ZEISS in India

ZEISS in India is headquartered in Bengaluru and present in the fields of Industrial Quality Solutions, Research Microscopy Solutions, Medical Technology, Vision Care and Sports & Cine Optics.

ZEISS India has 3 production facilities, R&D center, Global IT services and about 40 Sales & Service offices in almost all Tier I and Tier II cities in India. With 2200+ employees and continued investments over 25 years in India, ZEISS’ success story in India is continuing at a rapid pace. 

Further information at ZEISS India.

Purpose of this position/Position summary                                                                    

Implement, maintain and further develop the ZEISS India Management System, aligned with the Corporate ZEISS Man-agement System, maintain the ISO 9001 certification requirements, and the business requirements across the pan-India ZEISS organization.  Regulate, control and improve the quality of all processes throughout the business and the final product to meet the quality needs of our customers and other stakeholders.  Embed a culture of continuous improve-ment throughout the company.  Lead the team to achieve quality management system targets for customers and business goals.

Ensure company's products or services comply with all relevant regulations and standards. Act as a bridge between the company and regulatory agencies, navigating complex medical device industry regulatory  landscapes to bring products to market and maintain compliance.

Primary duties and responsibilities

Quality Management :

Lead the local development and implementation of management system procedures, systems and initiatives that continuously improve ZEISS systems and product quality levels, aligned with the ZEISS Management System.Responsible for quality related KPI’s, achievement of targets and driving improvements via the Quality team.Integrate quality activities with the Regional and VIS Quality Group and implement VIS requirements.Participate in Regional Quality Group forums, regional quality improvements and benchmarking initiatives.Coordinate with the local Customer Service groups to develop systems that are increasingly responsive to customer requirements and complaints and reduce product write-off levels and avoid further customer losses directly attributable to product quality.Ensure compliance with applicable product regulatory requirements and applicable National or ISO Standards.Responsible for maintaining external certification to ISO 9001, responsible for the internal audit program (system, process & product audits), including audits of other sites as lead or co-auditor, as well as hosting 3rd party & other external audits.  Liaise with external bodies on all matters relating to quality.Support New Product introductions and process optimizations. Coordinate product testing activities per Control Plans and Product Audits, and reporting to ensure new products or process changes meet specifications and customer requirements, Be the point person for collecting APQP protocols and report approvals and reports for site products in accordance with agreed procedures. Drive cost-down & improvement projects & initiatives, support the implementation of VIS group quality initiatives and tools.As representative of the customer at VIS, has the authority to stop deliveries and production in case of major product or system non-conformances, with approval / support of the Regional Quality Director or Head Group Quality Management, & aligning with local Management.Corrective and preventive actions using 8D or equivalent methods (from customer reports, audits, etc.).  Authority to request from other departments corrective actions in a timely manner.Work closely with all departments in ensuring timely & effective closeout of corrective actions, 8D investigations, nonconformance reports and customer complaints.Responsible for the local Quick Response Quality Control (QRQC) customer complaint system assuring investigation, complaint analysis and definition of the feedback information flow. Coordinate and control the communication with agreed communication channels in Commercial departments.

Regulatory Affairs

Ensure compliance with all products related regulatory compliances such as (not limited to): Medical device regulations of India and SAARC countries, Medical device regulations of all exporting countries, AERB compliances, Legal metrology compliances, WPC compliances, BIS certifications, MOEF compliances, Drug Sale License etc.Responsible for preparing the regulatory strategy for the organization and support the management to take appropriate decisions. Provides leadership and guidance (including training) to other members of the RA staff as well as to cross-functional team members and development teams. Design, establish and implement a standardized regulatory function processes across the organization. Independently interacts and builds good working relationships with competent authorities.Liaison with the regulator -drugs controlling authority/consultant for the registration of the products.Conducts regulatory due diligence, Identify the business risk and prepares the mitigation plan.Act as the contact person for internal and external regulatory inquiries, including ZEISS internal RA officer networks.Continuously monitor, gather, analyse, assess and communicate regulatory market requirements or changes for India and related local markets.

Dimensions  :

Leadership accountability

Leading and motivating employees and functions assigned in technical terms, in order to achieve the set targets with all those involved.Ensure the delivery of the People Strategy within area of accountability.Manage and lead the team, ensuring adequate staffing levels.Motivate and coach the team to operational success.Monitor the completion of tasks and ensure good performance and record on appropriate systems.Consistently promote high standards through personal example and roll-out through the team so that each member of the team understands the standards and behaviors expected of them.Review, implement and update company records e.g. training matrices, performance reviews, risk assessments.Communicate KPIs from the strategic annual plan so that each employee is aware.Provide technical expertise to the team.Manage contractors on site to ensure they meet legal and company requirements.

Supervisory dimension

Manage, coach and develop a high performing Quality, Regulatory and Process Excellence team that meets agreed objectives, and which delivers best practice results, added value and continuous improvements.

Key relationship/customers

Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance.Work collaboratively, negotiate and engage with key stakeholders to facilitate delivery and compliance with the quality strategy.Liaise and communicate with other departments, customers, suppliers and other service providers.Work as part of the Management team to share ideas and improve operation, recommending, supporting and implementing continuous improvement activities and process and procedure improvements to optimize results and improve quality of delivery, in line with quality standards requirements delivery in line with Company and Customer requirements.Communicate with personnel at all levels, internally and externally to the Company, in relation to Quality matters.

Key interfaces/liaison/functional guidance within ZEISS group

Work closely with Operations, Supply chain, Procurement, Supplier Quality, etc.Support local and global post-market surveillance activities and clinical evaluation.Responsible for the coordination or escalation of critical incidents in the Region and reporting to the regulatory authorities.Provides support for any recall management, RA related complaints management and resulting measures.Support R&D team and digital innovation team to comply with the regulatory requirements.Assists with audits and inspections, if required.Responsible to do the new product assessment and change impact assessment.Obtain a drug license for the distribution of the medical device. Ensure compliance to the Drug sale license or MD42 requirements at all.

1.    Education / Professional Certification

Master / bachelor’s degree in science, engineering, business or optical field preferredLead auditor certification in ISO 13485 / ISO 9001(Optional)Lean Six sigma green belt certified or trained (Optional)

2.    Experience

At least 10 years experience in working with Quality Assurance and Regulatory affairs in a manufacturing industry. Experienced in Lens manufacturing or medical device Quality and Regulatory management.  Should have good experience is leading, mentoring, and guiding the team. Should have a good knowledge and understanding of MSA, APQP, QRQC, 8D, PCP PFMEA, SPC etc.In-depth understanding of medical device regulations which includes but not limited to the followings, the Drugs & Cosmetics Act, the Drugs & Cosmetics Rules, the Medical Device Rules, The Legal Metrology Act and Rules.Sound knowledge of international laws, standards, and regulations for licensing medical devices and of the business processes of medical device manufacturers/import/ sale (e.g., India MDR 2017, MDD/MDR,)Good understanding of Six Sigma methodology and have a mind set of systematic approach to all problems. Good proven experience in conducting management system audits. Experienced in dealing different stake holders and having good communication skill.Advanced written and verbal communication, computer, analytical problem-solving skills are necessary.Demonstrated ability to drive change in a complex and dynamic environment and have ability to solve complex problems within the manufacturing set up.

3. Knowledge / Skills / Other characteristics

MS Office, SAP, Minitab, SharePoint, PowerBI, Visio 

 

Your ZEISS Recruiting Team:

Jayashree V