Accumax Lab Devices Pvt. Ltd. Seeks a Talented Management Representative (QMS Head)!
Are you a quality champion with a passion for biopharma equipment and a keen eye for detail Do you thrive in a dynamic environment and enjoy fostering collaboration across teams If so, Accumax Lab Devices wants YOU!
Accumax Lab Devices, a leading innovator in the medical device industry, is seeking a highly motivated Management Representative (QMS Manager) to join our growing team. In this critical role, you will play a pivotal role in ensuring the integrity and effectiveness of our Quality Management System (QMS) across all Accumax Group locations.
Key Responsibilities:
- Lead QMS Development & Implementation: Collaborate with the QMS Manager to develop, implement, and meticulously maintain comprehensive group-level QMS procedures and documentation, adhering strictly to relevant regulatory standards (e.g., ISO 13485, GMP, FDA QSR).
- Champion Quality Excellence: Partner with teams across Accumax locations to create, update, and manage quality manuals, procedures, and records, fostering a culture of quality excellence throughout the company.
- Drive Continuous Improvement: Collaborate with cross-functional teams (R&D, Sales) to establish clear SOPs and integrate best practices in quality management across all departments.
- Content Creation Expert: Contribute to the creation of high-quality technical content that meets stringent QMS documentation standards for the entire Accumax Group.
- Stay Ahead of the Curve: Remain current on industry trends, technological advancements, and regulatory shifts impacting quality management in medical devices.
- Knowledge Sharing & Training: Facilitate staff training on QMS standards, best practices, and the importance of meticulous documentation.
- Continuous Improvement Advocate: Champion a culture of KAIZEN (continuous improvement) by assisting with KPI analysis and identifying areas for enhancement in QMS effectiveness across the organization.
- Active Participation: Actively participate in QMS meetings, providing valuable insights to the QMS Manager.
Harmonization of Quality Processes: Lead efforts to harmonize quality documents and processes across all Accumax Group companies, ensuring consistency, efficiency, and a streamlined approach to quality management.
About You:
- Degree in a relevant field (Biomedical/Biotechnology Engineering, Pharmaceutical Engineering, or similar science discipline).
- 5-6 years of experience in a quality-related role within the Biopharmaceutical Industry, with a specific focus on biopharma equipment.
- Strong understanding of Quality Management Systems (QMS) principles and their practical application in a biopharmaceutical environment.
- Familiarity with relevant regulatory standards (e.g., ISO 13485, GMP, FDA QSR, ISO 9001, 14001, 45001).
- Working knowledge of biopharmaceutical manufacturing processes and associated quality control procedures.
- Experience with risk management principles in a biopharma setting is a plus.
Additional Skills:
- Keen eye for detail and unwavering commitment to accuracy in QMS documentation.
- Excellent communication (written & verbal) to foster collaboration across departments and locations.
- Proficiency in MS Office Suite (Excel, Word, PowerPoint) and internet research tools.
- Strong desire to learn and grow within a fast-paced and dynamic environment.
Ready to join a team that's passionate about quality and innovation We offer a competitive compensation package and a stimulating work environment. Submit your resume to [Confidential Information] today!
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