Senior Design Quality Engineer, Medical Devices (QMS)
Regulatory Jobs
Philips in Bedford, MA is seeking a Senior Design Quality Engineer to lead the design control process for medical devices, overseeing inputs, verification, validation, and design transfer. You will drive process validation, CAPA, risk management, and PMS analytics to ensure regulatory and quality standards are met throughout the product lifecycle. The role requires 5+ years in FDA-regulated environments, strong knowledge of ISO 14971, and a Bachelor’s in quality/engineering. #J-18808-Ljbffr Regulatory Jobs
$102.48k - $163.97k
...Job Title Senior Design Quality Engineer Job Description The Senior Design Quality Engineer is... ...development, implementation, and revision of QMS processes, including standard... ...years’ experience in FDA regulated medical device environments, with a focus on Design...SeniorWork at officeImmediate startWork visaRelocation package3 days per week$140k - $185k
A leading staffing firm is seeking a Quality Engineer to lead product lifecycle quality initiatives in Bedford, Massachusetts. This role requires a bachelor's degree in engineering, 9+ years in medical devices, a strong understanding of regulatory standards, and proficiency...Senior- Philips is seeking a Senior Supplier Quality Engineer to join the Image Guided Therapy Devices (IGTD) Quality team in Bedford, MA. The role drives supplier performance, APQP and process validation while ensuring regulatory compliance across the product lifecycle. You will...Senior
- Intepros is seeking a Sr. Supplier Quality Engineer to lead supplier quality activities, qualification of components and devices, and ongoing continuous improvement in a medical device manufacturing environment. The role partners with engineering and operations to ensure...Senior
- Philips is seeking a Senior Quality Systems Engineer in Bedford, MA to maintain a compliant QMS and drive continuous improvement. Responsibilities include managing audits, document control, training, CAPA, and SOP development, with strong focus on risk assessment and cross...SeniorWork at office
$102.48k - $163.97k
Job Title Senior Design Quality Engineer Job Description The Senior Design Quality Engineer is responsible... ..., implementation, and revision of QMS processes, including standard... ...years’ experience in FDA regulated medical device environments, with a focus on Design...SeniorWork at officeImmediate startWork visaRelocation package3 days per week$90k - $180k
...products in diagnostics, medical devices, nutritionals and branded... ...160 countries. Job Title Senior Electrical Engineer, Medical Devices Working at... ...mortality rates, and improve quality of life for our heart... ...of CardioMEMS electronic designs Draft test protocols and reports...SeniorFor contractorsRemote workWorldwide- BioTalent is seeking a Senior Quality Engineer to strengthen quality systems across CAPA, supplier quality, complaints... ...of regulated quality engineering experience in medical devices, working with CAPA, audits, and Design Controls within FDA/ISO 13485 environments. #J...Senior
- Anika Therapeutics is seeking a Senior Process Engineer to lead process development and equipment implementation in our Bedford, MA facility... ...needs and focuses on safe, compliant manufacturing of medical devices and drug products. You will drive process improvements, validate...Senior
$110k - $140k
Werfen in Bedford, MA seeks a Senior Systems Engineer to lead system integration, verification, and validation across hardware and software. You... .... The role offers $110,000 to $140,000 base salary with medical, dental, vision coverage, a 401(k) with employer match, and...Senior- ...seeking a Laboratory Automation Systems Engineer to generate and manage testable system requirements... ...teams, mentor others, and contribute to design control activities. The role requires experience in laboratory automation for medical devices, Linux-based environments, and strong...Senior
- Instylla, Inc. in Bedford, MA, seeks a Senior Advanced Manufacturing Engineer to drive NPD manufacturing... ...validation, partnering with R&D, Production, Quality, Regulatory, and Supply Chain to... ...for transfer to Operations. You will design for manufacturability, engage external...Senior
$102.48k - $163.97k
...Job Title Senior Quality Systems Engineer Job Description The Senior Quality Systems Engineer is... ...compliant Quality Management System (QMS), including analysis, development and... ...years’ experience in FDA/ISO 13485 medical device quality operations/manufacturing environments...SeniorFull timeWork at officeImmediate startWork visaRelocation package3 days per week- Werfen seeks a Senior Mechanical Engineer II to lead the design, development, and integration of complex electromechanical systems for medical diagnostics and IVD products. You will translate requirements into system architecture, optimize performance, manufacturability...Senior
