Qms Engineer Jobs

QMS Engineer — Hiroshima - Fab 15, Japan. Apply via Workday.

QMS Engineer — Tainan, Taiwan. Apply via Workday.

Fab10 QEM Quality Management System (QMS) Engineer — Fab 10N/X, Singapore. Apply via Workday.

What you’ll do Own and evolve the Quality Management System (QMS) to support a regulated medical device development program, including design controls and DHF maintenance. Establish and enforce requirements traceability: user needs → design requirements → verification/validation artifacts and change control. Define and run the program-level V&V strategy (verification, validation, and test coverage), including test plans, protocols, reports, and acceptance criteria. Drive risk management activities (e.g., DFMEA / PFMEA, hazard analyses) and ensure mitigations are reflected in requirements and verification. Lead document control: reviews, approvals, training, retention, and audit readiness. Partner with engineering to make quality “native” to the dev workflow (automated testing, release gates, software configuration management). Prepare the program for audits and inspections, including hands-on audit leadership. What we’re looking for Senior experience leading quality for complex hardware + software products in a regulated environment. Deep familiarity with design controls, DHF, document control, risk management, and verification planning. Strong systems thinking and the ability to translate ambiguous product intent into testable requirements. Comfortable collaborating directly with multidisciplinary engineering (recon/ML, embedded, mechanical, EE, cloud). Useful experience Regulated product quality leadership (ISO 13485 / 21 CFR 820 or equivalent), including audit readiness and FDA-facing work. eQMS + document control fluency (e.g., Greenlight Guru) that integrates cleanly with modern engineering workflows.

Work Flexibility: Hybrid The Senior Quality Management System Specialist will help design, maintain, and continuously improve a quality management system that supports regulatory approval and business growth across global markets. You’ll collaborate across functions to ensure quality processes are not only compliant, but practical, efficient, and future‑ready. Activities include Quality System documentation, Internal Quality Agreements, Supplier Quality Agreements, and general QMS activities related to Mergers and Acquisitions. This role is Hybrid in Portage, Michigan . What You Will Do Support and maintain a compliant Quality Management System aligned with global medical device regulations to enable product certification and regulatory clearances. Develop and update quality system processes, procedures, and documentation to reflect business needs and regulatory expectations. Assess and quantify quality system requirements to optimize structure, integration, and scalability. Identify and implement continuous improvement opportunities that increase efficiency and effectiveness of quality processes. Support management review, quality planning forums, and related governance activities with data-driven inputs. Partner with stakeholders to ensure quality processes reflect actual operational activities, including support for new product development. Prepare for and support internal, external, and third‑party quality system audits, including responses and follow‑up actions. Contribute to quality system training content and delivery to ensure effective adoption across the organization. What You Will Need Bachelor’s degree in science, engineering, business, or a related discipline. <

We anticipate the application window for this opening will close on - 5 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72&#43; million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working onsite 5 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. The Senior Quality Systems Specialist will serve as the primary interface between Medtronic and external customers for a designated business, while owning and optimizing the Quality Management System (QMS) processes that support customer-related activities. This role combines hands-on customer support (orders, changes, complaints, RMAs) with end-to-end responsibility for designing, maintaining, and improving quality processes, metrics, and documentation in alignment with ISO 13485 and FDA requirements. Responsibilities may include the following and other duties may be assigned. Customer-Focused Quality Systems and Process Ownership Optimize and enhance existing Tempe Medtronic frameworks that support customer-related activities to ensure alignment with ISO 13485, FDA requirements, and internal quality system standards. Establish, track, and continuo

Instawork is on a mission to create meaningful economic opportunities for skilled hourly professionals in communities around the globe. Our AI-powered labor marketplace helps local businesses scale, and enables global technology companies to push the frontiers of robotics and AI. Backed by world-class investors like Benchmark, Spark Capital, Craft Ventures, Greylock, Y Combinator, and others, we’re looking for exceptional talent to reimagine the way the world works. About IRL (Instawork Robotics Labs) Researchers at UC Berkeley have identified a “100,000-year data gap” - the gulf between what trained AI language models and what physical robots actually have to learn from. Closing that gap is the defining infrastructure challenge of the physical AI era. IRL is Instawork’s answer to it. We deploy skilled workers into real commercial and residential environments - kitchens, warehouses, hotel floors, homes - to capture the high-fidelity task data that the world’s leading Robotics labs use to train their foundation models. Read more here . What you’ll do Lead Workforce & Operations: Drive day-to-day workforce management for Clippers, Graders, Regraders, SMEs, and ICs across shifts/sites, optimizing staffing, capacity planning, and throughput against SLA targets. Implement Quality Systems & Methods: Maintain the QMS and apply structured methods (RCA, CAPA, FMEA, 8D, SPC) to address recurring defects, calibration drift, gold-sample injections, and consensus checks. Own SOPs & Process Standards: Build, version-control, and continuously iterate SOPs for existing and new program launches, ensuring floor adoption and structured QA onboarding/re-calibration paths. Bridge Cross-Functional Teams: Translate engineering data requirements into floor-executable QA criteria, report field issues back with evidence, and represent QA in program launches and crisis calls. Drive Data-Led Quality: Monitor and analyze key QA metrics—defect/reject rates, inter-grader agreement (ka

Manager - QMS — Sanand - 303A - AT/SSD/MOD, India. Apply via Workday.

Technologist - QEM Quality Management System (QMS) — Fab 10N/X, Singapore. Apply via Workday.

Technician, Quality Management System (QMS) — 2 Locations. Apply via Workday.

