Asst. Manager / Dy. Manager - Quality Control
Molbio Diagnostics is hiring a Quality Control Manager to oversee QC operations in a regulated medical device manufacturing environment. The role involves leading the QC team, managing inspection and testing procedures, and ensuring strict adherence to global regulatory standards like FDA, ISO 13485, and EU MDR. The candidate will be responsible for quality documentation, internal audits, and maintaining data integrity according to GDP standards. This position requires deep expertise in quality control methodologies and a strong background in team leadership.
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Experience
8-10 years
Function
Quality Assurance
Work mode
Onsite, India
Company
Tier 2
What you will work on
Molbio Diagnostics is hiring a Quality Control Manager to oversee QC operations in a regulated medical device manufacturing environment. The role involves leading the QC team, managing inspection and testing procedures, and ensuring strict adherence to global regulatory standards like FDA, ISO 13485, and EU MDR. The candidate will be responsible for quality documentation, internal audits, and maintaining data integrity according to GDP standards. This position requires deep expertise in quality control methodologies and a strong background in team leadership.
TAL's take
Solid mid-tier healthtech company with a clear and well-defined managerial role in a critical quality function.
The JD is crisp, defining specific responsibilities across leadership, technical oversight, regulatory compliance, and documentation.
Must haves
- 8-10 years experience in quality control
- Medical device manufacturing environment experience
- 2-3 years in a leadership or managerial role
- Knowledge of FDA and ISO 13485 standards
- Familiarity with statistical sampling and SPC
Tools and skills
About the company
Established medical diagnostics company, though not a top-tier tech unicorn.