Quality Manager - Medical Device QMS and Controlled Environments

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

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.