Senior Design Quality Engineer - Medical Devices (FDA/ISO 13485)
Selby Jennings
EPM Scientific is partnering with a growing medical device company in Aliso Viejo, California, seeking a Senior Design Quality Engineer. This role is crucial in supporting product development from concept through to commercialization, ensuring compliance with FDA regulations and ISO standards. The ideal candidate will have a Bachelor's degree in Engineering, with over 3 years of relevant experience in Design Quality within the medical device field. Strong knowledge of design controls and risk management is essential for this high-impact role. #J-18808-Ljbffr EPM Scientific
- ...partnered with a growing medical device company in Orange... ...continuing to build out its Quality function and looking to bring in a Senior Design Quality Engineer. This is a high-impact... ...activities in compliance with FDA (21 CFR Part 820), QMSR, and ISO 13485 requirements Own and...Senior
- A global medical technology company is seeking a Senior Quality Engineer to join their Global Technical Service Quality team in Lake Forest, California. The role involves ensuring quality standards for products, collaborating with various teams on process efficiencies,...Senior
- Confluent Medical Technologies in Laguna Niguel, CA is seeking a Staff Quality Engineer to ensure compliance with quality standards and regulatory requirements in medical device development. The ideal candidate will have over 5 years of experience in quality roles within...Senior
- Terumo-Neuro-1 seeks a Lean Manufacturing Specialist to enhance efficiency and flow across productions. You will design operational systems, coach teams, and lead cross-functional projects to sustain a born-lean culture. Responsibilities include analyzing data, setting...Senior
- A medical device company is seeking an experienced engineer to support the design and manufacture of medical devices. This role involves creating 3-D designs, developing test... ...qualifications include familiarity with FDA regulations and advanced design techniques for...Senior
- ...Complaint Specialist for a growing medical device company in Aliso Viejo, California.... ...supporting CAPA initiatives and broader quality system functions. Ideal candidates... ...devices field, strong knowledge of FDA 21 CFR Part 820, and ISO 13485 compliance. Join a dynamic team...Senior
- ...Design Quality Engineer HonorVet Technologies (SDVOSB) provides specialized... ...pharmaceutical companies, medical device companies, biotech organizations... ...development experience. ISO 14971 understanding... ...product development in an ISO 13485 environment ~ Experience...Contract work
- ...Job Summary The Sr Quality Engineer will support product development and... ...build activities within a medical device environment. The role focuses... ...standards, and supporting design assurance, risk management,... ...concepts Understanding of ISO 13485 Experience developing, updating...Senior
- ...stakeholders to provide hands-on quality engineering support across the product... ...to key activities such as design controls, risk management,... ...experience in the medical device industry, including direct... ...product development in an ISO 13485 environment Experience with...
- ...and mentor a team of Quality Engineers, providing technical guidance... ...compliance with FDA Quality System Regulations... ...risk assessments, and design control deliverables.... ...FDA inspections, ISO audits, and regulatory... ...experience within the medical device industry. 2+ years of...Senior
- ...Senior Product Engineer Imagine being part of a team that's redefining... ...closely with Design Engineering, DFT Engineering... ..., Test Engineering, Quality and Reliability,... ...characterization of semiconductor devices, including TX, RX,... ..., marital status, medical condition, mental or...Senior
- Alcon seeks a Principal Software Engineer to maintain, enhance, and support software for on-market medical devices. You will drive changes from EOL updates, supplier hardware... ...collaborating with global teams to ensure quality and regulatory compliance. The role requires...Senior
- ...and existing manufacturing lines, and ensure compliance with quality standards. The ideal candidate will have at least six years of experience in the medical device industry, a bachelor's degree in engineering, and proficiency in statistical tools. Opportunities for...Senior
$110k - $135k
...Bionics, Inc. is a medical technology... .../Objective: The Senior Manufacturing Test Engineer leads the development... ...ensures product quality and reliability by designing robust test... ...regulatory standards (FDA, ISO 13485, GMP) Mentor... ...integration Medical device or highly...SeniorWork at officeLocal area$105.07k - $131.33k
