10 - Manager, Operations Quality 2

Empresa : Celestica Tipo de empleo : Tiempo completo Monterrey, Mexico

Req ID: 137249

Remote Position: No

Region: Americas

Country: Mexico

State/Province: Nuevo Leon

City: Monterrey

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

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 .

• 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

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

The right Candidate for this position holds:

• 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 production equipment (IQ/OQ/PQ), and optimizing quality inspection parameters (Smart Inspection) .
• Strong leadership capability with a demonstrated history of expanding cross-functional team exposure and accelerating the development/coaching of personnel .
• Excellent technical writing skills for standardizing technical reports, addressing regulatory inquiries, and managing technical risk assessments (PFMEAs) .
• Sharp analytical, communication, and presentation skills to effectively interface during high-pressure regulatory audits

Experience: 10 + years of recent, progressive professional experience in Quality Engineering or Quality Operations, with a minimum of 5 years in a direct supervisory or managerial capacity managing technical contributors/engineers within the Medical Device field according to the responsabilites listed below:

Centralized Technical Authority: Provide strategic leadership and technical governance over Sterilization Assurance, Microbiology/Laboratory Services, and Technical Systems Engineering .

Proactive System Health: Deploy advanced Quality Engineering expertise to focus on automated release projects, standardized technical reporting, and system health metrics to aggressively reduce human error .

Risk De-risking: Lead engineering efforts to drive proactive Process Failure Mode and Effects Analysis (PFMEA) updates and provide immediate technical governance during site-critical manufacturing events .

Efficiency & Optimization: Champion \"Smart Inspection\" initiatives to increase operational efficiency across manufacturing lines without adding headcount

This job description is not intended to be an exhaustive list of all duties and responsibilities of the position. Employees are held accountable for all duties of the job. Job duties and the % of time identified for any function are subject to change at any time.

Bachelor of Science (B.S.) degree in Engineering (Biomedical, Chemical, Mechanical, or Electronics) or a hard scientific discipline (Microbiology, Biochemistry, or related Life Sciences field) or demonstrated equivalent experience.

Celestica is an equal opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against on any protected status (including race, religion, national origin, gender, sexual orientation, age, marit