Quality Systems Engineer III
Katalyst HealthCares & Life Sciences
Job-ID32475020Reference26-01044Remote50% Remote Job Description: Responsible for ensuring compliance with established requirements and standards for products and processes through effective implementation of the Quality Management System (QMS). The position is responsible for supporting the global development, implementation, and continuous improvement and harmonization of the local Quality Management System (QMS) in compliance with applicable medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, IEC 62304 and EU MDR as well as corporate procedures and requirements. What You Can Expect How You'll Create Impact Principal Roles and Responsibilities: Support cross-functional teams in the harmonization and standardization of quality procedures, tools, and best practices across sites and regions. Complete gap assessments for local procedures against corporate procedures, requirements and applicable medical device regulations and standards. Collaborate with cross functional team members to align & execute updates to local procedures to align with applicable requirements. This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act. What Makes You Stand Out Expected Areas of Competence (i.e., knowledge, skills and abilities) Extensive knowledge of global regulatory requirements for medical devices, including 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971. Skilled in developing and implementing procedures for various QMS elements including but not limited to purchasing controls, design controls, nonconformance management, validation, and corrective and preventive actions (CAPA). Familiarity with quality tools and methodologies (e.g., Six Sigma, root cause analysis, risk management, SPC, FMEA). Strong communication and collaboration skills, with the ability to influence and drive alignment across diverse stakeholders (R&D and Regulatory). Preferred experience with enterprise quality systems and ERP systems (e.g., SAP, EtQ). Must have previous Medical Device Experience Preferred experience with SaMD (Software as a medical device) and class II medical devices. Requirements: Your Background Education/Experience Requirements High school diploma or equivalent required. Bachelor's degree in Engineering preferred. Technical, engineering, and/or scientific background is strongly preferred. Minimum 5+ years of experience in Quality/Regulatory Compliance or related field required CQE or equivalent certification preferred. Must be familiar with Microsoft Office Suite.
- ...Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers... ...our employees experience every day.The Quality Engineer develops, establishes and maintains quality engineering methodologies, systems and practices that meet Boston Scientific...SuggestedHourly paySummer workRemote workRelocationRelocation packageShift work
- The Compliance Engineer III (Electronics) ensures that products meet all applicable UL safety standards and FCC electromagnetic compatibility... ..., and regulatory constraints in complex electronic control systems.This position will serve Rheem North America, located in...SuggestedContract workWork at officeRemote workWorldwideMonday to Thursday
- ...talented Team.Job Title: Implementation Engineer / Telecommunications Engineer - IIILocation... ...Engineer / Telecommunications Engineer - III is responsible for performing detailed... ...and airflow.Create workflows in required systems and communicate issues to lead engineers....Suggested
$100k - $130k
...Overviewdormakaba is seeking a Manufacturing Engineer III based in Indianapolis, IN. The... ...processes, equipment performance, and product quality while serving as a technical resource... ...equivalent advanced trainingFamiliarity with ERP systems (e.g., SAP 4 Hana), CAD software, and...SuggestedTemporary workWorldwide- ...is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed... ....Job Description:Validation Engineer III Who You’ll Work With You will join... ...experts to deliver the highest quality solutions to our clients with consistency...SuggestedFull timeWork at officeFlexible hours
$54k - $58k
...Participates in the quality assurance (QA) activities of a project which may include test case, requirements and design reviews. Executes... ...Experience with Functional Testing, Integration Testing, System Testing, and User Acceptance Testing phases. Experience with...Contract workWork at office- ...unique opportunity to join INCOG BioPharma’s Quality Assurance team in a highly visible role... ...Reporting to the QA Director of Quality Systems, you will be part of a collaborative,... ...this is the role for you.The QA Senior Engineer of Inspection, Labeling, and Packaging is...Contract workWorldwide
$100k - $150k
Hanson Values Integrity | Commitment | Quality | Relationships | InnovationIf you’re looking for a firm that encourages innovative thinking... ...and our environment.A Day in the Life of an Air Quality Engineer at HansonHere’s a snapshot of what you would do in this role:Lead...Full timeInternshipLocal area- ...and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact -... ...Business System which makes everything possible.The Supplier Quality Engineer is responsible for driving supplier quality performance, leading...Full timeWork experience placement
- ..., qualification, and commercialization of drug delivery systems for biomedical products. We deliver integrated business... ...Solutions Group - Adjutant Solutions Group LLC website. QA Engineer Role Summary The Quality Assurance Engineer provides Quality Assurance support...Full time
- ...Linde Advanced Material Technologies Inc. Quality Engineer I Indianapolis, IN, United States What you will enjoy doing* You will support the... ...related experience with 2+ years of direct AS9100 Quality system related experience You must be able to communicate professionally...Permanent employmentWork at officeWeekend work
