Global Quality Systems Lead — Design Controls & Risk
Boston Scientific
Boston Scientific is seeking a Principal Quality Systems Engineer to lead global Design Controls and Risk Management for combination products. You will shape procedures, drive governance, and advance enterprise quality initiatives across multiple sites. The role requires 7+ years in medical device Design Controls and Risk Management, with strong regulatory knowledge and collaboration across functions in a hybrid work model. #J-18808-Ljbffr Boston Scientific
$89.2k
...- Innovation - Caring - Global Collaboration - Winning Spirit... ...We are seeking a Senior Quality Systems Engineer - Global Design Controls to join the Global... ...Activities Process Owner, leading the governance, development... ...device Design Controls and Risk Management. ●...QualityRiskHourly payWork at officeLocal areaRelocationRelocation packageShift work3 days per week$89.2k
...the Role We are seeking a Senior Quality Systems Engineer - Global Design Controls to join the Global Quality Systems... ...Design Activities Process Owner, leading the governance, development, and continuous... ...device Design Controls and Risk Management. Demonstrated experience...QualityRiskWork at officeLocal areaRelocationRelocation package3 days per week$106.8k
...role: We are seeking a Principal Quality Systems Engineer - Global Risk Management & Design Activities (Combination Products... ...matter expert for Design Controls and Risk Management processes supporting... ...combination products. You will lead strategic initiatives that...QualityRiskHourly payWork at officeLocal areaRelocationRelocation packageShift work3 days per week$89.2k
...- Innovation - Caring - Global Collaboration - Winning Spirit... ...We are seeking a Senior Quality Systems Engineer – Global Design Controls to join the Global... ...Activities Process Owner, leading the governance, development... ...device Design Controls and Risk Management. ●...QualityRiskHourly payWork at officeLocal areaRelocationRelocation packageShift work3 days per week$110k - $160k
A leading diagnostics company in Massachusetts seeks a Senior Manager, Quality Systems to oversee global process design and compliance. The role involves developing global policies aligned with regulatory standards and driving process maturity. Candidates should have over...Quality$106.8k
...Innovation - Caring - Global Collaboration - Winning... ...are seeking a Principal Quality Systems Engineer – Global Risk Management & Design Activities to join the... ...matter expert for Design Controls and Risk Management... ...complex systems. You will lead strategic initiatives that...QualityRiskHourly payWork at officeLocal areaRelocationRelocation packageShift work3 days per week- Boston Scientific is seeking a Senior Quality Systems Engineer - Global Design Controls to lead governance of enterprise Design Activities, ensuring compliant product development and lifecycle management across sites. You will drive cross-functional collaboration, lead...Quality
- ...Senior Quality Systems Engineer Boston Scientific was recognized... ...to serve as a Global Risk Management Process Owner... ...role, you will lead the governance, development... ...you will partner with design teams, Global Risk Management... ..., including Design Controls, Production and...QualityRiskWork at officeLocal areaRelocation package3 days per week
- Candela Corporation is a leading global aesthetic device... ...partner closely with Quality, R&D, Engineering, Clinical... ...manage regulatory risk, navigate evolving... ...concept development, design controls, clinical evaluation,... ...Strong strategic and system-level thinking with a...QualityRiskWorldwide
- ...finishing. Our focus is to design, develop and produce high-quality, high-performance coatings... ...for a full time Quality Control Inspector who is responsible... ...during AS9100 Quality System Audits Assist Final Inspectors... ...how to perform Risk Analysis within all aspects...QualityRiskFull time
$98k - $138k
.... Financial Solutions Lead Full Time Professional... ...scalability of our financial systems. You will have... ...Partner with engineering to design, automate, and scale... ...prospective partners. Risk & Compliance Management... ...Cooperation / Teamwork Quality of Work Reliability Support...QualityRiskFull timeWork at officeImmediate startRemote work$130k - $140k
...identify and manage risk associated with... ...infrastructure design, construction,... ...testing systems to commercial,... ...academic labs, globally. Job Details We... ...highly skilled Controls Engineer to join... ...Geocomp! You will lead projects from concept... ...on‑time, high‑quality deliverables...QualityRiskWorldwide$110k - $140k
...to apply for the Design Quality Engineer role at Michael... ...0/yr The position leads design assurance... ...FDA, ISO, and global medical device regulations... ..., including risk management,... ...balloon‑based ablation systems that provide direct... ...documentation for design control processes....QualityRiskFull timeLocal area$150k - $190k
...Senior Manager, Supplier Quality is responsible for leading supplier Quality oversight for the Systems, Process Analytics, and... ...through collaboration with Global Quality contacts in... ...mechanisms to ensure sustained control of supplier performance, risk, and continuous...QualityRiskContract workFlexible hours$105k - $125k
