Incumbent will be overall responsible for compliance as per MDD 93/42/EEC as amended by 2007/47/EC, ISO 13485:2016, ISO 9001: 2015, DCGI, Suppliers audit from several countries as per their local regulatory directives.
Incumbent will be actively engaged in transition from MDD to EU MDR of CE marked Drug Eluting Stents and will be responsible for adherence to the deadline.
Ability to take strategic direction and establish efficient and compliant processes throughout the organization and should have requisite communication and interpersonal skills to get them implemented.
Head Quality Assurance and lead QA team.
Develop, administer and maintain quality assurance procedures and activities required to ensure that the company's processes and products arein compliance to above mentioned directives
Employ quality assurance methodologies in support of engineering, manufacturing and regulatory functions.
Develop and implement quality control and inspection procedures for receipt and control of incoming materials, in-process materials and final product acceptance activities.
Define quality control standards and test; specify test equipment and procedures.
Coordinate and steer monthly product quality meetings.
Establish and maintain test instrument calibration procedures and maintenance schedules.
Establish quality assurance, quality control inspection and testing procedures.
Identify quality assurance metrics; analyze and report trends to management.
Review and responsible to withdraw non-conforming products and stop or released deliveries/shipments.
Active participant in all stages of design development, testing and design control activities, ensuring quality assurance considerations and requirements met.
Responsible for developing and maintaining sterilization validation and material biocompatibility activities.
Should exhibit the ability to evaluate requirements for testability, design efficient test cases, and write extensive technical documentation.
Participate in the review of product requirements, design requirements, software requirements specifications, and functional specifications.
Assist in Risk Management activities and ensure compliance to standards and regulations.
Assist in the failure investigation, product complaints and lead corrective and preventive actions.
Manage and steer the Quality Control team to ensure full compliance towards the Quality Management System, processes and procedures and alignment.
REQUISITE SKILLS:
Experience: Minimum 15 years in class III Medical Device, preferably from stent industry
QA, Quality Assurance, QMS, GMP.
Expert in MDD and upcoming EU MDR.
Team Building
Excellent communication skills
Strong organizational skills with a problem-solving attitude
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