- ...an exceptional customer service professional to join us as a Quality Engineer. As the leading supply chain solutions business in the aerospace... ...aerospace manufacturing processes, AS9100 Quality Management Systems; Blueprint Reading, Geometric Dimensioning and Tolerancing...Full timeContract workWork at office
- ...Location: Indianapolis, IN, US, 46250 Date: Sep 5, 2026 Quality Engineer Job Description The Quality Engineer supports Comecer... ..., VPHP generators for sterilization, solid target processing systems, dose calibrators, glove testers, and VPHP sterilization modules...Work at office
- ...Quality Engineer The Quality Engineer is responsible for supporting the development, implementation, and continuous improvement of the company's Quality Management System (QMS). This role partners with cross-functional teams to establish standardized quality processes...Work at office
- ...Position Summary: The Supplier Quality Engineer is the focal point between MTM and suppliers. They are responsible for supplier development... ...00+ skilled employees, best-in-industry business and quality systems, and project management expertise. Located for easy access on...Contract workTemporary workWork at officeImmediate startFlexible hours
- Salesforce Manual QA TesterDuration: 18+ months. Long term projectLocation: Remote. Client is in Carmel, INResponsibilities:Functional TestingFull Test Regression Creator and ExecutorUser Stories AnalysisTest Cases CreationDefect ReportingTest planning and strategyKPI ...Remote work
- ...responsibility, and professionalism.The Quality Assurance Technician is responsible for... ...standardsReport any product defects and system non-conformancesVerify that procedures meet... ...mentor Quality Inspectors and Quality Engineers on measurement techniques and analysis methodologiesInteract...
$68.49k - $142.25k
...private defense and government solutions business specializing in advanced technology systems and mission support. Its capabilities include data science, software development, network engineering, intelligence, surveillance, and reconnaissance (ISR), and logistics. Job...Full timeContract workWork at officeRemote workMonday to FridayWeekend workAfternoon shift- ...are starting (or restarting) their careers As a Quality Engineering Intern, your job is the most important in ensuring patient safety... ...and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements...Hourly payInternshipWork at officeLocal areaRelocation packageShift work
$90k - $100k
...PACKAGES ARE AVAILABLE FOR QUALIFIED CANDIDATES* LHH is seeking a Quality Engineer for a Direct Hire, Permanent Placement position with an... ...Utilize and maintain the Quality Management System (QMS) to meet industry and customer standards Conduct inspections...Permanent employmentContract workLocal areaRelocation- Overview The Quality Engineer is responsible for improving the quality of products by working with Design, Manufacturing, and other functions... ...and define process control requirements and measurement systems; create and improve control plans Identify sources of variation...
- ATS Company: Comecer
- ...ampere individuals to join our team! Job Description The Quality Engineer will, under the general direction of the Quality Manager,... ...documentation following internal company protocols and material ID systems, including collection and preparation of COC/COA for...Contract workLocal areaRelocation
- ...the founding members of a new Operations Engineering NPI team in Indianapolis, chartered with... ..., and automated fiber certification systems — from R&D into volume manufacturing. This... ...fiber optic test instruments.Statistical Quality Control: Implement Gauge R&R, Cpk, and Measurement...Full timeContract workRemote workWork from home
- ...and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact -... ...Business System which makes everything possible.The Staff Supplier Quality Engineer is responsible for ensuring the quality of processes and...Full timePart timeWork at office
- ...reproducible, and compliant? INCOG BioPharma's Quality Assurance team is expanding, and we're... ...cycle.The Senior QA Process Validation Engineer, II provides QA oversight of Process... ....If you crave the challenge of creating systems from scratch and believe you have insights...Full timeH1bVisa sponsorshipWork visa
- ...in global energy. AES Indiana is looking for a NERC Compliance Engineer to help strengthen the reliability, safety, and performance of... ...audits, spot checks, and self-certifications.Analyze protection system settings, generator performance models, and operational data to...Full timeFor contractorsWorldwide
- ...respect, responsibility, and professionalism.We are seeking a Senior Hardware Quality Engineer (HQE) to fill a key role on our Indianapolis team. This position ensures that hardware systems meet rigorous quality standards and customer expectations. The HQE will lead quality...Contract work
- ...Job Description About ALOM ALOM is a quality- and technology-driven global supply chain... ...ALOM is looking for a Quality Engineer to join our Supplier Quality team. You'll... ...qualification Keep supplier and quality system records complete, accurate, and audit-ready...Contract workTemporary workWork at office
- ...Allison Transmission and Allison Off-Highway Drive and Motion Systems business units, our team strives to Improve the Way the World... ...assistance programJob Description:Primary Purpose of Role:As the Engineering Operations Senior Test Equipment Engineer, you will be...Full timeWork at officeLocal areaImmediate startWorldwide
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