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) & General 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 pr

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