Director, Quality Assurance and Vigilance
Fresenius Kabi, North Andover, MA, United States
Director Of Design Assurance & Site Quality
The Director of Design Assurance & Site Quality is the senior quality leader for the Design Center and responsible for leading and developing the local Quality organization. This role leads the local Quality organization, owns and maintains the Design Center's QMS, and serves as the Site Quality Management Representative. As the owner of Design Quality, the Director ensures that all products developed at the site meet applicable regulatory, compliance, safety, and performance requirements throughout their lifecycle. The role provides leadership in Design Controls, Risk Management, DfX, Design Assurance, Design Transfer, Supplier Quality, Technical Documentation, and Audit/Inspection Readiness. The Director ensures design robustness, manufacturability, and continuous improvement, while also: Ensuring adequate technical support to Post Market Surveillance, field performance investigations, and manufacturing issues for all products designed at the center Ensuring Design Controls and Risk Management are implemented effectively and consistently Ensuring the site is continuously prepared for FDA inspections, Notified Body audits, and internal audits The Director ensures that product designs are safe, effective, manufacturable, and compliant throughout their lifecycle, and that quality culture and performance meet MedTech standards. This leader is a key member of the Design Center Management Team and the BU Quality Leadership Team, collaborating cross functionally with R&D, PMS, Regulatory Affairs, Manufacturing Sites, Supplier Quality, and Market Units across the MedTech business. Salary Range: $185,000-$205,000 Position is eligible to participate in a bonus plan with a target of 16% of the base salary (include only if applicable to the grade level) Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Hybrid role: Onsite Tues, Wed, Thurs Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future. Responsibilities include: Leadership & Organizational Management Appointed as Management Representative for the North Andover Design Center with responsibility and authority Lead the site Quality organization, including Design Assurance, Quality Systems, Compliance, and related functions. Quality Management System Ownership (Site QMS & QMR Role) Ensure processes required for the QMS are defined, documented, implemented, and maintained. Ensure awareness and understanding of applicable regulatory, customer and quality requirements across the site. Report regularly to top management on QMS performance, risks, and improvement needs. Maintain site certification(s) and compliance with ISO 13485, MDR, FDA QSR/QMSR, ISO 14971, and any other applicable standards. Lead site readiness and execution for FDA inspections, Notified Body audits, corporate audits, and internal audits. Oversee document control, training effectiveness, internal audit program, CAPA system, change control, and management reviews. Drive continuous improvement, implementing best practices and harmonization across MedTech where relevant. Design Assurance (Full Design Controls Ownership) Own and ensure effective implementation of Design Controls (FDA 820.30 / ISO 13485 7.3). Oversee: Design planning, inputs / outputs, and reviews. o Verification & Validation o Design transfer and Design changes Ensure products are designed for safety, efficacy, quality, manufacturability, usability, and compliance. Ensure comprehensive application of ISO 14971 Risk Management, including risk file maintenance and post market risk evaluation. Provide independent Quality approval for design deliverables and design changes. Ensure design documentation meets FDA 820.30, MDR Annex II/III, and global regulatory expectations. Ensure usability engineering (IEC 62366) and software lifecycle considerations (IEC 62304), where applicable, are integrated. Participate in and/or chair design governance bodies such as CCB, PRM, and design reviews. Design Transfer (Major Emphasis) Lead and govern Design Transfer activities from R&D to manufacturing sites. Ensure transfer packages are complete, compliant, and support reproducible manufacturing. Collaborate closely with Manufacturing Engineering and Operations to ensure clarity on specifications, tolerances, verification, and production requirements. Validate that design intent is preserved during industrialization. Ensure appropriate documentation is created and approved (DMR elements, specifications, test methods, inspection plans). Designing Quality into the Product (DfX) Lead the DfX program for the Design Center, ensuring application of: Design for Manufacturability (DfM), Design for Assembly (DfA), Design for Serviceability (DfS), Design for Reliability / Durability, Design for Safety, Design for Cost Ensure cross-functional DfX reviews are structured, documented, and effective. Drive preventive quality thinking across all NPD teams. Supplier Quality Management Lead Supplier Quality Management for both design and manufacturing phases. Oversee