Quality Systems Lead - Medical Devices & Regulatory Compliance
Dormont Manufacturing Co
Dormont Manufacturing Co in Beverly, MA is looking for a Quality Systems Manager to lead the development and management of compliant quality systems. The role requires strong experience in regulatory compliance, quality audits, and team leadership in a medical device environment. The ideal candidate will possess a Bachelor’s degree and at least 7 years of experience in Quality and Manufacturing, along with a successful track record in mentoring staff and managing audits. #J-18808-Ljbffr Dormont Manufacturing Co
$96k - $192k
...About this role As the Regulatory Affairs & Compliance Lead at Sensitech , you will be the regulatory subject... ...with Product Development, Quality, Manufacturing, Marketing, Legal,... ...of experience with hardware, IoT, medical devices, or regulated electronics 2+ years...QualityMedical deviceTemporary workWork at officeVisa sponsorship2 days per week- ...is seeking a seasoned Quality and Regulatory Affairs leader to drive compliance and quality strategy across... ...of experience in the medical device industry, showcasing... ...leadership in managing quality systems aligned with ISO 13485... ...quality systems, lead continuous improvement...QualityMedical device
$165k - $200k
...technology group is seeking a Director, Quality and Compliance in Beverly, MA. This role... ...of experience in quality and regulatory affairs within the medical device industry. The candidate should have... ...in ISO 13485 and FDA-compliant systems, and the ability to communicate...QualityMedical device- ...(USA) Senior Manager Quality Systems Hybrid - Beverly, MA... ...! Responsibilities: Lead the development, deployment... ...Ensure readiness for regulatory, customer, and... ...Develop and implement compliance risk assessment model... ...Regulatory Affairs within the medical device industry. Proven...QualityMedical device
$90k - $100k
...against ISO management system standards, primarily... ...management systems for compliance with applicable ISO requirements... ..., environmental, quality, industrial, or a... ...and safety management Medical device quality systems Manufacturing... ...ISO 13485 Completed Lead Auditor training for...QualityMedical devicePermanent employmentFull timeContract workFreelanceLocal area$94k - $151.8k
...Business Engagement Leads Job Category Professional... ...and Electrical Systems Categories. This... ...play a key role in regulatory and compliance initiatives which would... ...Distribution and/or Quality related field is advantageous... ...Acumen with Medical Devices (specifically Abiomed...QualityMedical deviceTemporary workLocal area$165k - $200k
...moments. Freudenberg Medical is a trusted... ..., delivering high-quality solutions from ideation... ...for medical device and pharmaceutical... ...Director, Quality and Compliance Responsibilities Qualifications... ...in Quality and/or Regulatory Affairs within the... ...FDA-compliant QMS systems. Knowledge of FDA...QualityMedical deviceContract workVisa sponsorship- ...maintain a Corporate quality strategy... ...expectations. Ensure compliance with ISO 13485,... ...operations. Lead continuous... ...supplier quality systems, quality... ...the Freudenberg Medical business. Develop... ...knowledge of medical device regulations and... ...with regulatory agencies, notified...QualityMedical device
- ...in accordance with J&J and regulatory standards. The role supports... ...Regulatory Affairs, Design, Quality, and Lifecycle to ensure labeling... ...accuracy, completeness, and compliance with country‑specific... ...collaboration. Exposure to medical devices, regulatory compliance, and...QualityMedical deviceLocal area
- ...Co in Beverly, Massachusetts is looking for a Quality Engineer to manage quality planning and compliance for medical manufacturing. Responsibilities include process... ...experience, and proficiency with quality management systems like SAP. Join our diverse and inclusive team...QualityMedical device
- ...Responsibilities Responsible for leading, development, and... ...of effective and compliant quality systems and work closely with various... ...representing site to all regulatory bodies including registered... ...experience. 5 years minimum of medical device experience. 5+ years...QualityMedical deviceFlexible hours
$122k - $212.75k
...production associates and key support areas, leading a global team of trainers and... ...initiatives with production, engineering, and quality teams. Responsibilities Lead, coach,... ...least 5 years of leadership experience. Medical device industry experience required. Required...QualityMedical deviceTemporary workWork experience placementWork at officeLocal area- ...you will serve as Site Quality Manager, responsible... ...Quality Assurance (QA) & Regulatory Compliance (RC). The role manages QA objectives, leads the quality team, and... ...Quality Management System (QMS). Process owner... ...authorities. What We Offer Medical, dental, and vision...QualityLocal area
- ...application process. AI Regulatory Manager W2... ...Healthcare and Medical Equipment) is... ...Tomography. We lead nationwide... ...of advanced CT systems used by healthcare... ...-as-a-medical-device (SaMD) portfolio... ...and ensuring compliance with evolving global... ...and building quality culture....QualityMedical deviceFull timeTemporary workWorldwideFlexible hours
