Job Description
Role and Candidate Profile
Position Title: Manager - Quality Reporting to Group Quality Head
Management Systems of Central Quality
Team
Department / Operations / Quality Business Unit: Essilor India Pvt Ltd
Function: [EIPL]
Position Summary Purpose and Objectives of the Role
Lead and manage the Quality Management Systems [QMS] function for Essilor Greater India by
setting prescribed quality standards as per ISO 13485, processes and systems; follow regulatorily
compliances and quality controls; conduct periodic audits to ensure the products and services
are delivered within the prescribed medical standards.
Main Focus and Key Areas of Responsibilities
• Develop, establish and maintain quality systems as per ISO 13485 within the organization to
ensure that all necessary systems and procedures are in place to satisfy customer
requirements and audits
• Develop standard operating procedures for quality function. • Establish and maintain a document control system.
• Preparing & maintaining QMS documents like a quality plan, quality methods, control plan,
technical documents relevant to medical devices, Department procedures, etc.,
• Develop a change management and control system to ensure that all changes in the organization must comply with QMS requirements.
• Strictly adhered to Good Documentation Practices (GDP)/GQS & current Good Manufacturing
Practices (GMP); Knowledge of CE / USFDA regulations pertaining to Medical devices is an
advantage
• Develop, implement and manage key performance indicators (KPIs) for each area of
responsibility in alignment with medical devices standard ISO 13485
• Ensure that all in-house systems and procedures are updated, revised, and modified to meet
the needs of external certification bodies.
• Manage all external registration requirements to ensure they are met.
• Liaise with external bodies on all matters relating to registration with a focus to maintain and
improve quality standards, in line with business needs
• Ensure quality systems deliver cost-effective results at all stages and across all relevant
areas.
• Experience in handling Deviation, Nonconformance, Customer complaints (Root Cause
analysis & CAPA), Technical Support to customers for a medical device as per regulation
guidelines.
• Ensure corrective actions are undertaken to address nonconformities found. Verify closure
of non-conformities with Certification Bodies
• Experience in validation activities like IQ, OQ, PQ of medical device assembly machine /
products. Experience in risk assessment and implementation as per the standard EN ISO
14971.
• Experience in conducting periodic internal audits and management review meetings with
top management, proposing necessary resource requirements for implementing QMS in
the organization.
• Having experience in conducting internal, supplier qualification & preparing audit
compliance report for customer audit. Experience in Internal & External Calibration of
Measuring Instruments & Maintaining of Calibration Related documents.
• Assist work improvement teams to develop expertise in statistical and analytical methods
and tools; Knowledge in 8D report preparation, 7 QC tools, and training/ preparing the team
for implementing problem-solving tools are necessary.
• Undertake continuous training and development; Identify business improvement
opportunities within the organization
Candidate Profile Knowledge / Experience
Divisional or BU Operated as Specialist in Quality Management & Quality Control in a
Experience high volume manufacturing industry
Experience / Track
Record. Total 15 years of experience of which 8 -10 years of relevant
experience in handling QMS / Quality Assurance / Leadership role
in a reputed global manufacturing organization
Pre-requisites experience in terms of: -
hands-on experience in the implementation of QMS & having good
exposure on all relevant systems that are required for
implementing ISO 13485 in a medium / large volume manufacturing
environment.
. Experience should have been in a medium or high volume
manufacturing environment.
. Certified internal auditor for ISO 13485; Other ISO certifications /
Implementation experience is an advantage for this role.
. Experience with MS Word, MS Excel, Powerpoint, PC Tools &
laboratory instrumentation. Preferably a certified internal auditor for ISO 13485. Should have
Industries Experience One or more of the following:
. Medical device
. FMCG. Retail
Geographical
Experience. Must have experience in handling QMS / Quality Assurance /
Leadership role in a reputed global manufacturing organization management
Experience Quality Management Systems & Quality Control; regulatory
compliance, Audits as per ISO 13485; team management; Stakeholder management [Manufacturing, Supply and Essilor and external vendors and customers]
Qualifications
Education / . Bachelors Degree in Engineering (Mechanical / Industrial / Qualification / Production / Chemical)
Certification
Language Proficiency in English and local language. Multilingual will be
advantage.
Pre-requisites and Next Career Steps
Psychometrics/ . Demonstrates high energy and good communication skills
Behavioral Traits. Strong ability to influence, drive change amongst ambiguity
. Goal driven and result oriented with the 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