QMS Manager

Role and Candidate Profile
Position Title: Assistant Manager / Deputy Reporting to: Lab Manager and Head of
Manager - Quality Quality Department / Function: Operations / Quality Business Unit: EIPL
Position Summary Purpose and Objectives of the Role
The regional quality manager will have to operationalize and manage the Quality function for the assigned laboratory
by setting prescribed quality standards as per ISO 13485, processes, and systems; follow regulatory compliances
and quality controls; conduct periodic audits to ensure the products and services are delivered within the prescribed
medical standards.
Key Areas of Responsibilities
Responsible for the following business / functional activities of India business unit:
• Understand customer needs and requirements to develop effective quality control processes
• Devise and review specifications for products or processes
• Lead QMS system in the organization and ensure compliance of the system
• Create, review, revise and maintain quality documentation such as Quality manuals, Quality procedures,
SOP, formats etc of all the inter departments
• Lead and conduct Improvement activities to enhance the Quality management systems
• Interfacing production, technical and other interrelated departments to ensure products, processes comply
with all relevant requirements of QMS
• Preparing audit plans, conduct audits, creating audit findings reports, including closing the audit findings
through CAPA by proper corrective and preventive actions.
• Conduct Management review meetings along with the top management & all HODs
• Analyzing failures, corrective actions, and preventive actions to respond to the customer complaints if any
• Coordinate with production and technical team on executing Risk assessments & its closure
• Direct changes in process or product to ensure timely execution of Change managements
• Management of IQ, OQ, PQ validations and management of its records
• Assists all inter departments in standardization and simplification of documentation, records management
and better document control to have smooth work flow
• Prepare plan and execute trainings related to QMS system in the organization.
• Set requirements for raw material or intermediate products for suppliers and monitor their compliance
• Oversee all product development procedures to identify deviations from quality standards
• Inspect final output and compare properties to requirements
• Keep accurate documentation and perform statistical analysis
• Solicit feedback from customers to assess whether their requirements are met
• Submit detailed reports to appropriate executives
• Be on the lookout for opportunities for improvement and develop new efficient procedures
Candidate Profile
Knowledge / Experience
Divisional or BU
Experience Operated as Specialist in Quality assurance and quality control in a high volume
manufacturing industry.Experience / Track
Record • Total 10 years of experience of which 7-8 years of relevant experience in
Quality Function for a manufacturing company
• Work exposure in a multi-national environment.
• Qualified as an internal auditor/successful completion/certification on ISO
13485:2016
• Must have basic Quality Management tools exposure (lean Six sigma,
Continuous Improvement tools problem solving, statistical process control)
• QMS experience on ISO 13485: 2016 preferable

• Experience in handling customer complaint and resolution. • Proficient in (MS Word, Excel and PowerPoint).
  • A keen eye for detail and a results driven approach
  • In depth understanding of quality control procedures and relevant legal
  standards
  • Excellent math abilities and working knowledge of data analysis/statistical
  methods
  • Good communication and presentations, Collaborative with strong
  interpersonal skills Industries Experience One or more of the following:
  Medical device Pharmaceuticals
  Geographical Experience Must have India market experience, APAC or beyond collaboration experience will be
  an advantage.
  Management Experience Quality Management Systems & Quality Control; regulatory compliance, Audits as per
  ISO 13485; team management; Stakeholder management Qualifications
  Education Bachelors degree in Engineering (Mechanical / Industrial / Production / Chemical)
  Language Proficiency in English and local language. Multilingual will be an advantage. Pre-requisites
  Psychometrics/ • Demonstrates high energy and good communication skills Behavioural Traits
  • Strong ability to influence, drive change amongst ambiguity
  • Goal driven and result oriented with flexibility to work in challenging situations
  • Clear and fact based decision making
  • Diverse and able to work well in teams and across functions
  • Strong analytical and problem solving skills are necessary
  • Interpersonal & team management skills