Quality Engineer: Medical Devices, CAPA & Compliance
Prospect Life Sciences
Prospect Life Sciences in Denver seeks a Quality Engineer to oversee product and process quality within FDA-regulated environments. You will manage CAPA, nonconforming materials, investigations, and inspections across the QMS. You will collaborate with Manufacturing, Development, Supply Chain, and QA teams to ensure regulatory compliance, process controls, and ongoing improvement initiatives. A BS in engineering or life sciences and 5+ years' experience are preferred. #J-18808-Ljbffr Prospect Life Sciences
$85k - $95k
LivaNova is seeking a Quality Engineer in Arvada, Colorado, to ensure compliance with its quality management system for medical devices. This role involves evaluating non-conforming products, leading CAPA projects, and improving product quality. The ideal candidate should...Suggested- Katalyst CRO is seeking a Design Quality Engineer (DQE) in Denver, Colorado. The DQE will ensure product compliance with regulatory standards and quality requirements. This role collaborates closely with R&D and manufacturing to embed quality in product design. Candidates...Suggested
$60k - $75k
...Veterans Interactive seeks a CAPA Specialist in Englewood,... ...the CAPA lifecycle and ensure compliance with QMS and regulatory standards... ...with teams for quality improvement. The ideal candidate... ...years of experience in the medical device sector, along with expertise...Suggested- Highridge Medical in Westminster, Colorado, is seeking a highly skilled Quality Management System Specialist. This... ...encompasses ensuring QMS compliance with global regulatory... ...and driving CAPA activities. The specialist... ...particularly in the medical device or pharmaceutical...Suggested
- ...The Sr. Quality Engineer is responsible for ensuring the quality and compliance of our products and processes in accordance with... ...and FDA regulations within the medical device manufacturing process for our... ...corrective and preventive actions (CAPAs) to address quality issues...SuggestedPermanent employmentTemporary work
- ...Solutions Inc in Englewood, CO is seeking a Quality Engineer for a 12-month contract. The candidate will manage CAPA processes, ensure compliance with global quality standards, and... ...in regulated industries such as medical devices. Strong technical writing and analytical...Contract work
- Akkodis is seeking a Quality Engineer on a contract basis with a client in the Medical Device sector. Highly preferred: experience in FDA/ISO regulated manufacturing environments. Responsibilities include inspection planning, GD&T review, MSA/Gage R&R studies, and measurement...Contract work
- ...We offer Comprehensive medical, dental, and vision... ...Job Summary The Sr. Quality Engineer is responsible for ensuring the integrity, compliance, and continuous improvement... ...audits. Audits, CAPA, and Risk Management... ...Experience in medical device, ophthalmic, or contact...Temporary workWork at officeLocal areaMonday to Friday
- Zimmer Biomet is seeking a CAPA Specialist in Englewood, Colorado to lead the CAPA lifecycle and contribute to audit excellence.... ...experience managing Corrective and Preventive Actions in the medical device field, with a strong focus on problem-solving and collaboration...
- Senior Test Automation Engineer - Cybersecurity MSSP (Colorado) We are representing a Colorado-based cybersecurity Managed Security Service... ...a fast‑moving organization delivering advanced security and compliance solutions to small and mid‑sized businesses. Role Overview...Full timeWork at office
$120k - $180k
Klaviyo is looking for a highly motivated Senior Security Compliance Engineer to enhance compliance operations and integrate GRC tooling. This role focuses on automating compliance workflows, partnering with cross-functional teams, and ensuring continuous control monitoring...$88k - $110k
...Warehouse Operations Engineer – Aurora, CO Be a part... ...risks reduction. Quality Ensure that the... .... Ensure proper CAPA follow up and reporting... ...Ensure traceability and compliance processes are adhered... ...enroll in our company medical, dental and vision plans...Temporary workLocal areaFlexible hours$85k - $95k
...Suitability/Public Trust Fully remote Software Engineering Services Overview GovCIO is currently hiring for Mid Level Quality Assurance Engineer to test and automate... ...~ AWS Cloud ~ Performance Testing ~508 Compliance ~ Azure ~ Agile Environments...Full timeCurrently hiringRemote workFlexible hours$90.9k - $131.8k
...are currently seeking a Senior Automation Engineer to join our growing Energy and Resources... ...for understanding and working in compliance with all health and safety rules and regulations... ...least 20 hours per week) have access to medical, dental, and vision plans, a wellness...Full timeTemporary workPart timeFor contractorsFor subcontractorCasual workWork at officeLocal areaRemote workFlexible hours$112.95k - $169.42k
