What you will be doing :

<ul>
<li>Control documents, data and records of company pertaining to purchase, outsourced activities, Manufacturing &amp; process, sales, quality control, dispatch, post market surveillance and vigilance.</li>
</ul>

<ul>
<li>Demonstrate compliance during an audit (regional/national/international) related to quality and product approvals.</li>
</ul>

<ul>
<li>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.</li>
</ul>

<ul>
<li>Identification, filling, storage and maintenance of documents and QA related records.</li>
</ul>

<ul>
<li>Ensure all the records are filled in timely manner.</li>
</ul>

<ul>
<li>Review batch manufacturing and inspection records and release the batch.</li>
</ul>

<ul>
<li>Responsible for retaining at least one unit of sample from each batch manufactured.</li>
</ul>

<ul>
<li>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.</li>
</ul>

<ul>
<li>Responsible for Design Develop verification and validation protocols along with Design and Development department.</li>
</ul>

<ul>
<li>Training and ensuring all assigned employees are aware of and comply with company policies, quality procedures, and related standard requirement.</li>
</ul>

<ul>
<li>Releasing final product and disposition of Non-conforming material.</li>
</ul>

<ul>
<li>Review product traceability and finished goods release processes.</li>
</ul>

<ul>
<li>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.</li>
</ul>

<ul>
<li>Support projects and new product introductions by establishing key checkpoints for new products and processes.</li>
</ul>

<ul>
<li>Maintain product traceability and finished goods release processes and Authorize for batch release.</li>
</ul>

<ul>
<li>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.</li>
</ul>

<ul>
<li>Responsible to review each department documentation as per defined timeline to check compliance with the standard requirement.</li>
</ul>

<ul>
<li>Responsible for order review.</li>
</ul>

<ul>
<li>Authorize to review any internal process and documentation.</li>
</ul>

<ul>
<li>Authorize to change and implement quality management system according to the standard requirements.</li>
</ul>

<ul>
<li>Authorize to take necessary actions to eliminate Non-conformance of product at any stage.</li>
</ul>

Essential Requirements :

<ul>
<li>2-5 yrs experience, B.E Mechanical/Diploma in Mechanical/B.Pharm/M.Pharm.</li>
</ul>

<ul>
<li>Must have Technical knowledge of Medical Device and ISO 13485.</li>
</ul>

Desirable Requirements :

<ul>
<li>Good Communication.</li>
</ul>

<ul>
<li>Knowledge about CAPA, Batch Release, QMS, SOP, Compliance, Document Control and Audit.</li>
</ul>

Why Work For US :

<ul>
<li>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.</li>
</ul>

<ul>
<li>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.</li>
</ul>

<ul>
<li>We foster a collaborative work environment that encourages creativity, critical thinking, and teamwork, empowering employees to make meaningful contributions and drive positive change.</li>
</ul>

<ul>
<li>At Miraclus Orthotech, we invest in the professional growth and development of our employees, providing ample opportunities for skill enhancement, training, and career advancement.</li>
</ul>

<ul>
<li>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.</li>
</ul>

<ul>
<li>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.</li>
</ul>

<ul>
<li>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.</li>
</ul>

<ul>
<li>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.</li>
</ul>

<ul>
<li>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.</li>
</ul>

<ul>
<li>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. </li>
</ul>

Quality Assurance Executive

India

What you will be doing : Control documents, data and records of company pertaining to purchase, outsourced activities, Manufacturing &amp; 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. 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.

Quality Assurance Executive · Vavdi

Job highlights

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Job Description

Job Description for Quality Assurance Executive

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