Quality Systems Engineer: QMS, CAPA & Regulatory Readiness
Philips Iberica SAU
A leading health-technology company in Cambridge, MA, is seeking a Quality Systems Engineer to manage quality processes and ensure compliance with FDA regulations. The successful candidate will have over 5 years’ experience in quality operations within medical device manufacturing and will be responsible for risk assessments, QMS documentation, and cross-functional team leadership. Full-time onsite presence is required. Competitive compensation range is offered, alongside a comprehensive benefits package. #J-18808-Ljbffr Philips Iberica SAU
$102.48k - $163.97k
Quality Systems Engineer Job Description The Quality Systems Engineer... ...Management System (QMS), including analysis,... ...Document Control, Training, CAPA etc. ensuring that... ...and meets the regulatory requirements. Analyzes... ...inspections by ensuring readiness of documentation,...RegulatoryFull timeWork at officeImmediate startWork visaRelocation package3 days per week- ...Quality Engineer The Quality Engineer will support the Quality Information Systems Management (QISM) group by providing quality... ..., validation, regulatory, and quality requirements... ...ServiceNow, QMS, ERP, Veeva EDC, Compass... ...such as deviations, CAPAs, validation documents...Regulatory
- ...looking to hire multiple Quality Engineering positions in support... .../NCMRs, deviations, CAPA, root cause analysis,... ..., inspection readiness, and documentation activities... ...internal quality, regulatory, and customer requirements... ...readiness, quality systems, and manufacturing...Regulatory
- ...ISO 9001: FMEA: CAPA: ERP Systems: SMT or PCB: Lean... ...Position: Senior Quality Engineer (Manufacturing) - THIS IS... ...with strong experience in regulatory compliance, statistical methods... ...Quality Management System (QMS) to ensure consistent compliance...RegulatoryFull timeRelocation
- ...seeking a Senior Director, Quality Management Systems (QMS), reporting to the VP,... ...and sustained inspection readiness. As a key member of the Quality... ..., including deviations, CAPA, change control, document... ...tools remain aligned with regulatory requirements, industry expectations...RegulatoryLocal areaRemote work3 days per week
- ...Title: Devie - Senior Quality Engineer, Invitro Diagnostics Location... ...quality, safety, and regulatory compliance of IVD... ...a fit‑for‑purpose IVD QMS aligned with ISO 13485... ...processes. Provide system leadership across IVD... ...nonconformance, deviation, CAPA, complaint handling,...Regulatory
- ...implementation of Veeva Vault (CTMS, eTMF, and QMS). This role requires managing project... ...while ensuring compliance with regulatory requirements. The ideal candidate will have... ...stakeholders to ensure operational success and inspection readiness. #J-18808-Ljbffr Talent GroupsRegulatory
- Senior Manufacturing Quality Engineer Location : Cambridge, MA Department... ...manufacturing quality systems that help teams move from... ...processes within the QMS. Partner with Manufacturing... ...documentation is audit-ready and aligned with regulatory expectations. Establish...RegulatoryLocal areaFlexible hours
$195k - $275k
...The ideal candidate will have over 10 years in the biotech industry and a robust track record in TMF management, ensuring readiness for regulatory inspections. The role demands strong leadership, experience in strategic process improvements, and collaboration across Clinical...Regulatory- Getinge is searching for a Project Manager - Quality and Regulatory located in the United States, Massachusetts, Boston, to lead QMS enhancement initiatives. This role involves serving as the primary driver of projects execution across various QMS workstreams, coordinating...RegulatoryRemote job
- ...CAPA Quality Engineer We are looking for an experienced CAPA Quality Engineer to drive CAPA initiatives... ...ISO 13485 experience (medical device/regulatory environment). Technical/STEM... ...Detail-oriented with strong quality systems mindset. Qualifications: Must have...Regulatory
- ..., effective, and high-quality drugs, biologics, and... ...Real-time Inspection Readiness Develop, manage and contribute... ...Plans associated with regulatory filings and real-time... ...routine Quality System checks to support readiness... ...tools/methodology and CAPA #J-18808-Ljbffr...RegulatoryWork experience placement
- ...team and work in the design quality engineering across the entire product cycle... ...adherence to the quality systems and design assurance SOPs and... .... Provide quality and regulatory compliance guidance as needed... ...assurances, process controls, and CAPA systems designed to meet or...Regulatory
$110k - $130k
...ownership of all things Quality Highvisibility... ...Management System to AS9100 and ISO... ...flowdowns Own CAPA, root cause analysis... ...successful Senior Quality Engineer should have: ~... ...customers and regulatory audits Stable,... ...If you're ready to take the next step...RegulatoryLocal area- ...Job Description Senior Quality Engineer - Medical Device Industry - Boston We are seeking... ...play a key role in supporting quality systems, CAPA activities, supplier quality, and... ...functionally with Operations, Engineering, and Regulatory teams. Responsibilities...RegulatoryWork at office