Terumo Group in Aliso Viejo, California, is seeking a Senior Engineer in Quality Engineering. This role focuses on supporting the transfer and manufacture of medical devices across global sites while collaborating with R&D, NPI, and Manufacturing teams to ensure robust...Senior- indie Semiconductor is seeking a Senior Product Engineer to drive radar transceiver, digital SoC, and power ASIC products through development... ...and datasheet specifications. Collaboration spans Design, DFT, Test, Quality, Applications, Marketing, and offshore partners to...Senior
$115k - $145k
...Senior Manufacturing Automation Engineer The Senior Manufacturing Automation... ...in a regulated medical device production environment... ...improve safety, quality, throughput, cost,... ...and process design reviews with internal... ...comply with GMP, FDA, and ISO 13485 and internal quality...SeniorWork at officeLocal area- Terumo-Neuro-1 is seeking an engineering professional to support and lead teams in developing medical device products, including writing specifications, maintaining product processes, designing fixtures, and testing processes, equipment, and materials to ensure concepts...Senior
- ...Confluent Medical Technologies is dedicated... ...‑class medical devices through innovative... ...material science, engineering and manufacturing... ...for a Staff Quality Engineer to join... ...management, quality and design control... ...experience with FDA, ISO 13485 and EU MDR Design...Work at officeLocal areaVisa sponsorshipWork visa
- indie.inc in Aliso Viejo, California, is seeking a Senior Staff / Principal Product Engineer to oversee product engineering for cutting-edge semiconductor products. You will develop test plans and analyze product performance, driving improvements through cross-functional...Senior
- ...Software Quality Engineer Relevant Experience(in... ...to solve product design and process technical... ...knowledge of FDA Guidance on the General... ...environment (Medical Device, Aerospace, etc.)... ...including: ISO 13485, 21 CFR Part 820... ...Product Software Senior Quality Engineer...
$105.5k - $168.8k
...of the largest global medical technology companies... ...passion of all of us—from design and engineering to the manufacturing... ...As a Sr. Software Quality Engineer at Becton,... ...reliability of our medical device software. You will be... ...requirements (e.g., FDA, ISO 13485, IEC 62304)....SeniorHourly payShift work$99k - $145k
...and Digital Infrastructure Division is currently seeking a Senior Quality Engineer in Santa Ana, CA. The Senior Quality Engineer is responsible... ...activities and regular audits including Eaton QMS implementation, ISO 9001 audits and related activities, and employee engagement...SeniorWork at officeLocal areaRelocation package$114.4k - $171.6k
A leading eye care company is seeking a Principal Engineer to support Software Life Cycle Management for its Medical Devices. This role focuses on developing software for medical devices, coding updates, and collaborating closely with various teams to ensure software integrity...$109.14k - $140.01k
EssilorLuxottica in Lake Forest, CA is looking for a Sr. Engineer - Quality to support manufacturing processes such as Lens Molding and Frame Molding. This role involves driving quality improvement, analyzing data to detect opportunities, and leading corrective actions...Senior- ...product development processes and design control is preferred Strong... ...fundamentals and experimental engineering techniques Knowledge of ISO 13485, Medical Device Regulatory Standards, MDD and... ...functional teams Presentation to Senior Management Excellent...Senior
- EssilorLuxottica, including Oakley, is seeking a Senior APQP Quality Engineer to support New Product Development by preventing failures through data... .... The role emphasizes guiding program teams, performing design and process risk analyses, and delivering robust quality...Senior
$109.14k - $140.01k
...Rewards: Benefits/Incentive Information GENERAL FUNCTION The Sr. Engineer - Quality supports the required processes (i.e. Lens Molding, Frame... .... Master's Degree. Lean Tools. Quality Systems (ISO 9001). Project Management. Pay Range: $109,135.00 - $140,01...SeniorMinimum wageFull timeLocal areaImmediate start$65 - $85 per hour
...Overview Medical Device Leader! Principal Quality Engineer Opportunity! This Jobot Consulting job is hosted by:... ...Device industry, with a focus on FDA regulations, ISO 13485, CAPA, and other regulatory... ...Lead the review and approval of design and process changes, ensuring compliance...Hourly payContract work$75k - $95k
...Applied Medical is a new generation medical device company with a proven business model... ...delivering the highest quality products, enables team... ...Description The Design Engineer II contributes to Applied... ...Drug Administration (FDA) regulations and ISO quality systems....Work experience placementLocal area
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