Talent.com
Medical Device QMS Audit Manager
Medical Device QMS Audit ManagerSGS • Miami, FL, US
Medical Device QMS Audit Manager

Medical Device QMS Audit Manager

SGS • Miami, FL, US
25 days ago
Job type
  • Full-time
Job description

Medical Device QMS Audit Manager

Location : Remote within Europe

We are SGS the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,500 employees operate a network of 2,500 offices and laboratories, working together to enable a better, safer and more interconnected world.

Job Description

We are seeking a knowledgeable and driven Medical Device QMS Audit Manager to lead and oversee the training, qualification, and compliance processes for QMS Auditors involved in our medical device conformity assessments. This non-clinical role plays a vital part in ensuring the competence of technical personnel and the continued regulatory compliance of SGS Notified Body 1639.

Your Mission

As Technical Team Manager, you will :

  • Lead the development and delivery of training and qualification frameworks for technical staff (excluding clinical).
  • Establish and maintain competence criteria, monitor qualification status, and approve audit and assessment activities.
  • Provide expert technical guidance across the entire conformity assessment process and contribute to the development of QMS documentation aligned with EU regulations and best practices.
  • Support operational, technical, and strategic initiatives to maintain the integrity and effectiveness of SGS medical device services.
  • Work closely with the Medical Devices Management Team to stay abreast of regulatory changes and align internal processes accordingly.

Key Responsibilities

  • Design and manage training programs for QMS Auditors, globally.
  • Approve Level 1 audits and witness audits for auditor qualification and requalification.
  • Contribute to recruitment, onboarding, and approval of new personnel.
  • Develop and maintain QMS documentation aligned with MDR, IVDR, NBOG, and MDCG guidance.
  • Ensure competence, compliance, and operational efficiency across assessment teams.
  • Provide technical support across SGS NB 1639 activities and contribute to business development
  • Qualifications

  • Education : Bachelor's degree (or equivalent) in medicine, pharmacy, engineering, or related scientific field.
  • Experience :
  • 10+ years in the medical device industry, including at least 5 years in R&D or manufacturing roles.

  • Minimum 4 years working within a Notified Body.
  • Minimum 2 years leadership experience
  • Prior qualification as a Lead Auditor under MDR and / or IVDR.
  • Strong background in QMS auditing, technical file assessment, and applicable standards (ISO 13485, ISO 14971, etc.).
  • Skills :
  • Deep technical knowledge of non-clinical aspects of medical device conformity assessment.

  • Proven ability to develop and deliver effective training.
  • Strong understanding of EU regulatory frameworks and best practice guidance.
  • Excellent stakeholder engagement, problem-solving, and communication skills
  • Additional Information

    Why SGS?

  • Opportunity to work with a global leader in inspection, verification, testing, and certification.
  • Collaborative and inclusive work environment.
  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • Join Us : At SGS, we are dedicated to fostering an open, friendly, and supportive culture that thrives on teamwork. We value diversity and provide endless opportunities to learn, grow your expertise, and fulfil your potential.

    Create a job alert for this search

    Qms Manager • Miami, FL, US

    Related jobs
    Senior Manager, Business Development, Cell & Gene Therapies

    Senior Manager, Business Development, Cell & Gene Therapies

    Fresenius Kabi USA, LLC • Miami, FL, United States
    Full-time
    The Senior Manager, Business Development, will play a critical role in driving global sales and business development strategy for our cutting-edge Cell and Gene Therapies (CGT) Technologies divisio...Show more
    Last updated: 30+ days ago • Promoted
    Underwriter - Miscellaneous Medical & Life Sciences - South Region

    Underwriter - Miscellaneous Medical & Life Sciences - South Region

    Beazley Group • Miami, FL, United States
    Full-time
    Underwriter - Miscellaneous Medical.As per Beazley's organisation chart.Brokers, Underwriters, Claims staff, Coverholders, external Clients and Suppliers. To underwrite a Miscellaneous Medical & Lif...Show more
    Last updated: 13 days ago • Promoted
    FSED Emergency Medicine Medical Director

    FSED Emergency Medicine Medical Director

    HCA Healthcare • Miami, FL, US
    Full-time
    HCA Florida Kendall South Dade FSED is seeking FT board certified EM Medical Director to join this premier practice along the Florida Atlantic Coast in Miami and cover 2 FSED's at Cutler Bay and Ho...Show more
    Last updated: 25 days ago • Promoted
    Emergency Medicine Medical Doctor, Jackson West Medical Center, Doral, FL, Per-Diem

    Emergency Medicine Medical Doctor, Jackson West Medical Center, Doral, FL, Per-Diem

    Jackson Health System • Miami, FL, US
    Full-time
    Jackson West Medical Center Emergency Department.NW 79th Avenue, Doral, FL 33122.Variable days / nights (Per-Diem).Why Jackson West Medical Center. We have created a state-of-the-art environment where...Show more
    Last updated: 12 hours ago • Promoted • New!
    Sr. Access & Reimbursement Manager - (Miami FL)

    Sr. Access & Reimbursement Manager - (Miami FL)

    Eisai • Miami, FL, United States
    Full-time
    At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission.We're a growing pharm...Show more
    Last updated: 30+ days ago • Promoted
    Senior Project Manager - Oncology / Hematology (Phase III)