...! Job Overview Staff Design Quality Engineer - a highly experienced... ...programs, high‑risk changes, and... ...matter expert for design controls, risk management, validation... ...design outputs. Lead quality evaluation of... ...management review by elevating systemic quality risks, adverse...QualityRiskFull timeWork experience placementFlexible hours- ...to national and global security. We value... ...components & systems, spanning air, land... ...capabilities, quality and dependability. # To design, manufacture & build... ...: Lead the evaluation,... ...and Production Control teams. Manage... ...standards. Conduct risk analyses, lead root...QualityRiskTemporary workWork at office
- ...developer and leading producer of fiber... ...to procurement controls, documentation... ...sourcing, and risk mitigation initiatives... ...with system build schedules... ...substitutions, and design changes to maintain... ...timelines Global Logistics & Material... ...execution RMA, Quality & Supplier...QualityRisk
$200k - $220k
...hiring a Sr. Director, Design and Supplier Quality Assurance to join... ...role provides global leadership for NPI design controls, design transfer,... ...Validation (TMV), Computer System/Software (non-... ...periodic/ad-hoc risk reviews.... ...Leadership & Culture Lead through company values...QualityRiskFull time$93.04k - $123.28k
...solutions used in controllers and peripherals of... ...development phases from design input through... ...coordination with overall system requirements.... ...correspondence when the quality, timeline, or budget are at risk. Sensitivity and... ...to meet stringent global regulatory requirements...QualityRiskTemporary workFor contractors$175k - $250k
...Description This role leads complex space... ...an optical sensor systems environment, overseeing... ..., schedule, cost, risk, and resource... ...maintaining program quality and meeting... ...IMS) to monitor and control cost, schedule, and... ...to ensure payload designs meet technical requirements...QualityRiskPermanent employmentFull timeContract workFor contractorsFor subcontractor$83 - $84 per hour
...opportunity to extend The Senior Systems Engineer will serve as a technical lead in the design and development of... ..., manufacturing, and quality engineers to deliver... ...hazards, failure modes, and risk mitigations. Partner... ...Part 820.30 (Design Controls). Demonstrated ability...QualityRiskContract work$82.1k
...we protect product quality, compliance and... ...product improvements, design changes, supply... ...file deliverables, risk documentation, and... ...applicable quality system and regulatory... ...quality systems, design controls, and regulatory... ...success working within global, cross‑functional...QualityRiskHourly payWork at officeLocal areaRelocation packageShift work3 days per week$90k - $110k
...as the U.S.-based quality and regulatory lead, ensuring full compliance... ...quality systems, supplier performance... ...imported product controls. It supports audits, design transfer, CAPA, inspections... ...‑end oversight of global manufacturing... ...Strong skills in risk management (ISO 14...QualityRiskLocal area- ...every day. We are the leading Innovator in women's health... ...Overview This Design Assurance Manager position... ...levels of customer quality. This role will support... ...quality assurance and control systems and activities. Responsible... ...in design control, risk management, quality...QualityRiskWork at officeImmediate startWorldwide
- ...improves product design or designs new... ...running design controls and designing... ...supporting product quality improvement for... ...problems Leading design visualization... ...and disposable systems that have... ...reliability using FMEA, risk management and... ...skills # Global project...QualityRiskWork experience placement
$115.8k - $202.7k
...consultant with the global resources of the world’s leading professional services... ...Insurance Broking, Risk Management or Employee... ...Participate in the design and buildout of MMA’... ...interface/design of systems as well as the... ...services Ensure quality of technology deliverables...QualityRiskMinimum wageLocal areaRemote workNight shift- ...experienced and motivated Hardware Lead to join our Air Traffic Systems (ATS) team. The successful... ...a critical role in the design, development, and... ...next generation Air Traffic Control (ATC) and Weather Data Reporting... ...Software, Systems, and Quality to deliver integrated...QualityRelocation package
$110k - $160k
Senior Manager, Quality Systems (Global Process Owner) Reporting to the head of Global Quality Systems... ...Manager‑GPO is responsible for the global design, standardization, governance, and... ...regulations and ensure proactive compliance. Lead change management efforts to drive...QualityTemporary workWork experience placementWork at officeLocal areaWork from homeFlexible hours$131.7k
...process expert for global inventory... ...accounting processes by designing, updating and... ...framework by leading change... ...stakeholders to manage risks, assumptions,... ...requirements, internal controls and their... ...proficiency. Quality Requirements... ...support Quality System compliance and...QualityRiskHourly payWork at officeLocal areaRelocationRelocation packageShift work3 days per week- A leading medical technology firm in Acton, MA, is seeking a Senior Systems Engineer to lead the design and development of innovative wearable medical devices. This role involves collaborating... ...and managing system definitions and risk assessments. The ideal candidate will...RiskHourly payContract work
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