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SalaryCompetitive SalaryLocationDehra DūnIndustryPharma, Biotech, Healthcare & Medical DevicesJob Description
- Designation: HEAD - QUALITY ASSURANCE
- Location: Dehradun
- Reporting To: Manufacturing Head
- Industry: Medical Device
- 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.
- 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