- ...Quality Engineer Position Overview We are seeking a Quality Engineer... ...activities, and quality systems within a regulated environment... ...and Preventive Action (CAPA) activities. Participate... ...accordance with company and regulatory requirements. Qualifications...RegulatoryWork at office
- ...proactive and detail-oriented Quality Engineer to ensure that our product... ...development processes meet quality, regulatory and company standards. You... ...robust Quality Management System (QMS) to meet our business... ...corrective/preventive actions (CAPA) related to product design and...RegulatoryFull timeContract workLocal areaWork from homeFlexible hours
$130k - $180k
...overseeing and maintaining the local PV quality management system (QMS) to ensure compliance with... ...activities, supporting inspection readiness, CAPA management, compliance monitoring,... ...and Quality teams. While strategic regulatory engagement is led by PV leadership,...RegulatoryContract workTemporary workWork experience placementLocal areaShift work$85k - $100k
...Quality Assurance Engineer Department: Quality Employment Type: Full... ...application/execution of the QMS. This role... ...preventative actions (CAPA). What You'll Bring:... ...of Quality Management Systems. (QMS) Bachelor's degree... ...14971 and ISO 13485 regulatory requirements. Minitab...RegulatoryFull time- ...motivated Director of Quality Systems and GxP Compliance. Reporting... ...quality systems and regulatory compliance across... ...Quality Management System (QMS) transition from... ...operations to a commercial-ready, scalable, and... ...control, deviations, CAPAs, complaints, audits, document...Regulatory
$163.2k - $244.8k
...Manufacturing and Process Engineering organization. The... ...with global regulatory requirements, maintaining audit‑ready GMP facilities, and... ...‑use manufacturing systems. Accountable for effective... .../SCADA, Pi, ERP, QMS) and paperless... ...including investigations, CAPA, change control,...Regulatory- ...Design Quality Engineer The Design Quality Engineer will support the... ...engineering, manufacturing, regulatory affairs, marketing, R&D, and... ...leadership within the quality system, including corrective and preventive... ...are followed. Support CAPA, nonconforming material...Regulatory
- ConforMIS, Inc. is looking for a Product Quality Engineer II in Wilmington, MA. You will oversee quality assurance activities, drive process... ...across various teams to maintain compliance with regulatory standards. The ideal candidate should have a Bachelor’s degree...Regulatory
$75.2k - $103.4k
## Engineer, Quality EngineeringApplylocations: US, MA, Wilmingtontime... ...a motivated Quality Systems Engineer to join our... ...processes including CAPA, Internal Audits,... ...track mandatory quality, regulatory, and job-specific training... ..., and inspection-ready training records in compliance...RegulatoryPermanent employmentTemporary workFor contractorsInternshipWork at officeDay shift- Bicara Therapeutics is seeking a Vice President, Quality in Boston to lead the company's quality vision and strategy. This vital leader will ensure regulatory readiness, operational excellence, and the integrity of products, enabling the delivery of life-saving medicines...Regulatory
£45k - £57k per year
...United Kingdom Senior Product Quality Engineer Join a team where your... ...of reliability, safety, and regulatory compliance. This role offers... ...recommend mitigations Support CAPA activities where required... ...frameworks such as FDA Quality System Regulations, ISO 13485, EU...RegulatoryWorldwide- ...evolve Cytel’s global Quality Assurance strategy in... ...with business growth and regulatory expectations... ...the Quality Management System (QMS) Serve as a senior leader... ...variability in audit readiness, execution, and responses... ...signals Streamlining CAPA management through...Regulatory
$114.4k - $220.2k
...the-box thinking. The Staff Quality Engineer (QE) serves as a senior... ...and ensuring robust quality systems and control throughout the... ...Management System (QMS) to meet ISO, regulatory, and customer‑specific requirements... ...and preventive actions (CAPA) with measurable...Regulatory$252k - $269k
Clinical Quality Assurance Senior Leader provides... ...organization is ready for inspections, implements... ...risk-based quality systems, collaborates... ...to evolving regulatory expectations. Strategic... ...and ensure timely CAPA development and closure... ...to support the QMS and ensure delivery...RegulatoryLocal areaWorldwide$102.48k - $163.97k
...Job Title Software Design Quality Engineer Job Description The Software... ...ensuring their accuracy and regulatory compliance throughout the software... ..., Risk management, Systems validation, Traceability and... ...Understanding of all aspects of the QMS related to Software Design...RegulatoryFull timeWork at officeImmediate startWork visaRelocation package3 days per week
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