Plant Quality Leader at BD Canada

Bawal, haryana, India -

Full Time

Start Date

Immediate

Expiry Date

19 Jun, 26

Salary

0.0

Posted On

21 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management System, ISO 9001, ISO 13485, Auditing, Quality Control, Microbiology Testing, Regulatory Compliance, Change Control, Process Validation, Root Cause Analysis, Corrective And Preventive Actions, Measurement System Analysis, FMEA, Sterilization Validation, Clean Room Testing, Customer Complaint Analysis

Industry

Medical Equipment Manufacturing

Description

Job Description Summary - To develop, implement, drive, sustain and continuously improve an effective Quality Management System for the Plant in line with BD WW norms, ISO, CE. Ensuring compliance to all quality assurance activities, regulatory and corporate requirements are complied with for all products manufactured in the Plant and release products which are compliant to above standards. - To build, implement, drive, sustain and continuously improve process validation and control capabilities for existing as well as new products to achieve product quality in compliance to BD’s Standards and Regulatory requirements in line with BD WW norms, ISO, CE. - To ensure that plant meets all needed regulatory compliance and continue to upgrade compliance standard Job Description Responsibilities include but are not limited to: Quality Assurance to enhance quality standards of plant 1. Ensure Development & maintenance of quality system for all aspects of plant operations including 1SO 9001, ISO 13485. 2. Assists with supplier and internal audits, as a means of evaluating the effectiveness of the established Quality Systems and Good Manufacturing Practices 3. Corporate Quality Audits Quality Control 1. Ensure on-time and effective testing of incoming material, in-process material and finished product 2. Ensure microbiology testing and quality testing for raw material, packaged material, assembled components, finished goods etc. and stability studies 3. Ensuring on time release of all products from plant 4. Ensure design & validate test methods for quality and microbiology testing 5. Ensuring lab practices are improved continuously in line with Good Laboratory Practices 6. Ensuring that Change Control process is followed for all material, process & product related changes. Regulatory Compliance 1. Ensure Corporate and regulatory compliance of the product 2. Ensure availability of new or renewed manufacturing license for products 3. Handling Regulatory inspection & certification from India as well as other countries/agencies 4. Ensure proper maintenance of batch records for products. Process Validation, Change Control, Sterilization Validation and Clean Room Testing 1. Supporting introduction of new product & processes by effective process validation and upgrading Bawal's Quality System to support new products. 2. Ensure Change Control process from initiation to end, till ECO release. 3. Ensure effective validation of manufacturing & test processes 4. Ensure implementation MSA (Measurement System Analysis) for CTQs. 5. Well conversant with Root Cause Analysis techniques. Facilitate route cause analysis for major process and product failures, implement effective and sustainable corrective and preventive actions. 6. Ensure Establishment and maintenance of product quality plan, control plan, process FMEA, validation or re-validation plan, product quality performance review and trending data for the processes and for continuous improvement efforts. 7. Ensure Validation / revalidation of sterilization 8. Ensure Validation / calibration of quality assurance equipment 9. Ensure Environment monitoring for clean rooms. Customer Complaint 1. Customer complaint Analysis, trending and adequate & timely redressal People development 1. Provide leadership and guidance to quality team 2. Ensure timely Performance Evaluation 3. Driving Team building and associate engagement initiatives 4. Develop validation capability for plant and leading VRB initiative Required Skills Optional Skills . Primary Work Location IND Rewari - Bawal Additional Locations Work Shift BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.

Responsibilities

The role involves developing, implementing, and sustaining an effective Quality Management System compliant with BD norms, ISO, and CE standards across all plant operations, including quality assurance, control, and regulatory adherence. Key duties include ensuring on-time testing, managing regulatory inspections, leading process validation efforts, and driving continuous improvement through techniques like Root Cause Analysis.