Supports the Quality Assurance Manager in maintaining an effective Quality Management System (QMS) by emphasizing internal audit execution and third-party audit coordination.
Responsibilities
Support development and maintenance of the annual internal audit schedule in alignment with QMS requirements.
Perform internal audits of processes, procedures, and departments under guidance of Lead Auditor or QA Management.
Prepare audit plans, checklists, and supporting documentation based on AS9100, ISO9001, regulatory, and internal requirements.
Document audit results clearly, including objective evidence, nonconformities, and observations.
Track audit findings and support timely closure of corrective actions.
Requirements
Associate’s or Bachelor’s degree in Quality, Engineering, Business, or related field
Nice to have: Aerospace experience
Nice to have: Internal or external audit support
Nice to have: ASQ Certified Quality Auditor (CQA)
Nice to have: Lead Auditor training (AS9100/ISO9001)
Manage and coordinate cross‑functional project portfolios for Laboratorios Grifols, ensuring effective planning, execution, and alignment with quality and business objectives.
Responsibilities
Maintain a consolidated project portfolio
Monitor project progress and risks
Define governance standards and reporting
Coordinate project teams and meetings
Manage requests, deliverables, approvals and communications
Requirements
Bachelor's degree in Science, Engineering, Pharmacy, Biotechnology or a related field
Support a state of high-quality performance, compliance, and oversight/performance monitoring of Philips manufacturing processes, driving compliance and continuous improvement throughout the manufacturing process.
Compensation
The pay range for this position in Bedford, MA is $102,480 to $163,968.
Responsibilities
Support operations performance monitoring, reporting, improvement and development, facilitate quality improvement programs in factories.
Handles nonconformance events/investigations in the factory, leverages PFMEA to assess risk, guides material review board activities for non-conformance disposition management, leads analysis of defects for determining dispositions of non-conformances, drives management of Non-Conformances (NC) and facilitates implementation of effective Corrective and Preventive Actions (CAPA) actions.
Facilitates timely quality engineering and quality assurance tasks, ensures manufacturing quality systems are maintained, handles single or complex process validation and process improvement activities, and helps in completion of New Product Introduction (NPI) and product transfers in factory.
Leads validation protocols, facilitates production builds to support validation activities, analyzes data for reports, process improvement initiatives, and validation activities.
Utilizes advanced statistical analysis methods to interpret complex data trends, resolve a wide range of moderate complexity requests, and provide strategic insights to drive advanced improvement initiatives and ensure regulatory compliance.
Lead supplier quality management activities, ensuring compliance with ISO 13485, ISO 9001, MDR and FDA requirements, and driving continuous improvement through CAPA, PPAP and supplier performance metrics.
Responsibilities
Track supplier-related raw material and material non-conformities through to closure
Coordinate supplier CAPA processes end-to-end
Support supplier quality and procurement audits
Clarify responsibilities, action items, and target deadlines across cross-functional teams
Conduct quality alignment meetings and technical correspondence with suppliers
Requirements
Bachelor’s degree in Engineering, Sciences, or a related discipline from an accredited university
Management of customer claims across the region combining quality engineering rigor with claim coordination excellence, advising Business Lines on design improvements arising from recurring failure patterns.
Compensation
Competitive compensation and a global incentive program tied to business and performance targets
Responsibilities
Lead the end-to-end technical management of customer claims across the South America region, from claim intake through root cause analysis, CAPA implementation, and case closure.
Perform technical failure investigations using dimensional, material, and metallurgical evidence to identify failure modes and validate root causes in collaboration with Plant Engineering teams.
Own and drive Root Cause Analysis (RCA) activities utilizing structured methodologies such as 8D, Ishikawa, and 5-Why, ensuring robust corrective and preventive actions are implemented.
Manage the execution and follow-up of CAPA actions, monitoring progress, ensuring SLA compliance, and verifying effectiveness before case closure.
Conduct technical reviews of warranty claims, validating engineering justification and failure analysis before financial approval is granted.
Seeking a motivated and hands-on Maintenance Technician to coordinate and execute maintenance, calibration, utilities, and facilities activities in a regulated environment (cGMP, FDA, EU regulations).
Responsibilities
Coordinate and execute daily facilities, maintenance, and engineering activities across the site.
Ensure the timely completion and accurate documentation of preventive and corrective maintenance work orders within SAP.
Support the reliable operation of technical systems, utilities, facility equipment, building services, and security systems.
Ensure maintenance and engineering activities comply with cGMP requirements, site procedures, and regulatory standards.
Assist in establishing and maintaining preventive maintenance programs for technical equipment, facilities, utilities, grounds, and pest control systems.
Lead GCP auditor responsible for risk‑based audits, inspections, and quality initiatives across global QA organization.
Locations (2)
Durham, North Carolina, United States
United States
Compensation
Pay Range: USD $70,000-$125,000
Responsibilities
Conduct and lead risk‑based, end‑to‑end GCP audits, including process, service provider/vendor, clinical investigator site, study, and for‑cause audits.
Provide GCP subject matter expertise and regulatory guidance to internal stakeholders, project teams, and clients, including client‑ and regulatory authority‑facing support as appropriate.
Coordinate and host sponsor qualification and routine audits, regulatory inspections, for‑cause audits, and other external audit activities.
Serve as a primary QA point of contact throughout the audit and inspection lifecycle, supporting readiness, request management, document and system access, SME and interview coordination, and issue escalation.
Responsible for planning, executing, and reporting internal audits to maintain and improve the Quality Management System (QMS) across laboratory and business operations.
Locations (2)
Sandyford, Leinster, Ireland
Dublin, Leinster, Ireland
Responsibilities
Conduct and report internal audits across operational, laboratory, technical, and support functions
Evaluate effectiveness of quality management systems and assess compliance with ISO 15189:2022 and ISO 9001:2026
Participate in implementation and maintenance of the QMS
Identify non-conformities and drive corrective and preventive actions
Gather and evaluate objective evidence through interviews, document reviews, observations, and data analysis
Requirements
Bachelor’s degree in Life Sciences, Biomedical Science, Quality Management, Healthcare, or a related discipline
Lead the development and execution of strategic initiatives to enhance patient access through Risk Evaluation and Mitigation Strategies (REMS).
Locations (2)
Radnor, Pennsylvania, United States
South San Francisco, California, United States
Compensation
In the U.S., the hiring pay range for fully qualified candidates is $220,500-$257,250 per year.
Responsibilities
Align patient services initiatives with REMS requirements, organizational goals, compliance standards, and market access strategies.
Manage REMS compliance, audit readiness, and reporting.
Lead end-to-end REMS program strategy and operations, ensuring regulatory compliance while optimizing patient access, provider experience, and program effectiveness.
Oversee REMS operational workflows, audit readiness, and reporting; support launches, updates, and lifecycle management of REMS programs.
Lead the operational data gathering, analysis, and narrative development for REMS Assessment reports.
Facilitate and review audit and inspection responses, including assessment and challenge of responses, corrective actions, and CAPAs to ensure they adequately address reported observations.
Requirements
Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
Nice to have: postgraduate degree (MSc or equivalent)
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