CAPA & Quality Systems Engineer
Regulatory Jobs
Inspire Medical Systems is seeking a CAPA/Quality professional to lead corrective and preventive actions across internal and supplier processes. You will work with Development, Manufacturing, Marketing and IS to ensure CAPA activities align with Inspire procedures and regulatory requirements. The role requires 2–5 years in medical device quality/design, strong leadership, and proficiency with standard MS Office tools. #J-18808-Ljbffr
- Recruiter: Spencer Gregory HaleQuality Systems Engineer IIAbout the role:As a Quality Systems Engineer II, you will support the Corrective and Preventative Action (CAPA) process at Maple Grove, inclusive of nonconforming events. The Quality Systems Engineer II will support...SuggestedHourly payWork at officeLocal areaRelocationRelocation packageShift work3 days per week
$70k - $90k
...ABOUT INSPIRE MEDICAL SYSTEMS Inspire is the first of its kind medical... ...process improvements, quality system requirements and process... ...corrective and preventive action (CAPA) process for both internal... ...Bachelor's degree in an engineering discipline such as electrical...SuggestedWork experience placementLocal areaFlexible hours$75k - $112.6k
...stamping and device assembly. Learn more at Position Summary The Quality Systems Engineer will be responsible for providing core quality business... ...processes to include Engineering/Document Change Orders, CAPA, Management Review, Standards Library, Internal Audit, New Customer...SuggestedHourly payContract workTemporary workWork at officeLocal area$71.5k
...Recruiter: Spencer Gregory Hale Quality Systems Engineer II About the role: As a Quality Systems Engineer II, you will support the Corrective and Preventative Action (CAPA) process at Maple Grove, inclusive of nonconforming events. The Quality...SuggestedHourly payWork at officeLocal areaRelocationRelocation packageShift work3 days per week- ...We're Hiring: Senior Supplier Quality Engineer Location: Minneapolis, MN 55432 (Onsite) Job Description... ...development, APQP, PPAP, and quality system processes. Key Responsibilities: Manage... ...corrective and preventive actions (CAPA). Lead supplier corrective action requests...Suggested
- ...stage medtech company advancing the Edison System, a novel non-invasive sonic beam therapy... ...Why This Role Matters) The Sr. Supplier Quality Engineer will lead the product assurance... ...external audit activities as needed Lead CAPA investigations, action planning, and follow...Full timeTemporary work
- ...Medical’s first product, the Evoke® System, is designed to deliver known,... ...lives. Reporting to the Director of Quality, the Sr. Supplier Quality Engineer is responsible for ensuring external... ...Corrective Action Requests (SCARs), and CAPAs, ensuring effective root cause...Contract work
$82.7k - $110.3k
...Senior Supplier Quality EngineerSleep Number® is the leader in personalized... ...Senior Supplier Quality Engineer (Sr. SQE) to lead supplier... ...Experience with QMS, APQP, PPAP, CAPA/SCAR, auditing, and supplier development... ...and regulatory quality systems.Experience with statistical...Work at officeNight shift- ...a career. Job Purpose:The AQE Engineer will lead the deployment and execution of Advanced Product Quality Planning (APQP) processes across... ...teams to identify key system & subsystem risks and mitigate... ...process), Control Plans, PPAP, CAPA, and Six SigmaQuality Engineer...Full timeSummer workCasual workWork visaFlexible hoursWeekend work1 day per week
$115k - $150k
...Join to apply for the Senior Quality Engineer role at Real We're hiring a Senior Quality Engineer for a leading medical device company in Minneapolis... ...Highlights Ensure compliance with FDA, ISO 13485, EU MDR Lead CAPA investigations, non-conformance resolution, and process...Full time$95k - $120k
...Description Job Description Overview As a Quality Engineer, you will play a critical role in new... ...with FDA regulations, quality systems, and applicable industry standards. Qualifications... ...of FDA regulations, risk management, CAPA, SPC, FMEA, and root cause analysis...Permanent employmentContract work- Recruiter: Spencer Gregory HaleSenior Quality Systems EngineerAbout the role:The Senior Quality Systems Engineer provides technical leadership and subject matter expertise... ...:Lead and support QMS processes including CAPA, nonconforming events, internal audits, external...Hourly payWork at officeShift work3 days per week
$110k - $140k
...therapeutic technology and they're looking to add a Senior Supplier Quality Engineer to their team.This is a highly visible role supporting a... ...manufacturing experience * Strong knowledge of supplier audits, CAPA, root cause analysis, and supplier development * Experience...- ...progressing - whatever your ambitions. About This Role:The Senior Quality Systems Engineer of material controls will serve as a Quality representative... ...RequirementsOwnership of highly visible, global, systemic CAPAs while leading through a Community of PracticeProviding...Hourly payWork at officeLocal areaRelocation packageShift work3 days per week
$22 - $28 per hour
...maintenance equipment; turf irrigation systems; landscape and lighting products; snow... ...users. What Will You Do? The Advanced Quality Engineering Intern will partner with the Advanced Quality... ..., corrective and preventive action (CAPA) tracking, and continuous improvement...Hourly paySummer workCasual workInternshipSummer internshipWorldwideWork visaFlexible hoursWeekend work1 day per week$98.9k - $148.3k
...opportunities to work on revolutionary systems that impact people’s lives around the world... ...This position will provide Quality Engineering and Mission Assurance support to programs... ...with Corrective and Preventive Action (CAPA) / Root Cause Corrective Action (RCCA)....Contract workRelocationShift work- ...are seeking a qualified QA Validation Engineer to support quality assurance, process validation, and test... ...understanding of quality management systems and applicable regulatory requirements... ...of Corrective and Preventive Actions (CAPA). Maintain accurate quality records...
