Head - Quality & Regulatory

Hi,

We are hiring for Head -Quality & Regulatory | Bangalore Location.

Job purpose

Implement, maintain and further develop the ZEISS India Management System, aligned with the Corporate ZEISS Management 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 improvement throughout the company. Lead the team to achieve quality management system targets for customers and business goals.

Main Accountabilities

Quality Management :

1. 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 & SBUs: principally Vision Care and IQS.

2. Responsible for quality related KPIs, achievement of targets and driving improvements via the Quality team.

3. Integrate quality activities with the Regional and VIS Quality Group and implement VIS requirements.

4. Participate in Regional Quality Group forums, regional quality improvements and benchmarking initiatives.

5. 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.

6. Ensure compliance with applicable product regulatory requirements and applicable National or ISO Standards.

7. 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.

8. Support New Product introductions and process optimizations. Coordinate product testing activities per Control Plans and Product Audits, and report 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.

9. Drive cost-down & improvement projects & initiatives, support the implementation of VIS group quality initiatives and tools.

Regulatory Affairs

1. 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.

2. Responsible for preparing the regulatory strategy for the organization and supporting the management to take appropriate decisions.

3. Provides leadership and guidance (including training) to other members of the RA staff as well as to cross-functional team members and development teams.

Education requirements / Experience / Job Specifications :

1. Education / Professional Certification

• Master / bachelors degree in science, engineering, business or optical field preferred.

• Lead 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.