Engineer - Quality assurance jobs in Bangalore at Vasmed Health Sciences Pvt. Ltd.

We are seeking a Quality Assurance Engineer to join our quality team in our effort to design, develop and manufacture most advanced medical devices (including MDD Class III including implantable devices).
The Quality Assurance Engineer is responsible for supporting the Quality Manager in maintaining and ensuring that the Vasmed Health Sciences Pvt. Ltd. quality system meets the IEC, ISO 13485, FDA, MDD and DCGI requirements and all local / international market medical device requirement.
Quality Assurance Engineer will support Quality Manager with the day-to-day quality related operations of the business to ensure that it meets its core QMS objectives in an efficient and timely manner.
This is a hands on role that requires the application of project management, quality assurance, regulatory affairs knowledge and engineering skills to a. Maintain design control b. Ensure adequate control of manufacture c. Continue to innovate and seek improvements across business activities.
At Vasmed, each employee can make a difference and has the power, either individually or as a team, to influence the success of the company.
We are team-oriented, fast-paced and progressive.
We value people with ideas who partner with others both internally and externally to take action and accomplish goals.

Main Responsibilities:

Develop, administer and maintain all quality assurance procedures and activities required to ensure that companies processes and products are in compliance with applicable quality standards and requirements (including ISO 13485, GMP, FDA QSRs, DCGI).
Manage and establish/maintain compliance with EU market MDD 93/42/EEC directive (including CE mark application or self-declarations via technical files)
Define quality control standards and tests; specify test equipment and procedures.
Responsible for IEC certifications for new products in association with Engineering and R&D team.
Create regulatory plan for R&D products.
Responsible for supporting and working with R&D and manufacturing to develop validation protocols for production processes, and generating the final report covering the validation results and a recommendation for approval or disapproval for the release of the process to manufacturing
Management of key activities and suppliers for product development and manufacturing pathways
Facilitation and reporting of product release testing
Development of experimental techniques and apparatus to evaluate product performance on an ongoing basis (to include investigations of customer complaints/manufacturing issues)
Responsible for ongoing management of: Maintenance and calibration of equipment, Manufactured component tracking, Parts register etc.
Should exhibit the ability to evaluate requirements for testability, design efficient test cases, and write extensive technical documentation.
Participate in the review of the product requirements, design requirements, software requirement specifications and functional specifications.
Assist in Risk management activities, Defect tracking, FMEAs and ensure compliance to standards and regulations.
Assist preparation for and conducting regulatory agency inspections.
Support engineering team in creating Design history files for new products for regulatory compliance.
Manage sterilization records and 3rd party validation processes
Support Quality manager to ensure quality system comply with CE, FDA regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Contributes to team effort by accomplishing related results as needed.
Performs other duties and responsibilities, as assigned
Role will report to Quality Manager.

Minimum of:

Bachelor of Engineering or technology degree with minimum 2 years experience in medical devices in QA or RA roles.
Freshers (BE/BTECH, Mechanical, Electrical, Electronics and communications) may apply, For freshers the first 6 months will be internship and on successful completion of internship the person may be offered a full time opportunity.
Knowledge of FDA/CE quality system requirements, ISO 13485 (Quality system) requirements, ISO 14971 (risk management) requirements, Medical device directives (MDD),knowledge of good manufacturing Practices (GMP),and applicable quality system standards
Knowledge of IEC EN 60601, Safety requirements for Medical electrical systems
Familiar with ISO 62304, Medical device software software Life cycle processes
Ability to analyze and interpret standards, technical procedures, professional journals and governmental guidance and regulation documents.
Understanding of sterilization validation and material biocompatibility
Understanding standing of Software, electrical and mechanical engineering principles.
Excellent verbal and written communication
Strong desire to be a part of a startup/high growth company with an entrepreneurial spirit and a fast paced, results oriented culture.
Hand-on Computer proficiency with knowledge of windows, office365, Microsoft office applications.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment

Proven track record in:

Maximizing Performance.
Driving best practice
Team work
Ability, confidence and knowledge to understand and challenge based on first principles.
Integrity

Vasmed Health Sciences Pvt. Ltd. is a Medical Devices research, development and manufacturing company based in Bangalore, and is a part of Vasmed Technologies, an ISO 13485 certified manufacturer of class III medical devices including implantable devices. Our new manufacturing unit in Bangalore is under commissioning.
We primarily focus on Interventional pressure sensing, intravascular imaging.