qualification, auditing, monitoring, and performance evaluation of suppliers critical to product design and lifecycle success including hand-over to manufacturing sites. Ensure supplier-related design inputs (components, materials, subassemblies) are clearly defined and controlled. Support investigations of supplier non-conformances, assess design impact, and drive corrective actions. Collaborate with global/purchasing SQM for strategic supplier alignment. NPD & Change Project Leadership (Project Management Emphasis) Ensure all New Product Development (NPD) and design change projects follow robust quality planning and design governance. Serve as Quality leader and steering member for project teams. Ensure project milestones include Quality reviews, risk updates, and verification/validation completeness. Approve phase gates, design changes, and technical deliverables from a quality standpoint. Support project managers with quality planning, risk mitigation, and compliance strategies. Support to Post-Market Performance (Field Quality) Provide technical Quality leadership to complaint handling and product investigations. Assess whether field issues indicate design gaps or require design enhancements. Support FAR/MDR technical evaluations (without owning vigilance process). Ensure post-market learnings are fed into design improvements, CAPAs, and risk files. Monitor field performance trends together with PMS and RA. Support to Manufacturing / Operations Though manufacturing is not performed at the Design Center: Provide expert technical Quality support to manufacturing sites for issues related to product design. Contribute to NC/CAPA investigations with potential design root causes. Ensure designs are manufacturable and adequately transferred to production. Support DMR content, specification clarity, and design related manufacturing requirements as needed. Support supplier investigations related to design inputs or design relevant components. Compliance, Audits & Continuous Improvement Lead preparation, hosting, and follow-up of audits and inspections (FDA, Notified Body, internal). Ensure timely and effective remediation of audit findings. Monitor and report Quality KPIs; identify trends and drive corrective actions. Implement systems to ensure ongoing state-of-control and inspection readiness. Identify and implement improvements to design processes, QMS robustness, and design reliability. Corrective & Preventive Actions (CAPA) Ownership Own and govern the full CAPA process for the Design Center, ensuring compliance with FDA QSR/QMSR, ISO 13485, ISO 14971, and corporate MedTech requirements. Ensure robust, data driven
The Director of Design Assurance & Site Quality is the senior quality leader for the Design Center and responsible for leading and developing the local Quality organization. This role leads the local Quality organization, owns and maintains the Design Center's QMS, and serves as the Site Quality Management Representative. As the owner of Design Quality, the Director ensures that all products developed at the site meet applicable regulatory, compliance, safety, and performance requirements throughout their lifecycle. The role provides leadership in Design Controls, Risk Management, DfX, Design Assurance, Design Transfer, Supplier Quality, Technical Documentation, and Audit/Inspection Readiness. The Director ensures design robustness, manufacturability, and continuous improvement, while also: Ensuring adequate technical support to Post Market Surveillance, field performance investigations, and manufacturing issues for all products designed at the center Ensuring Design Controls and Risk Management are implemented effectively and consistently Ensuring the site is continuously prepared for FDA inspections, Notified Body audits, and internal audits The Director ensures that product designs are safe, effective, manufacturable, and compliant throughout their lifecycle, and that quality culture and performance meet MedTech standards. This leader is a key member of the Design Center Management Team and the BU Quality Leadership Team, collaborating cross functionally with R&D, PMS, Regulatory Affairs, Manufacturing Sites, Supplier Quality, and Market Units across the MedTech business. Salary Range: $185,000-$205,000 Position is eligible to participate in a bonus plan with a target of 16% of the base salary (include only if applicable to the grade level) Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Hybrid role: Onsite Tues, Wed, Thurs Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future. Responsibilities include: Leadership & Organizational Management Appointed as Management Representative for the North Andover Design Center with responsibility and authority Lead the site Quality organization, including Design Assurance, Quality Systems, Compliance, and related functions. Quality Management System Ownership (Site QMS & QMR Role) Ensure processes required for the QMS are defined, documented, implemented, and maintained. Ensure awareness and understanding of applicable regulatory, customer and quality requirements across the site. Report regularly to top management