Job Title Quality Control Technician Job Description In this role you Are responsible for supporting diverse complex quality control tasks, assisting in resolving malfunctions, analyzing quality control improvements. Your role: •Helps to execute diverse complex tasks based on individual understanding and technical knowledge to address abnormalities within operational manufacturing processes. •Assists in remedying complex malfunctions, helps to execute product quality inspection activities within the project scope. •Aids to implement quality control procedures and protocols, ensuring adherence to good laboratory practices (GLP) and good manufacturing practices (GMP). •Helps in the documentation of regulatory requirements for good manufacturing controls for medical devices as outlined in quality control plans, assisting in implementing the laboratory chemical hygiene program. •Provides support towards the execution of validation protocols and testing methods for new products and processes to ensure they meet quality standards. You're the right fit if: You have a High School Diploma or Vocational Education Prefer 2&#43; years of experience with Quality Control, Inspection, QMS, Technical documentation, Manufacturing in medical device. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this <a target="_blank" href="https://eur01.safelinks.protection.outlook.com/?url&#61;https%3A%2F%2Fwww.careers.philips.com%2Fna%2Fen%2Foffice%2Fremote-sedentary-work-physical%2C-cognitive-and-environmental-pce-job-requirements&data&#61;05%7C02%7Cvenkata.damaraju%40philips.com%7Cc673b7f662d14a95a61708dc704f3d4b%7C1a407a2d76

Work Flexibility: Onsite Stryker is hiring a Senior CAPA Specialist for the Joint Replacement division in Mahwah, NJ. Working within the QMS team to ensure compliance with CAPA processes and procedures and is responsible to but not limited to. Have responsibility for review and approval of NC and CAPAs, with attention to detail, review for completeness, accuracy, effectivity and timeliness. Review & Approval of CAPA changes including extension requests. What you will do · As Problem Solving Methodology expert, facilitate and coach NC & CAPA teams in the application of problem-solving techniques and promote its use and development e.g. Human Error Reduction, 4-D etc. Support Nonconformance (NC) and Corrective and Preventive Action (CAPA) activities by partnering with cross-functional teams to drive timely investigations and resolution of quality issues. Apply CAPA, root cause analysis, and problem-solving methodologies to support effective corrective and preventive actions. Maintain accurate and complete CAPA documentation within electronic quality management systems (e.g., TrackWise), ensuring required evidence and records are documented. Assist in facilitating CAPA review meetings and contribute to site, cross-functional, and global quality discussions. Monitor CAPA metrics and trends, prepare reports and provide data to support quality and business reviews. Provide guidance and support to CAPA process stakeholders, promoting consistent application of quality system requirements and procedures. Participate in training, process improvement, and continuous improvement initiatives to enhance CAPA effectiveness and compliance. Support internal, corporate

Head - QA/QC is responsible for quality assurance and quality control processes for all construction and city-side development projects. This role involves designing and implementing Quality Management Systems (QMS), methodologies, Quality strategy, conducting regular quality audits, and leading the QA/QC team through comprehensive training and professional development. Source: Adani Group | Job ID: 48821

Senior Internal Auditor BGS Vertical Lift (Quality Systems Specialist) Company: The Boeing Company Boeing Global Services (BGS) is looking for a Senior Internal Auditor BGS Vertical Lift (Quality Systems Specialist) to join their Vertical Lift Quality Team in Mesa, AZ. This position will focus on supporting Vertical Lift Quality organization. Position Responsibilities: · Create and maintain the site Internal Audit Schedule · Maintain the site Internal Audit Program per AS9100 requirements · Promotes a healthy Quality Management System (QMS) rooted in process-based management methodologies · Performs process risk assessments · Writes Internal Audit reports and documents process non-conformance · Support process owners with corrective action process requirements · Performs and oversees Internal Audits – conduct assessments of processes and practices for comparison to applicable standards and requirements. · Maintain Internal Audit monthly metrics/KPIs · Provide monthly Internal Audit performance to the DQMR · Identified as the Process Owner for the Internal Audit Program that resides in the local Quality Management System · Align CAPA process with company and AS9100 requirements for Corrective Actions · Recommend and implement changes to the existing Internal Audit Program · Assist our business unit across Vertical Lift sites with continuous improvements and or lean projects · Use data for analysis trends and opportunities for improvement · Use experience and knowledge relative to all methods of Root Cause Corrective Actions, e.g., 5-Why, Fish bone, Boeing Problem Solving Model (BPSM)</

Job Title Quality Control Technician Job Description In this role you Are responsible for supporting diverse complex quality control tasks, assisting in resolving malfunctions, analyzing quality control improvements. Your role: •Helps to execute diverse complex tasks based on individual understanding and technical knowledge to address abnormalities within operational manufacturing processes. •Assists in remedying complex malfunctions, helps to execute product quality inspection activities within the project scope. •Aids to implement quality control procedures and protocols, ensuring adherence to good laboratory practices (GLP) and good manufacturing practices (GMP). •Helps in the documentation of regulatory requirements for good manufacturing controls for medical devices as outlined in quality control plans, assisting in implementing the laboratory chemical hygiene program. •Provides support towards the execution of validation protocols and testing methods for new products and processes to ensure they meet quality standards. You're the right fit if: You have a High School Diploma or Vocational Education 2&#43; years of Quality Control experience. Prefer experience with Inspection, QMS, Technical documentation, Manufacturing in medical device. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this <a target="_blank" href="https://eur01.safelinks.protection.outlook.com/?url&#61;https%3A%2F%2Fwww.careers.philips.com%2Fna%2Fen%2Foffice%2Fremote-sedentary-work-physical%2C-cognitive-and-environmental-pce-job-requirements&data&#61;05%7C02%7Cvenkata.damaraju%40philips