technical file documentation.
- Support internal and external inspections/ regulatory audits.
- Promote continuous improvement in design control activities and use of quality tools with design team.
- In-depth knowledge and understanding of 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, 21 CFR 4 Regulation of Combination Products, 14971 Risk Management Standard, MDD, MDR, IEC/EN 62366 Application of Usability Engineering to Medical Devices, and ANSI HE75 Human Factors Engineering in Design of Medical Devices
Secondary responsibilities:
- Experience interacting with regulatory agencies and notified bodies
- Experience with process improvements, process qualification and validation.
- Experience in complaint investigation, corrective action and preventive action system, statistical methods, quality risk management and Post Market Surveillance.
- Experience: 6 to 9 Years.
-
Linux System Validation Engineer
2 weeks ago
Palakkad, Kerala, India Tata Consultancy Services Full timeTata Consultancy Services is seeking a highly skilled Linux System Validation Engineer to join our team. In this role, you will be responsible for validating the ROCm Stack on various AMD GPUs.This position requires strong technical skills and excellent problem-solving abilities. You should have good understanding of test and development lifecycle, QA...
-
SoC/IP Verification Lead
3 months ago
Palakkad, India Texas Instruments Full timeWho are we and what do we do?The Custom product business is delivering industry leading custom IC system solutions including display and touch power products, camera PMICs, charger power products, power switches/muxes, Laser drivers, High speed communication interfaces. Our solutions integrate signal chain and power components, that enable TI customers to...
-
Credit Controller
4 weeks ago
palakkad, India ICG Medical Full timeJob Title: Credit ControllerLocation: Noida/GurgaonAbout the company: Greenstaff Canada, a leading healthcare staffing agency in the country, is managed by two senior Registered Nurses with expertise in both acute care and community-based healthcare organizations. Our team, including a dedicated business specialist focused on long-term care and retirement...
-
Medical Care Professional
4 weeks ago
Palakkad, Kerala, India JobStars HR Solutions Pvt Ltd Full timeJob DescriptionWe are seeking a highly skilled Medical Care Professional to join our team at JobStars HR Solutions Pvt Ltd. As a key member of our healthcare facility, you will be responsible for delivering exceptional patient care and collaborating with our medical staff.To succeed in this role, you must possess excellent communication skills, patience, and...
-
Clinical Healthcare Specialist
4 weeks ago
Palakkad, Kerala, India JobStars HR Solutions Pvt Ltd Full timeClinical Healthcare SpecialistWe are seeking an experienced and compassionate Clinical Healthcare Specialist to join our team at JobStars HR Solutions Pvt Ltd.The successful candidate will be responsible for delivering high-quality patient care in a fast-paced environment, working closely with doctors to diagnose and treat patients. Strong communication and...
-
Analog Layout Engineer
1 month ago
Palakkad, India L&T Semiconductor Technologies Full timeAbout Us:L&T Semiconductor Technologies (LTSCT), a fully owned subsidiary of L&T, is the first major Indian Semiconductor product company - a fabless company for designing & delivering Smart Devices for Global Customers. A company that provides Semiconductor Devices and Technology partnerships by helping customers realise energy efficient, high-performance...
-
Mental Health Specialist
4 weeks ago
Palakkad, Kerala, India Shalom Institute of Mental Health and Research Full timeJob Description:Clinical Psychologist position at Shalom Institute of Mental Health and Research providing comprehensive mental health solutions, specialized treatments, and de-addiction services.Key Responsibilities:Conduct psychological testing and assessmentsProvide clinical supervision and guidanceConduct counseling psychology sessionsContribute to...
-
Senior Mechanical Design Engineer
4 weeks ago
Palakkad, India Tonbo Imaging Full timeTonbo Imaging seeks a Sr./Jr. Mechanical Design Engineer with comprehensive experiencein mechanical design, covering the full product lifecycle from initial concept and prototypingto production transfer. This role is ideal for a proactive professional skilled in designing,testing, and refining electro-optical devices and supporting product integrity in...
-
Senior Mechanical Design Engineer
4 weeks ago
palakkad, India Tonbo Imaging Full timeTonbo Imaging seeks a Sr./Jr. Mechanical Design Engineer with comprehensive experiencein mechanical design, covering the full product lifecycle from initial concept and prototypingto production transfer. This role is ideal for a proactive professional skilled in designing,testing, and refining electro-optical devices and supporting product integrity in...