- ...great opportunities Position: Sr. Supplier Quality Engineer Location: Minneapolis, MN Duration:... ...cause analysis and implement effective CAPAs to address supplier quality issues.... ...QSR , and supplier quality management systems. Hands‑on experience with supplier qualification...Contract work
$120.8k - $181.2k
...help restore function, improve quality of life, and support better... ...collaborate to inspire as we engineer the extraordinary. Principal Quality... ...risk assessment, and quality system processes that help maintain... ...Corrective and Preventive Actions (CAPAs) and drive implementation of...H1bWork at officeLocal areaWorldwideFlexible hours- ...Medtronic Neuroscience is seeking a Principal Quality Engineer to lead Post Market Quality activities for Neuromodulation and Pelvic Health, driving investigations, CAPAs, risk assessment, and quality-system improvements to maintain safety and effectiveness of therapies...
- ...Job Description Job Description Quality Engineer What You’ll Be Part Of You will be part of... ...analysis and corrective/preventive actions (CAPA) • Support audits and ensure... ...Experience in quality engineering or quality systems • Knowledge of quality standards and...
- ...Description Job Description Job Summary Quality Engineer II to ensure that products,... ...engineering, nonconformance investigations, CAPA, complaint management, and root-cause analysis... ...effectiveness of the Quality Management System (QMS). Identify quality risks and...For contractors
- ...Katalyst-Healthcares- is seeking a QA Validation Engineer to support quality assurance, process validation, and test method validation in a regulated... ...apply PQ and method validation expertise and work with CAPA processes to maintain compliance. The role requires hands...
$85k - $110k
..., Minnesota is looking to hire a senior quality engineer to join their team. This Sr Quality Engineer... ..., complaint handling, and related CAPA activities. They should also have experience... ...strong QMS (Quality Management System), GMP (Good Manufacturing Practices), GDP...Contract work- ...Cretex Medical is seeking a Quality Systems Engineer to support and administer enterprise level QMS processes, including CAPA, audits, training, and standards library. You will ensure ISO 9001/13485 and FDA QSR compliance, develop and revise procedures, analyze data, and...
- ...EPM Scientific is seeking a Principal Quality Engineer to provide technical leadership across product development, manufacturing, and post-market... ...risk management and design controls. The role emphasizes CAPA investigations, process validation, and cross-functional collaboration...
$20.91 - $45.04 per hour
At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job Description : Job Overview Works under the supervision of administrative division management to gain ...Work experience placementSummer workInternshipLocal area- ...Quality Engineering ManagerIn this role, you will lead quality engineering activities for the ORV... ...develop strategies to strengthen quality systems and supplier relationshipsLead cross-... ...problem solving for quality events and drive CAPA implementationsCollaborate with...
$135k - $157.5k
...Join our innovative, mission-driven Quality team as a Staff Supplier Quality Engineer- Contract Manufacturing at... ...plans, ensuring technical, quality‑system, risk‑management, and regulatory impacts... ...nonconformances, investigations, CAPAs, and SCARs using data‑driven root...Contract workFor contractorsLocal areaWork from homeFlexible hours- The Principal Quality Engineer is responsible for providing technical leadership and quality engineering... .... Ensure compliance with FDA Quality System Regulation (21 CFR Part 820), ISO 13485,... ...nonconformances, customer complaints, CAPAs, and audit findings. Utilize structured...
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