...Knowledge of accessibility testing (WCAG compliance, axe-core) Experience with visual... ...SpecFlow) Experience mentoring junior test engineers Familiarity with cloud test platforms (... ...offerings include but are not limited to, medical, dental, and vision insurance, life and...Contract workLocal area- ...THE ROLE The Regional Quality Control Director (RQCD... ...process control, regulatory compliance, and continual... ...and preventive actions (CAPAs), and data-driven analysis... ...Bachelor’s degree in Engineering, Construction... ...Roth after-tax savings Medical, Dental, Disability and...Work experience placementLocal areaRemote workFlexible hours
$123.75k - $157.23k
.... That's what this role exists to build. Not a traditional quality engineering role At most companies, a quality engineer inherits a system... ...to earn credibility on the floor rather than enforce compliance from a desk. You probably have Experience as a quality engineer...Permanent employmentFlexible hours$130k - $160k
...mission forward. As a global medical technology leader for... ..., Virginia Site Quality leader and Management Representative... ...function a medical device design and... ...integrity and regulatory compliance. Partner with R&D, supply... ...into deviations, CAPA (Corrective and Preventive...Hourly payWork experience placementFlexible hours$60k - $75k
...are looking for a sharp, proactive CAPA Specialist to join our elite Quality Department in Englewood, Colorado... ...Paragon 28's QMS to ensure peak compliance and operational excellence.... ...Preventive Actions (CAPA) within the medical device industry. A strong background in...- Redbock - an NES Fircroft company is seeking a Sr. Manufacturing Engineer for a 24-month contract based in Lafayette, CO. The role will... ...engineer during the implementation of design changes for a medical device. Ideal candidates must have a Bachelor's degree in a...Contract work
- ...An aerospace technology company is seeking a Senior Software Quality Engineer II to ensure the quality, reliability, and compliance of mission‑critical software systems. What you’ll do: Lead software testing, validation, and quality assurance activities. Develop and maintain...
- ...Description: We are seeking a skilled Medical Device Manufacturing Engineer to support manufacturing validation, inspection methods, and quality documentation activities within a... ...strong knowledge of inspection tools, ISO compliance, and medical device regulatory...
- ...aerospace communications company is seeking a Senior Supplier Quality Engineer to support the quality and reliability of advanced satellite... ...with suppliers and internal engineering teams to ensure compliance with aerospace standards, drive continuous improvement initiatives...
- PuroAir is looking for a hands-on Quality Engineer to aid in our manufacturing operations. This long-term contract position requires strong problem-solving skills and mechanical aptitude. Responsibilities include supporting Quality Management Systems, leading root cause...Long term contract
- Sr. Manufacturing Engineer - Medical Devices Sr. Manufacturing Engineer - Medical Devices 1 day ago Be... ...product release ensuring appropriate Quality Management System procedures and... ...Ensures processes and procedures are in compliance with regulations. Requirements: 4+ years...Contract workLocal areaRelocation
- ..., and migrate legacy CAPA records into EtQ to ensure... ..., accuracy, and compliance with global procedures... ...and internal quality system requirements.... ...Regulatory, Operations, and Engineering to support CAPA execution... ...control systems. Medical device or other regulated industry...Work at office
- ...Board Member, Medical Devices About the Company Respected medical device & diagnostics organization Industry Medical... ...strategic decision-making, and ensuring the financial integrity and compliance of the organization. Applicants for the Board Member...
- ...Richmond Safety Services is looking for a driven and detail-oriented Quality Control Manager to join our growing team across multiple... ...initiatives and ensure the highest standards of safety and compliance in everything we do. If you're passionate about building a culture...
$49.78 - $74.05 per hour
Job Summary and Responsibilities The CE Medical Device Network Engineer II will use the latest technology and testing analysis activities to ensure... ...or equivalent experience. Experience with HIPAA/HITECH compliance standards. Valid Drivers License. Preferred:...Night shift$103k - $163.97k
...Title Operations Quality Manager Job Description... ...goals and compliance with all regulatory... ...Image Guided Therapy Devices (IGTD). Your role:... ...responses and leads CAPA activity-CAPA... ...in FDA regulated medical device environments... ...degree in Quality, Engineering or a related Scientific...Full timeWork at officeWork visaRelocation package3 days per week
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