08 - Specialist, Operations Quality

Req ID: 140070 
Remote Position: No
Region: Europe 
Country: Romania 
State/Province: Oradea 
City:  Oradea 

General Overview

Functional Area: Quality (QUA)
Career Stream: Operations Quality (OPQ)
Role: Specialist (SPE)
Job Title:   Specialist, Operations Quality
Job Code :  SPE-QUA-OPQ
Job Level: Band 08
Direct/Indirect Indicator: Indirect

Summary

We are hiring a Quality Specialist (Medical / Health Tech) to manage customer quality specifications, Quality Management System (QMS) requirements, and process validations, reporting directly to the Quality Manager.

The Quality Specialist leads quality planning for the Health Tech (HTC) medical segment, drives continuous process improvements, reviews validation protocols, and oversees quality data reporting to ensure high customer satisfaction . This role may also lead working groups or project teams of technical and support staff .

Detailed Description

Performs tasks such as, but not limited to, the following:

NPI & Quality Planning: Lead quality onboarding for new HTC customers and New Product Introduction (NPI) activities, including First Article Inspections (FPA/First Item Reports), PPAP documentation, and Control Plans.

Documentation & Change Control: Create, review, and update work instructions, SOPs, and process documentation. Manage Engineering Change Notifications (ECN) and Process Change Notifications (PCN) in line with ISO and FDA regulations.

Audits & Compliance: Act as lead auditor for internal, process, product, system, supplier, 5S, safety, and regulatory compliance audits.

Data Analysis & Reporting: Collect and analyze quality KPIs (scrap rates, process yields), prepare Quarterly Business Review (QBR) reports, and present data to internal and external stakeholders.

Issue Resolution & Risk Management: Lead root cause analysis, CAR/SCAR, and corrective/preventive actions for customer complaints. Coordinate the Material Review Board (MRB) and Return Material Authorization (RMA) processes, while managing PFMEA and ESD/MSD compliance.

Team Leadership & Mentorship: Establish annual objectives, assign tasks, evaluate performance, and provide technical training to quality technicians and engineers.

Knowledge/Skills/Competencies

• Solid expertise in ISO 9001, ISO 13485, ISO 19011, ISO 14001, ISO 50001, ISO 14971, and FDA CFR rules (such as CFR 820/821) .

• Proficient in MS Office, Statistical Process Control (SPC), PFMEA, 8D methodology, Control Plans, and process validation . Lean Six Sigma and supply chain/inventory management knowledge are strong advantages .

• Advanced English language skills, strong analytical capabilities, effective communication skills.

Physical Demands

• Duties of this position are performed in a normal office environment.
• Duties may require repetitive manual movements (e.g., keyboarding), carrying, pushing or pulling light objects, (under 5 kg.), carrying, pushing or pulling heavy objects (over 5 kg.), crouching, climbing
• Sustained visual concentration on small areas, such as monitors, screens, precise eye/hand coordination, sustained visual concentration on numbers, legal documents

Typical Experience

• 4 to 6 years in a similar role or industry.

Typical Education

• Bachelor's degree in related field, or consideration of an equivalent combination of education and experiency.
• Educational requirements may vary by geography.

Notes

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.

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, marital status, veteran or disability status or other characteristics protected by law).
At Celestica we are committed to fostering an inclusive, accessible environment, where all employees and customers feel valued, respected and supported. Special arrangements can be made for candidates who need it throughout the hiring process. Please indicate your needs and we will work with you to meet them.

COMPANY OVERVIEW:

Celestica, Inc. (NYSE: CLS; TSX: CLS) is a technology leader dedicated to driving customer success and market advancements. With deep expertise in design, engineering, manufacturing, supply chain, and platform solutions, Celestica enables critical data center infrastructure for AI, cloud, and hybrid cloud and advances technologies in high-growth markets. With a talented team and a strategic global network, Celestica helps its customers achieve competitive advantages.

Today, Celestica delivers innovative supply chain solutions globally to customers in strategic two operating and reporting segments:  Advanced Technology Solutions (ATS) and Connectivity and Cloud Solutions (CC):

ATS: This segment serves customers in complex, regulated and high-reliability markets such as Industrial & Smart Energy, Aerospace & Defense, Semiconductor Capital Equipment, and HealthTech. It is engineering led, with deep expertise in design, manufacturing and lifecycle solutions.

CCS: This segment focuses on high-performance technology solutions and services for the data center, serving hyperscalers, digital native customers and enterprises. Celestica's Platform Solutions offering provides innovative and customizable computing, storage and networking solutions enabling AI-driven growth.

Built on a legacy of trust and performance, Celestica has earned its reputation by delivering results in complex and fast-changing markets. Celestica exceeds customer expectations by identifying trends and staying ahead of the curve. Backed by comprehensive capabilities and a global network across North America, Europe and Asia, Celestica helps customers gain competitive advantage with the quality, flexibility and resiliency they need to respond quickly to shifts in demand. Guided by a bold vision to accelerate market advancements, Celestica delivers innovative solutions and technologies that turn complexity into opportunity. Anchored in teamwork and commitment, Celestica strives to be the most trusted partner to its customers and colleagues worldwide.

Celestica would like to thank all applicants, however, only qualified applicants will be contacted.
Celestica does not accept unsolicited resumes from recruitment agencies or fee based recruitment services.