Urgent Requirement of Quality Assurance Executive / QA Executive for Kheda, Gujarat location.

Quality Assurance Executive
What You Will Be Doing

Control documents, data and records of company pertaining to purchase, outsourced activities, Manufacturing & process, sales, quality control, dispatch, post market surveillance and vigilance.
Demonstrate compliance during an audit (regional/national/international) related to quality and product approvals.
Establish, maintain and update master lists such as master list of documents, records, Obsolete list, Revision history and distribution retrieval list, machines list, Instrument and equipments list etc.
Identification, filling, storage and maintenance of documents and QA related records.
Ensure all the records are filled in timely manner.
Review batch manufacturing and inspection records and release the batch.
Responsible for retaining at least one unit of sample from each batch manufactured.
Identify and implement CAPA for non-conformance observed during any stage of lifecycle of medical device, in internal/external audits or as a product complaint.
Responsible for Design Develop verification and validation protocols along with Design and Development department.
Training and ensuring all assigned employees are aware of and comply with company policies, quality procedures, and related standard requirement.
Releasing final product and disposition of Non-conforming material.
Review product traceability and finished goods release processes.
Establishing and maintaining programs, procedures and controls ensuring that product and raw materials are manufactured and controlled as per established procedures, specifications, Medical Device regulations and ISO standards.
Support projects and new product introductions by establishing key checkpoints for new products and processes.
Maintain product traceability and finished goods release processes and Authorize for batch release.
In-charge of maintaining all the records, site master file, technical construction files, design history file, device master file, design history records in accordance with related standard.
Responsible to review each department documentation as per defined timeline to check compliance with the standard requirement.
Responsible for order review.
Authorize to review any internal process and documentation.
Authorize to change and implement quality management system according to the standard requirements.
Authorize to take necessary actions to eliminate Non-conformance of product at any stage.

Interested candidate kindly shares their resume on 7984420926/9313809613 or on [HIDDEN TEXT]
Essential Requirements

2-5 yrs experience, B.E Mechanical/Diploma in Mechanical/B.Pharm/M.Pharm.
Must have Technical knowledge of Medical Device and ISO 13485.

Desirable Requirements

Good Communication.
Knowledge about CAPA, Batch Release, QMS, SOP, Compliance, Document Control and Audit.

Why Work For US

Miraclus Orthotech Pvt Ltd is an innovative and dynamic company at the forefront of Orthopaedic technology, providing employees with a unique opportunity to contribute to the advancement of medical science.
Joining Miraclus Orthotech means becoming part of a team dedicated to improving the lives of patients by developing cutting-edge Orthopaedic solutions that enhance mobility, reduce pain, and restore quality of life.
We foster a collaborative work environment that encourages creativity, critical thinking, and teamwork, empowering employees to make meaningful contributions and drive positive change.
At Miraclus Orthotech, we invest in the professional growth and development of our employees, providing ample opportunities for skill enhancement, training, and career advancement.
As a leader in the Orthopaedic industry, we offer a diverse range of projects and challenges, ensuring that every day brings new opportunities to learn, innovate, and excel.
We prioritize work-life balance and employee well-being, offering flexible work arrangements, comprehensive benefits packages, and a supportive culture that values mental and physical health.
Miraclus Orthotech values diversity and inclusivity, fostering an environment that celebrates different perspectives, experiences, and backgrounds, making it an enriching and fulfilling place to work.
We are committed to maintaining the highest standards of ethics, integrity, and patient safety, providing our employees with a strong sense of purpose and pride in the work they do.
Joining Miraclus Orthotech means being part of a global network of professionals, collaborating with experts and thought leaders in the field of Orthopaedics to drive innovation and make a lasting impact.
Our company culture promotes open communication, transparency, and a shared passion for making a difference, creating a supportive and engaging work environment that inspires employees to thrive.

What You'll Achieve

By joining Miraclus Orthotech, you will have the opportunity to make a tangible impact on the lives of patients worldwide, contributing to the development of innovative Orthopaedic solutions that improve mobility and enhance quality of life.
As a member of our team, you will play a vital role in advancing Orthopaedic technology, working alongside industry experts and thought leaders to drive innovation and shape the future of Orthopaedic care.
At Miraclus Orthotech, you will have the chance to expand your knowledge and expertise in the field of Orthopaedics, with access to cutting-edge technologies, training programs, and continuous learning opportunities.
You will work in a collaborative and dynamic environment, where your ideas and contributions will be valued and encouraged, allowing you to unlock your full potential and achieve professional growth.
As part of our team, you will be involved in multidisciplinary projects and collaborations, collaborating with talented professionals from diverse backgrounds, and fostering a culture of innovation and collaboration.
Working at Miraclus Orthotech, you will have the chance to develop and refine your skills through challenging and meaningful projects, contributing to the development of groundbreaking Orthopaedic solutions that push the boundaries of medical science.
You will have the opportunity to work with state-of-the-art facilities and advanced tools, enabling you to carry out your work with precision and efficiency, ensuring the highest quality standards in our products and services.
At Miraclus Orthotech, we encourage and support professional growth and career advancement, providing mentorship, leadership opportunities, and a clear path for personal and professional development within the organization.
As a valued member of our team, you will have the satisfaction of working in a mission-driven company that prioritizes patient well-being, ethical practices, and the highest standards of quality in all aspects of our work.
By working at Miraclus Orthotech, you will be part of a global network of professionals, collaborating with experts from around the world and expanding your professional network, opening doors to future opportunities and career growth.

Who We Are

Miraclus Orthotech Pvt Ltd is a leading Orthopaedic technology company dedicated to transforming the field of Orthopaedics through innovative solutions and advanced medical devices.
We are a team of passionate professionals, including engineers, researchers, and medical experts, united by a common goal of improving patient outcomes and revolutionizing Orthopaedic care.
With a strong focus on research and development, we leverage cutting-edge technologies and scientific advancements to create state-of-the-art Orthopaedic implants and surgical instruments.
Miraclus Orthotech takes pride in its commitment to excellence, upholding the highest quality standards in our products, and prioritizing patient safety and satisfaction.
As an organization, we strive to make a positive impact in the global healthcare community by delivering reliable, innovative, and patient-centric Orthopaedic solutions that address the unique needs of individuals around the world.

Salary Range : Between 2 LPA to 6 LPA

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