on QMS performance, risks, and improvement needs. Maintain site certification(s) and compliance with ISO 13485, MDR, FDA QSR/QMSR, ISO 14971, and any other applicable standards. Lead site readiness and execution for FDA inspections, Notified Body audits, corporate audits, and internal audits. Oversee document control, training effectiveness, internal audit program, CAPA system, change control, and management reviews. Drive continuous improvement, implementing best practices and harmonization across MedTech where relevant. Design Assurance (Full Design Controls Ownership) Own and ensure effective implementation of Design Controls (FDA 820.30 / ISO 13485 7.3). Oversee: Design planning, inputs / outputs, and reviews. o Verification & Validation o Design transfer and Design changes Ensure products are designed for safety, efficacy, quality, manufacturability, usability, and compliance. Ensure comprehensive application of ISO 14971 Risk Management, including risk file maintenance and post market risk evaluation. Provide independent Quality approval for design deliverables and design changes. Ensure design documentation meets FDA 820.30, MDR Annex II/III, and global regulatory expectations. Ensure usability engineering (IEC 62366) and software lifecycle considerations (IEC 62304), where applicable, are integrated. Participate in and/or chair design governance bodies such as CCB, PRM, and design reviews. Design Transfer (Major Emphasis) Lead and govern Design Transfer activities from R&D to manufacturing sites. Ensure transfer packages are complete, compliant, and support reproducible manufacturing. Collaborate closely with Manufacturing Engineering and Operations to ensure clarity on specifications, tolerances, verification, and production requirements. Validate that design intent is preserved during industrialization. Ensure appropriate documentation is created and approved (DMR elements, specifications, test methods, inspection plans). Designing Quality into the Product (DfX) Lead the DfX program for the Design Center, ensuring application of: Design for Manufacturability (DfM), Design for Assembly (DfA), Design for Serviceability (DfS), Design for Reliability / Durability, Design for Safety, Design for Cost Ensure cross-functional DfX reviews are structured, documented, and effective. Drive preventive quality thinking across all NPD teams. Supplier Quality Management Lead Supplier Quality Management for both design and manufacturing phases. Oversee qualification, auditing, monitoring, and performance evaluation of suppliers critical to product design and lifecycle success including hand-over to manufacturing sites. Ensure supplier-related design inputs (components, materials, subassemblies) are clearly defined and controlled. Support investigations of supplier non-conformances, assess design impact, and drive corrective actions. Collaborate with global/purchasing SQM for strategic supplier alignment. NPD & Change Project Leadership (Project Management Emphasis) Ensure all New Product Development (NPD) and design change projects follow robust quality planning and design governance. Serve as Quality leader and steering member for project teams. Ensure project milestones include Quality reviews, risk updates, and verification/validation completeness. Approve phase gates, design changes, and technical deliverables from a quality standpoint. Support project managers with quality planning, risk mitigation, and compliance strategies. Support to Post-Market Performance (Field Quality) Provide technical Quality leadership to complaint handling and product investigations. Assess whether field issues indicate design gaps or require design enhancements. Support FAR/MDR technical evaluations (without owning vigilance process). Ensure post-market learnings are fed into design improvements, CAPAs, and risk files. Monitor field performance trends together with PMS and RA. Support to Manufacturing / Operations Though manufacturing is not performed at the Design Center: Provide expert technical Quality support to manufacturing sites for issues related to product design. Contribute to NC/CAPA investigations with potential design root causes. Ensure designs are manufacturable and adequately transferred to production. Support DMR content, specification clarity, and design related manufacturing requirements as needed. Support supplier investigations related to design inputs or design relevant components. Compliance, Audits & Continuous Improvement Lead preparation, hosting, and follow-up of audits and inspections (FDA, Notified Body, internal). Ensure timely and effective remediation of audit findings. Monitor and report Quality KPIs; identify trends and drive corrective actions. Implement systems to ensure ongoing state-of-control and inspection readiness. Identify and implement improvements to design processes, QMS robustness, and design reliability. Corrective & Preventive Actions (CAPA) Ownership Own and govern the full CAPA process for the Design Center, ensuring compliance with FDA QSR/QMSR, ISO 13485, ISO 14971, and corporate MedTech requirements. Ensure robust, data driven