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Domestiko.Com; Valencia; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

Celestica, Inc. is seeking a Quality Manager to lead the Medical Device QMS alignment with ISO 13485 across Europe, ensuring regulatory compliance and seamless operations. The role includes updating quality documentation, supporting audits, and driving CAPA closures within controlled environments.

The successful candidate will oversee cleanroom operations, monitor critical systems, and coordinate environmental validation activities with external suppliers and internal teams.

Qualifications

• Bachelor's or Master's degree in Microbiology, Biology or a closely related science.
• 10+ years of proven, technical Microbiology/Lab Management in Medical Device.
• Deep regulatory knowledge: ISO 13485, ISO 14644, FDA 21 CFR Part 820.
• Strong background in sterilization and cleanroom validations.
• Fluent English; Spanish preferred for local collaboration.

Responsabilités

• Lead ISO 13485 QMS alignment across global and local procedures.
• Act as SME for ISO 13485; update docs and create compliant records.
• Support audits (corporate, ISO 13485, customer, FDA) with technical input.
• Drive CAPA/NCR/Excursion closure and root-cause analysis.
• Oversee cleanroom operations and controlled environments.
• Manage external supplier testing and environmental monitoring.
• Provide training and oversight for environmental validation URS/Protocols.

Connaissances

Quality management

Regulatory knowledge

Leadership

Audit readiness

Formation

Bachelor's or Master's Degree in Microbiology or Biology

Outils

Sterilization validations

Cleanroom validations

Description du poste

Quality Manager - Medical Device QMS and Controlled Environments

Req ID:
Remote Position: No
Region: Europe
Country: Spain
State/Province: La Pobla De Vallbona
City: Valencia

Key Responsibilities

Quality Management System (ISO 13485) & Global Alignment

• Corporate & Local Alignment: Lead the alignment and integration of ISO13485 QMS procedures with local facility procedures, ensuring seamless operational transitions and strict compliance.
• QMS Management: Act as a Subject Matter Expert (SME) for ISO 13485. Update Quality System Documentation and create new documents to align with regulations and Customer requirements.
• Audit Readiness: Participate in and provide highly technical support during third-party and regulatory audits (Corporate, ISO 13485, customers and FDA Inspections).
• Corrective Actions: Drive the follow-up, root cause analysis, and closure of CAPAs, NCRs, Excursions, and Quality Events.

Customer & Operations Quality Management

• Operations Quality Control: Oversee cleanroom and factory operations to ensure uninterrupted and compliant production.
• Customer Requirements: Effectively manage and fulfill requirements for both internal stakeholders and external clients.
• External Supplier Management for Cleanroom: Manage external supplier testing (including schedule and expense tracking) and outsourced laboratory testing (including sample shipments and expense control).

Environmental Monitoring & Cleanroom Controls

• Cleanroom Verification: Oversee cleanrooms and adjacent areas, ensuring strict verification of dress code, health, and hygiene.
• Critical Systems: Monitor Quality Parameters for Critical Systems and review/approve critical systems equipment calibrations.
• Facility Controls: Review trends and reports for pest control and general housekeeping to ensure controlled environments are not compromised.
• Validations & URS: Provide guidance, training and oversight for Environmental Validation including Protocols/Reports and the creation of URS for environmental controls.
• Biological Monitoring: Oversee Biological Testing Monitoring for applicable HealthTech/Medical Device products.
• Process Control: Monitor Cleaning Process Controls for applicable products
• Strelization Oversight and Certifications: Review/Approve sterilization reports and distribute Certificates of Conformance (CoC) and Sterilization Certificates to Customers.
• Shipping & Release: Monitor product shipment quality inspections and release to Sterilizers or Customer facilities. Manage the Final Product Release to the Customer Distribution Center

Qualifications & Requirements

• Education: Bachelor's or Master's Degree in Microbiology, Biology, or a closely related scientific discipline.
• Experience: Proven, extensive experience (10+ years) in a highly technical Microbiology/Lab Management role within the Medical Device industry.
• Regulatory Knowledge: Deep understanding and hands-on experience with ISO 13485, ISO-14644, FDA 21 CFR Part 820, and other relevant international standards.
• Technical Expertise: Strong background in sterilization validations, cleanroom validations, and microbiological lab controls.
• Leadership/Soft Skills: Demonstrated ability to align global corporate strategies with local execution. Excellent communication skills to interface confidently with external clients, internal teams, and regulatory bodies.
• Language: Fluent in English (written and spoken) for corporate alignment, technical documentation, and audit participation. Additional: Spanish preferred.

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.