Senior Quality Manager
The Quality Manager at Bio-Rad Laboratories will lead quality management systems for their Singapore manufacturing site, focusing on MDSAP and ISO 13485 compliance. The role involves overseeing a team, collaborating with cross-functional global sites, and serving as the primary representative during regulatory audits. Candidates must have extensive experience in regulated medical device environments, statistical methods, and ERP/PLM systems. This position offers a key leadership role in ensuring high-quality standards within a global healthcare leader.
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Experience
12+ years
Function
Quality Assurance
Work mode
Onsite, Singapore
Company
Tier 2
What you will work on
The Quality Manager at Bio-Rad Laboratories will lead quality management systems for their Singapore manufacturing site, focusing on MDSAP and ISO 13485 compliance. The role involves overseeing a team, collaborating with cross-functional global sites, and serving as the primary representative during regulatory audits. Candidates must have extensive experience in regulated medical device environments, statistical methods, and ERP/PLM systems. This position offers a key leadership role in ensuring high-quality standards within a global healthcare leader.
TAL's take
Solid role at a well-regarded global life sciences firm with clearly defined leadership and regulatory responsibilities.
The JD is very clear about the regulatory frameworks (MDSAP, ISO), team leadership expectations, and the manufacturing domain.
Must haves
- 12+ years of experience in a regulated environment
- Experience implementing MDSAP and ISO 13485
- Experience hosting regulatory inspections
- Minimum 2 years experience with ERP systems
- Supervisory experience
- Experience in medical device quality systems
Tools and skills
Nice to have: six sigma green belt, six sigma black belt, iso 13485 lead auditor.
About the company
Established global life sciences company with a strong reputation, but does not fit the specific tier 1 tech-sector criteria.
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