    Senior Project Manager - Oncology / Hematology (Phase III)

    Syneos Health / inVentiv Health Commercial LLC • Miami, FL, United States
    Full-time
    Senior Project Manager - Oncology / Hematology (Phase III).Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We translate uniqu...Show more
    Last updated: 17 days ago • Promoted
    UMMG Staff Physician - Pathology and Laboratory Medicine

    UMMG Staff Physician - Pathology and Laboratory Medicine

    University of Miami Health System • Miami, FL, US
    Full-time
    Board Certified or Board eligible in Anatomic Pathology, or Anatomic and Clinical Pathology.Must be licensed to practice medicine in the State of Florida. Knowledge, Skills and Abilities : .Strong kno...Show more
    Last updated: 25 days ago • Promoted
    Clinical Faculty, Open Rank - Medicine, Cardiology (Adult Medical Director of Clinical Advanced Heart Failure / MCS / Transplant Program)

    Clinical Faculty, Open Rank - Medicine, Cardiology (Adult Medical Director of Clinical Advanced Heart Failure / MCS / Transplant Program)

    University of Miami Health System • Miami, FL, US
    Full-time
    The department of Medicine, Cardiology has an exciting opportunity for a Clinical Faculty, Open Rank - Medicine, Cardiology (Adult Medical Director of Clinical Advanced Heart Failure / MCS / Transplant...Show more
    Last updated: 25 days ago • Promoted
    Patient Navigator Manager

    Patient Navigator Manager

    Syneos Health / inVentiv Health Commercial LLC • Miami, FL, United States
    Full-time
    You provide the vision, set the pace, and inspire success.There's one thing you do that's exceptional : lead.You formulate a plan and focus on your team to solve the unsolvable, beat the unbeatable ...Show more
    Last updated: 30+ days ago • Promoted
    Join a Prestigious Team in Pathology & Laboratory Medicine at UM

    Join a Prestigious Team in Pathology & Laboratory Medicine at UM

    University of Miami Health System • Miami, FL, US
    Full-time
    The University of Miami Health System is seeking a dedicated.Pathology and Laboratory Medicine.This role involves direct patient care with a primary focus on. UMH, JMH, SCCC, and satellite locations...Show more
    Last updated: 25 days ago • Promoted
    Pathology Anatomic and Clinical Medical Director

    Pathology Anatomic and Clinical Medical Director

    HCA Healthcare • Miami, FL, US
    Full-time
    Pathology Anatomic and Clinical.HCA Healthcare Pathology Services and their East Florida Division is seeking a Pathology Medical Director to be based at HCA Florida Mercy Hospital in Miami, FL.HCA ...Show more
    Last updated: 25 days ago • Promoted
    Physical Measurements Sales Representative

    Physical Measurements Sales Representative

    Shimadzu Scientific Instruments • Miami, FL, United States
    Full-time
    Physical Measurements Sales Representative.Established in 1975, Shimadzu Scientific Instruments is one of the largest suppliers of analytical instrumentation, physical testing, and environmental mo...Show more
    Last updated: 30+ days ago • Promoted
    Director, Clinical Quality Assurance

    Director, Clinical Quality Assurance

    Eisai • Miami, FL, United States
    Full-time
    At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission.We're a growing pharm...Show more
    Last updated: 30+ days ago • Promoted
    Travel Nurse RN - Case Manager in Tallahassee, FL

    Travel Nurse RN - Case Manager in Tallahassee, FL

    TravelNurseSource • Miami, Florida, US
    Full-time +1
    TravelNurseSource is working with Infojini Healthcare to find a qualified Case Manager RN in Tallahassee, Florida, 32301!. Self Assessment (Skills Checklist).At Infojini Healthcare, We tell it like ...Show more
    Last updated: 30+ days ago • Promoted
    Medical Director

    Medical Director

    AIDS Healthcare Foundation • Miami, FL, US
    Full-time
    AIDS Healthcare Foundation is public health, mission-based organization with a network of services that include healthcare centers, pharmacies and wellness clinics. We are now looking for a family p...Show more
    Last updated: less than 1 hour ago • Promoted • New!
    Operations Manager

    Operations Manager

    Fenagh Engineering and Testing • Miami, FL, US
    Full-time
    Fenagh Engineering & Testing is seeking an experienced and results-driven Operations Manager to lead our growing team in Miami. This is a key leadership position responsible for overseeing day-t...Show more
    Last updated: 30+ days ago • Promoted
    Clinical Faculty, Open Rank - Medicine, Nephrology (Medical Director, Living Donor Kidney Transplant Program)

    Clinical Faculty, Open Rank - Medicine, Nephrology (Medical Director, Living Donor Kidney Transplant Program)

    University of Miami Health System • Miami, FL, US
    Full-time
    Miami Transplant Institute is seeking a Medical Director of the Living Donor Kidney Transplant program.This individual will be responsible for partnering with medical and surgical leaders to struct...Show more
    Last updated: 25 days ago • Promoted
    Bid Manager

    Bid Manager

    Americaribe LLC • Miami, FL, US
    Full-time
    At Americaribe, we are more than builders—we are innovators, problem-solvers, and teammates.Building for Life means creating structures that stand the test of time while fostering a workplace...Show more
    Last updated: 23 days ago • Promoted