- ...distribution of reusable medical devices and surgical... ...departmental policies and regulatory requirements. -Inspects... ...standardized tray listings and quality standards. -Utilizes instrument tracking systems to document processing... ...ideas, we choose to lead. All qualified...QualityMedical device
- We are seeking a skilled Medical Device Manufacturing Engineer... ...inspection methods, and quality documentation activities... ...supporting measurement system analysis activities. Candidates... ...inspection tools, ISO compliance, and medical device regulatory documentation. Roles &...QualityMedical device
$17.71 - $25.28 per hour
...experts, researchers, and systems analysts to advance... ...drive groundbreaking medical discoveries and... ...equipment, such as medical devices, instruments, and... ...Adhere to established quality control processes, including... ...specifications, and compliance with regulatory requirements....QualityMedical deviceHourly payRemote workShift work$120k - $140k
Position: Quality Manager - Responsible for leading, developing, and managing effective... ...compliant quality systems at Freudenberg Medical LLC, a global technology... ...members and works on regulatory compliance, audits, and... ...Minimum 5 years of medical device experience. 5+ years...QualityMedical deviceVisa sponsorshipFlexible hours- ...Senior Regulatory Affairs Specialist... ...and ultrasound systems. Our advanced medical technologies are... ...used worldwide in leading healthcare institutions... ...improve the quality of people's lives... ...submissions and compliance activities for our... ...digital X-ray medical devices. ESSENTIAL...QualityMedical deviceFull timeTemporary workPrivate practiceWorldwideFlexible hours
- ...with new, specialty devices that make it... ...Manufacturing Manager to lead our manufacturing... ...across safety, quality, delivery, productivity... ...with applicable regulatory standards,... ...Utilize ERP/MRP systems to support production... ...environment (e.g., medical devices, pharmaceuticals...QualityMedical deviceFull timeWorldwide
$109k - $174.8k
Senior Microbiology Quality Sterility Assurance... ...Manage a workplace in compliance with regulatory or company... ...relation to submissions. Lead MQSA remediation activities... ...into the quality system. Help establish formal... ...desirable; medical device experience preferred...QualityMedical deviceContract workWork experience placementWork at officeLocal areaImmediate start- Meet Life Sciences in Danvers, Massachusetts, is seeking a Senior Supplier Engineer to lead supplier development and ensure product quality across the lifecycle. This role will focus on electronic assemblies and manufacturing processes. The ideal candidate will have at...QualityMedical device
- ...Supplier Engineer in Danvers, Massachusetts. This role is pivotal in managing supplier relationships and ensuring quality in the electronics category. You will lead supplier initiatives and work on developing advanced cardiovascular technologies. The ideal candidate will...QualityMedical device
- ...Services, LLC is looking for a skilled Medical Device Manufacturing Engineer in Danvers, Massachusetts... ...validation, inspection methods, and quality documentation in a regulated... ...and strong skills in TMV protocols, ISO compliance, and precision measurement tools. This...QualityMedical device
$22.22 - $31.71 per hour
...Site: North Shore Medical Center, Inc. Mass General... ..., researchers, and systems analysts to advance our... ...distribution of reusable medical devices and surgical... ...policies and regulatory requirements.... ...standardized tray listings and quality standards. -Utilizes...QualityMedical deviceHourly payRemote workShift workNight shift- ...successful candidate will lead supplier development... ...and establish robust quality systems with key... ...continuity within a regulated medical device environment Principal... ...nValidation Testin Regulatory and Industry Knowledge... ...scale-u pRegulatory compliance requirements for...QualityMedical deviceWork at office
- ...is a wonderful opportunity to improve the quality of life for a young student.... ...individualized nursing care to a student with complex medical needs. * Monitor and support the student... ...hours. * Manage and care for medical devices including G-Tube, J-Tube, and Central Line...QualityMedical deviceInterim roleMonday to Friday
- Advantage Technical is seeking a Document Control & Regulatory Compliance Specialist in Beverly, Massachusetts to manage QMS documentation... ...will have experience with AS9100 and ISO 9001 quality management systems, strong technical writing skills, and proficiency in Microsoft...QualityWork at office
- ...introductions. This role leads the development and... ...(IQ/OQ/PQ), ensuring compliance and robust process performance... ..., Operations, and Quality to ensure a seamless... ...complies with quality system requirements and... ...regulated industries (medical devices highly preferred). Strong...QualityMedical device
$30 - $44.29 per hour
...manufacturing solutions for life science, medical devices, and pharmaceuticals. We provide custom... ...ensure safe, cost-effective operations Systems Management: Oversee maintenance and... ...actions Drive Excellence: Continuous growth Quality & Safety: Comply with safety rules and...QualityMedical deviceHourly payImmediate startRelocationWork visaRelocation packageFlexible hoursShift workNight shift
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality Systems Lead - Medical Devices & Regulatory Compliance. Be the first to apply!

