This position is responsible for leading and overseeing all quality assurance and quality control activities related to materials, components, and services supplied by external vendors to Pandora Production Vietnam.
Responsibilities
Develop, implement, and maintain effective Supplier Quality Management (SQM) processes and procedures, including Incoming Quality Control (IQC) guidelines, inspection plans, and material release protocols.
Supervise the Incoming Quality Control (IQC) team to ensure timely and accurate inspection, testing, and documentation of all raw materials, components (e.g., precious metals, stones, findings, packaging), and sub-assemblies.
Plan and conduct routine and focused quality audits of existing and potential suppliers (domestic and international) to assess their Quality Management Systems, manufacturing processes, and adherence to Pandora's Code of Conduct and quality specifications.
Lead the process of managing Non-Conforming Material (NCM) from suppliers. Drive rigorous Root Cause Analysis (RCA) and ensure the timely implementation and verification of effective Corrective and Preventive Actions (CAPA) by suppliers.
Establish, track, and report key supplier quality metrics (KPIs) such as Defect Rate (PPM), On-Time Delivery Quality, and Audit Score.
Requirements
Bachelor’s or Master's Degree in Engineering (Industrial, Mechanical, Materials, Chemical)
Science
Industrial Management
Nice to have: ISO 9001 Internal/Lead Auditor certification
This position is responsible for leading and overseeing all quality assurance and quality control activities related to materials, components, and services supplied by external vendors to Pandora Production Vietnam.
Responsibilities
Develop, implement, and maintain effective Supplier Quality Management (SQM) processes and procedures, including Incoming Quality Control (IQC) guidelines, inspection plans, and material release protocols.
Supervise the Incoming Quality Control (IQC) team to ensure timely and accurate inspection, testing, and documentation of all raw materials, components (e.g., precious metals, stones, findings, packaging), and sub-assemblies.
Plan and conduct routine and focused quality audits of existing and potential suppliers (domestic and international) to assess their Quality Management Systems, manufacturing processes, and adherence to Pandora's Code of Conduct and quality specifications.
Lead the process of managing Non-Conforming Material (NCM) from suppliers. Drive rigorous Root Cause Analysis (RCA) and ensure the timely implementation and verification of effective Corrective and Preventive Actions (CAPA) by suppliers.
Establish, track, and report key supplier quality metrics (KPIs) such as Defect Rate (PPM), On-Time Delivery Quality, and Audit Score. Use data-driven insights to manage and improve overall supplier quality performance.
Requirements
Bachelor’s or Master's Degree in Engineering (Industrial, Mechanical, Materials, Chemical), Science, or Industrial Management.
We seek a highly motivated Quality Engineer to support the design, development, and manufacturing of groundbreaking combination medical devices. The role involves leading investigations, reviewing product for release, and maintaining/im the quality management system.
Compensation
anticipated hiring pay range for this position $80,000 - $108,000 annually
Responsibilities
Lead the quality improvement projects within the quality system and manufacturing process
Lead quality efforts in implementation and continued maintenance within an eQMS
Lead investigation efforts within the NCR, CAPA, and Complaint processes
Perform root cause analysis and verify corrective actions
Review device history records for release
Requirements
Bachelor’s degree in biomedical engineering or a related field
Nice to have: Medical device experience
Nice to have: ASQ Certified Quality Engineer (CQE)
Ownership and execution of quality records including Deviations, CAPAs, Change Controls, and Analytical and Quality Control Investigations supporting cell manufacturing.
Compensation
Jr: $34-$38/hr, Mid: $48-$53/hr, Sr: $63-$67/hr
Responsibilities
Involved in deviation triage including coordination and investigational planning and event initiation
Identify and collaborate with SMEs for triage, determine immediate actions and containment, and document initial impact assessments
Lead investigation for manufacturing, QC, material, facility and equipment deviations including interviews, GEMBA using root cause analysis tools
Use root cause analysis tools to lead and write quality events in cell manufacturing, quality control, material operations and facility operations functional areas
Collaborate with subject matter experts on investigations to determine root cause and propose appropriate corrective and preventive actions
Leads the modernization and simplification of the Quality and EHS technology landscape, delivering reliable, scalable and validated solutions that enable operational quality, regulatory compliance, worker health and safety, environmental compliance, and GxP/CSV compliance.
