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 in Vavdi (UID-16290)

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