Req ID: 137249
Remote Position: No
Region: Americas
Country: Mexico
State/Province: Actual Leon
City: Monterrey

General Overview:
Functional Area: Quality (QUA)
- Career Stream: Operations Quality (OPQ)
- Role: Manager 2 (MG2)
- Job Title: Manager, Operations Quality 2
- Job Code: MG2-QUA-OPQ
- Job Level: Level 10
- Direct/Indirect Indicator: Indirect

Summary:
Position Summary:
We are seeking a highly technical, strategic Quality Technical Services (QTS) Hub Manager (Band 10) to lead our newly centralized technical quality command. This critical leadership role uncouples deep technical engineering investigations from day-to-day administrative burdens. You will directly oversee high-risk, high-impact manufacturing and regulatory support pillars, shifting the site toward a proactive system health model.

Physical Demands:
- Must be able to access and move safely within cleanroom environments, microbiology laboratories, and manufacturing production lines.
- Standard office environment tasks, including extended periods of sitting, computer line-of-sight operations,



and collaborative cross-functional reviews

Knowledge/Skills/Competencies:
Mandatory Qualifications & Background:
- Regulatory Compliance: Proven, deep hands-on expertise operating within ISO 13485 certified and FDA-registered facilities.
- Domain Competencies: Demonstrated on-the-job experience across critical quality pillars including: Sterilization Assurance, Environmental Control/Microbiology, New Product Introduction (NPI), Project Management, Quality Management Systems (QMS), Continuous Improvement (CI), CAPA Management, Advanced Process Controls, Internal/External Regulatory Audits, Customer Complaints Management, Quality Core Tools (PFMEA, SPC, MSA, PPAP), and strategic Personnel Development

Detailed Description:
- Advanced knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 11135 / 11137 (Sterilization standards).
- Proven track record of managing automated product release projects, validating pro

📌 10 - Manager, Operations Quality 2 (Monterrey)
🏢 Celestica
📍 Monterrey