Quality Assurance Executive · Vavdi

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.

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.