Responsibilities
Define and own the global technology strategy and multi-year roadmap for enterprise Quality, EHS and Safety capabilities.
Establish strategic platform direction across electronic Quality Management Systems, manufacturing quality, laboratory quality systems, environmental health and safety, occupational health, and supporting data and analytics.
Drive simplification and consolidation of fragmented legacy technologies onto scalable enterprise platforms while protecting regulatory compliance and business continuity.
Establish investment priorities and ensure technology investments deliver measurable business, compliance and operational value.
Provide strategic leadership for enterprise quality platforms supporting document control, nonconformance, CAPA, complaints, investigations, audits, supplier quality and quality workflows.
Responsible for managing supplier quality, maintaining the electronic quality management system, and supporting medical device quality processes at the Mayflower Plant.
Compensation
The hourly rate range for this position is $24.67 - $43.16; the exact hourly rate depends on several factors such as experience, skills, education and budget.
Responsibilities
Manages supplier quality program to ensure risk evaluations, audits, quality agreements, and annual performance reviews are being completed as defined within our procedures across OVIK Health: RMC, Hatch, Salisbury, and Portsmouth
Acts as the primary Quality Point of Contact for critical suppliers
Manages supplier deviations and approvals
Manages and executes batch release activities for contract manufacturers
Execution of qualification activities (IQ/OQ/PQ) for manufacturing equipment, processes, and materials within Enterprise Quality – Change Management & Systems.
Responsibilities
Hands‑on execution role supporting equipment and process qualification activities within a manufacturing environment.
Draft, execute, and close out Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols for manufacturing equipment and systems.
Generate qualification reports, document results, and ensure full traceability of records in accordance with internal procedures and applicable regulatory requirements.
Coordinate closely on the factory floor with Manufacturing, Engineering, Quality, and Project teams to complete qualification testing around production windows.
Support documentation remediation, record management, and change‑control linkage for qualified equipment.
Support the full breadth of our QMS activities, including implementation of platforms such as an eQMS and an ERP system, continuous improvement of the QMS, supplier audits, and regulatory agency audits.
Locations (2)
Galway, Connacht, Ireland
Dublin, Leinster, Ireland
Compensation
Competitive package: market salary, bonus potential, company pension, private health insurance and more
Responsibilities
Project support for implementation of platforms such as an eQMS and an ERP system
Continuous improvement of the QMS (policies, procedures, change control, training) to support growth and regulatory compliance
Support complaint handling, CAPAs, NCRs
Development of quality plans, programs and procedures to support commercialisation, QMS activities, and product development
Ensure that performance and product quality conform to company, customer and regulatory requirements
The Senior Manager, Quality Systems & Compliance is responsible for administering, maintaining, and continuously improving Apnimed's electronic Quality Management System (eQMS) and associated quality processes, and for keeping them inspection-ready.
Locations (2)
Cambridge, Massachusetts, United States
United States
Compensation
$170,000.00 to $190,000.00
Responsibilities
Serve as subject matter expert and administrator for the electronic Quality Management System (eQMS), evaluating proposed system changes and coordinating testing, validation, and deployment activities.
Support the integration of new business processes, departments, and vendors into the Quality Management System, and oversee onboarding, knowledge transfer, and competency requirements for new eQMS administrators.
Maintain system documentation, including procedures, work instructions, validation documentation, and configuration records.
Administer the training program: confirm assignments and curricula reflect quality system responsibilities, manage role-based eQMS training and user support, and maintain a centralized library of user guidance, job aids, and FAQs.
Provide oversight and support for core quality processes, including document control, deviations, CAPAs, change controls, investigations, supplier quality records, and training management.
Requirements
Bachelor's degree or equivalent in a scientific, technical, engineering, quality, or related discipline
Nice to have: Veeva Quality
Nice to have: computerized system validation (CSV)
Nice to have: 21 CFR Part 11 compliance
Nice to have: development-stage pharmaceutical operations
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