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$133.5k - $192.83k
## Device - Senior Quality Engineer, Invitro... ...quality, safety, and regulatory compliance of IVD... ...understanding of the immune system and innovative... ...fit-for-purpose IVD QMS aligned with ISO 1... ...inspection readiness within the device... ...nonconformance, deviation, CAPA, complaint...RegulatoryWorldwide- Job Summary: The Quality Engineer will support the Quality Information Systems Management (QISM) group by providing... ...integrity, validation, regulatory, and quality... ...including ServiceNow, QMS, ERP, Veeva EDC, Compass... ...events such as deviations, CAPAs, validation documents,...Regulatory
- ...Real-time Inspection Readiness. Develop, manage and contribute... ...Plans associated with regulatory filings and real-time inspection... ...intelligence. Perform routine Quality System checks to support readiness.... ...tools/methodology and CAPA. Other Activities:...RegulatoryWork experience placement
- ...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
- ...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
$85k - $105k
Quality Assurance Specialist II, Device Engineering Terrestrial (formerly known as Vaxess... ...validation readiness, and batch record/... ...safety, efficacy, and regulatory requirements. ● Administer... ...Management System (QMS) in accordance with... ...the QMS, including CAPA, deviation...RegulatoryWork at office$43.92 - $68.62 per hour
...Overview As a Senior Design Quality Engineer (DQE) for our medical... ...and integration with system‑level risk management... ..., and audit readiness Supporting verification... ...Leading or supporting CAPA, nonconformance investigations... ..., and contributing to regulatory submissions (e.g., IDE...RegulatoryHourly payContract workRemote work- ...machines and fabricates complex jet engine parts, components and assemblies for... ...Position Description: The Director of Quality Management Systems (QMS) and Compliance is responsible for... ...customer-specific requirements, and regulatory standards across the organization....RegulatoryFull time
- ...Responsibilities Support global Quality Management System (QMS) transition from clinical-... ...operations to a commercial-ready, scalable, and inspection-... ...control, deviations, CAPAs, complaints, audits, document... ...and supports global regulatory expectations. Strengthen...Regulatory
- ...Head Of Quality & Regulatory Compliance (QRC) AG Mednet is a... ...CFR Part 11, Computer System Validation, ICH GCP, HIPAA... ...Management System (QMS) and regulatory compliance... ..., and release readiness and approval. Develop... ...requirements. Manage the CAPA / Quality Event...RegulatoryWork at officeWorldwide
- ...Compliance Specialist Validation Support. This role assists with audit readiness, validation documentation, and compliance improvement... ...collaborating with validation teams during audits, leading deviation and CAPA processes, and tracking validation metrics. Candidates should...
- ...applicable global regulatory requirements, industry... ...Affairs, Quality Assurance, and external... ...support inspection readiness, quality oversight... ...across the PV system. Position Responsibilities... ...System (QMS), including SOPs,... ...metrics, deviations, CAPAs, reconciliations,...RegulatoryLocal area
$90k - $120k
...Quality Assurance Engineer Department: Quality Employment Type... ...application/execution of the QMS. This role... ...preventative actions (CAPA). What You'll Bring... ...of Quality Management Systems. (QMS) ~ Bachelor's... ...14971 and ISO 13485 regulatory requirements. Minitab...RegulatoryFull time$98.1k - $123.86k
...Medical Device QMS Auditor We exist to create... ...Medical Devices (or Regulatory Services) team... ...Analyze and assess quality management systems with emphasis on design... ...Bachelor's, or higher) in Engineering, Science, or a related... ..., supplier controls, CAPA, nonconforming product...RegulatoryTemporary workFlexible hoursNight shift- ...the operating system for scientific... ...platform meet the regulatory expectations of... ...and biotech Quality and Validation... ...with Product, Engineering, Security, and... ...including pre-audit readiness, evidence preparation... ..., Veeva Vault QMS, or equivalent)... ...records, and CAPA. BS in...RegulatoryImmediate startFlexible 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$83.5k - $149.5k
...collaborative Senior Quality Engineer to join our Product Quality... ...device efficacy, and regulatory-aligned quality... ...preventive actions (CAPAs) — especially for contact... ...manufacturing readiness by identifying device... ...preferred. Tools & Systems Proficient in Microsoft...RegulatoryTemporary workWork at officeLocal areaFlexible hours$275k - $315k
...level leadership of GMP Quality and Quality across GxP... ...Quality Management System (QMS). Lead a team of subject... ...strategy and regulatory expectations. Present... ...including: Deviations, CAPA, Change Control Document... ...Ensure inspection readiness at all times, including...RegulatoryContract work$94k - $150k
...Global Supplier Quality (GSQ) QMS Leader (Global) We are... ...shared Quality Management System (QMS) for Supplier... ...compliant, and future-ready solutions that... ...consistent adoption, regulatory compliance, and sustained... ...stakeholders across Quality, Engineering, Procurement,...RegulatoryFull timeWork at officeLocal areaWork visaRelocation package3 days per week$140k - $160k
...responsible for conducting independent quality control (QC) assessments to... ...and preventive actions (CAPA), as needed. Track QC... ...trend analysis. Inspection Readiness Support Support inspection... ...learned from QC activities and regulatory inspections into training,...RegulatoryWork at officeRemote workWorldwideRelocation package$127k - $190.4k
...Manager, GMP Inspection Readiness The Senior Manager, GMP... ...mitigating risks, and supporting regulatory inspections from the... ...matter expert in GMP quality, compliance, and quality systems, the Senior Manager will... ...related support (draft review, CAPA tracking, etc.)....RegulatoryContract workWork experience placementSummer workRemote workFlexible hours2 days per week$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$181k - $286.96k
Director of Quality, Internal Audit and Compliance Engineering The Director of Quality... ...with regulatory requirements (FDA... ...robust quality systems, risk-based methodologies... ...inspection readiness, systemic issue... ...by integrating CAPA, root cause... ...risks across the QMS Ensures robust...RegulatoryFull timeWork at officeWork visaRelocation package3 days per week$127k - $190.4k
Vertex Pharmaceuticals is seeking a Senior Manager, GMP Inspection Readiness in Boston, MA. This role involves leading GMP inspection... ...developing inspection readiness plans, and ensuring compliance with regulatory standards. The ideal candidate has a Master’s degree and...Regulatory- ...Clinical Quality Manager – Clinical Trial Audits We are looking... ...Drive inspection readiness and support regulatory audits (e.g., FDA, notified... ...deviations, nonconformances, and CAPA Perform quality review of... ...teams Strengthen QMS, SOPs, and audit frameworks...Regulatory
$93.5k - $116.5k
...from cyberattack. The Software Quality Engineer is an experienced and... ...supporting the FMI quality system are compliant with the cybersecurity... ..., Data Privacy and Regulatory Affairs, ensuring "security... ...Quality Management System (QMS). The role will lead...RegulatoryImmediate start$181k - $286.96k
...Cambridge, MA is seeking a Director of Quality for Internal Audit and Compliance Engineering. This leadership role is... ...program and ensuring compliance with regulatory requirements. Candidates should... ...experience with FDA regulations and CAPA. The position includes working in...Regulatory3 days per week- ...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
$142.4k - $224.1k
...consistent, accurate, high‑quality data from clinical... ...inspection readiness as well as... ...and following up on regulatory inspections. Operational... ...management system are in place for studies... ..., responses and CAPAs. Acts as the subject... ...Council regarding QMS, RACT, quality...RegulatoryFor contractorsWorldwide
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