-
Neurosurgeon
1 week ago
Palakkad, India GLOBAL PLACEMENTS Full timeWe are hiring Clinical Associates and Resident Physicians/Consultants/Specialists for Singapore. You will assist in all aspects of medical procedures and patient care in various departments. Suitable candidates will be offered employment on a 2-year contract.Clinical Associates : ✅MBBS + Minimum 3yrs exp Post Internship , PG / Royal College Membership or...
-
Network Data Expert
2 weeks ago
Palakkad, Kerala, India Tata Consultancy Services Full timeJob SummaryTata Consultancy Services is seeking a highly skilled Network Data Expert to join our team in Bangalore or Hyderabad. As a key member of our infrastructure team, you will be responsible for designing, implementing, and managing network security solutions using Firewalls and Load Balancers.About the RoleThe ideal candidate will have hands-on...
-
Senior Microsoft Endpoint Management Specialist
4 weeks ago
Palakkad, India thinkbridge Full timeWe are seeking a highly skilled Senior Microsoft Endpoint Management Specialist to lead and manage our enterprise identity and device management infrastructure. The ideal candidate will have expert-level proficiency in Microsoft Entra ID, Intune, MDM, Conditional Access Policies, MECM, SCCM, and related technologies. This role requires deep technical...
-
Network Security Specialist
1 month ago
Palakkad, Kerala, India Tata Consultancy Services Full timeJob Role - Network Security-WirelessExperience Range: 8 to 12 yearsJob DescriptionRoles and responsibilities:Configure and troubleshoot wireless networks using Cisco and Aruba controllers, access points, and other devices.•Design and implement advanced firewall configurations and policies.•Perform operational activities to maintain firewall systems,...
-
Eeg Technician
8 months ago
Palakkad district, India Mother Care Hospital Full timeEEG technicians are trained to operate machines known as electroencephalographs, which are used to measure and record the electrical activity of brain waves via electrodes secured to the patient's scalp. The technicians use these devices to administer tests called electroencephalograms (EEGs), which may then detect brain disorders or damage. EEG technicians...
-
Healthcare Professional
2 weeks ago
Palakkad, Kerala, India JobStars HR Solutions Pvt Ltd Full timeNurse(Keralities Required)We are looking for a skilled and compassionate nurse to join our team at JobStars HR Solutions Pvt Ltd, where you will have the opportunity to provide high-quality medical care in our state-of-the-art healthcare facility. The successful candidate will be responsible for recording vital signs, assisting doctors with diagnoses, and...
-
IT Executive
6 months ago
Palakkad district, India Palakkad Institute of Medical Sciences Full timeConfigure and install various network devices and services (e.g., routers, switches, firewalls, load balancers, VPN, QoS) - Perform network maintenance and system upgrades including service packs, patches, hot fixes and security configurations - Monitor performance and ensure system availability and reliability - Monitor system resource utilization,...
-
Palakkad, Kerala, India QR678 Full timeOverviewA highly competitive Sales and Marketing Director opportunity has arisen at QR678, a leading company in the Clinical Aesthetics industry. This is a full-time on-site role that requires strong leadership skills, marketing expertise, and business acumen to drive brand growth.About UsQR678 is a pioneering company in trichology, recognized for its...
-
Software Quality Assurance Specialist
1 week ago
Palakkad, Kerala, India Aviz Networks Full timeAbout Aviz NetworksAviz Networks is a dynamic technology company that delivers robust, scalable, and high-performance networking solutions to enterprise data centers. Our team of engineers and innovators has built data platforms for leading cloud providers, cloud mobility platforms, and robust network infrastructures.Job OverviewWe are seeking a...
-
Dream Destination Specialist
4 days ago
Palakkad, Kerala, India Pickyourtrail Full timeJob SummaryWe are seeking a highly motivated and results-driven Travel Consultant to join our team at Pickyourtrail. As a key member of our sales team, you will play a vital role in crafting unforgettable travel experiences for our clients.About UsPickyourtrail is a leading travel company that specializes in creating bespoke itineraries for travelers. Our...
-
Senior SAP Developer
1 month ago
Palakkad, Kerala, India Norsk Hydro Full timeJob Title: Senior SAP DeveloperJob Description:The Senior SAP Developer is a key member of our development team, responsible for delivering high-quality solutions using SAP technology. Key responsibilities include:Developing and enhancing ABAP objects, including reports, function modules, smartforms, and OO programmingDesigning and implementing SAP logic for...