- Werfen is seeking a Senior Systems Engineer to lead system-level verification and validation activities across hardware and software interfaces... ...or Science with 8+ years in product development and experience in medical device environments. #J-18808-Ljbffr UNAVAILABLESenior
$150k - $180k
...dedication to innovation and quality. We’re passionate... ...in the areas of design, development, production... ...maintain compliance of the QMS Interprets... ...degree or equivalent in engineering or science Experience... ...years of experience in medical devices, pharmaceuticals, diagnostic...SeniorWorldwideShift work- Role: Senior Mechanical Engineer Heart Failure R&D Location: Burlington... ...Support (MCS) devices , including Left Ventricular... ...to contribute to the design, development, testing... ...sustaining Class III medical devices. The ideal... ...with regulatory and quality requirements. Develop...SeniorContract work
- ...seeking a Laboratory Automation Systems Engineer in Bedford, MA to generate and manage... ...experience in Laboratory Automation for medical devices, leading verification projects, and Linux... ...to mentor others and contribute to design-control documentation. #J-18808-Ljbffr...Senior
$130k - $160k
Werfen is seeking a Senior Mechanical Engineer II in Bedford, MA to lead the design and integration of complex electromechanical systems for diagnostic products.... ...of $130,000 to $160,000 with benefits including medical, dental, vision, 401(k) with employer match, and...Senior- GLAUKOS - SR. SUPPLIER QUALITY ENGINEER II Location: Burlington, MA How will you make an impact... ..., and distribution of innovative medical devices and pharmaceutical products. You will... ...delivery. Support Quality Management System (QMS) improvements and organizational...Senior
$120k - $140k
...opportunity to join a growing medical device company at a key... ...its evolution, with quality playing a meaningful... ...to work upstream in design , influence technical... ...start. If you’re a Senior Quality Engineer who enjoys partnering... ...Quality Management System (QMS) Ensure compliance...SeniorFull time$102.48k - $163.97k
Job Title Senior Quality Systems Engineer Job Description The Senior Quality Systems Engineer is responsible... ...Quality Management System (QMS), including analysis, development and... ...years’ experience in FDA/ISO 13485 medical device quality operations/manufacturing environments...SeniorFull timeWork at officeImmediate startWork visaRelocation package3 days per week- ...EPM Scientific is seeking an experienced Senior R&D Engineer to drive development and commercialization of innovative medical device products. The role focuses on leading projects from concept through design transfer in a regulated setting, collaborating with cross-functional...Senior
- Katalyst CRO in Cambridge, MA seeks a Regulatory/Quality Systems Engineer to ensure design controls, risk management, and V&V alignment across the product lifecycle for medical devices. Candidates should have strong systems thinking, experience with ISO 13485 and ISO 14...
- Amgen Massachusetts is seeking a Sr. Engineer in Device Engineering to support device development and robustness across Design for Robustness disciplines (Kinematic, Tolerance,... ...problem solving, collaborate with manufacturing, quality and suppliers, and help ensure designs meet...Senior
- Prostaffworkforce is seeking a Senior Device Engineer in Billerica, MA to provide mechanical and electromechanical... ...support for sustaining existing medical products and new projects in a... ...onsite role covers investigations, design controls, risk analysis, testing, documentation...SeniorFull timeContract work
- ...States is seeking a Mechanical and Electromechanical Engineer to provide sustaining engineering for existing medical products and contribute to new projects. You will support product investigations, develop design control documents, perform tests, and help ensure compliance...Senior
- MKS Instruments, Inc. is seeking a Principal Product Compliance Engineer to lead regulatory testing and ensure compliance across Plasma and Reactive Gas product lines. You will collaborate with engineering teams and external facilities to meet requirements and enable successful...Senior
- Werfen is seeking a Senior Systems Engineer to translate user needs into system-level verification and validation test cases, executing tests across hardware, software and subsystems. You will support risk management activities, analyze results, and collaborate with cross...Senior
- What You’ll DoThe Senior Quality Engineer is responsible for supporting the effective establishment... ...development with Quality expertise in design control, risk management, and human factors/usability engineering of medical devices, as well as driving continuous improvement...SeniorFull timeWork at officeImmediate start
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