Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Medical Device QMS & BSI Audit Readiness Lead

VOLTO Consulting

VOLTO Consulting is looking for a qualified candidate to oversee BSI readiness audits in Austin, Texas. You will be responsible for planning, scoping, and leading mock audits for a variety of medical device manufacturers, ensuring compliance with ISO 13485:2016 and EU MDR 2017/745. The ideal applicant should possess a Bachelor's degree in a relevant field and at least 8 years of experience in Quality Assurance or Regulatory Affairs. Strong analytical skills and the ability to provide constructive feedback are a must. #J-18808-Ljbffr VOLTO Consulting

Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Medical Device QMS & BSI Audit Readiness Lead in Austin, TX vacancy
  • Job-ID32324519Reference26-00718Job Summary: QMS Consultant responsible for planning, scoping, and leading comprehensive mock audits to assess readiness for an upcoming BSI notified body audit. Evaluate the medical device manufacturer's Quality Management System (QMS) against... 
    Medical device
    Immediate start

    Katalyst Healthcares & Life Sciences

    Austin, TX
    4 days ago
  • $155k - $410k

     ...knowledge, and experiences you need to lead and deliver value at this level include...  ...standards (e.g. refer to specific PwC tax and audit guidance) the Firm's code of conduct,...  ...Pharma, Bio Pharma, & Specialty Pharma; Medical Device, Medical Technology & Diagnostics;... 
    Medical device
    Full time
    Temporary work
    H1b

    PwC

    Austin, TX
    2 days ago
  • $162.9k - $271.5k

     ...Use Your Power For Purpose The GMP/GDP Audit Lead position is responsible for leading the design, delivery and maintenance of audit...  ...key technology or business aligned areas: sterile biologic, medical device (including software as a medical device and digital health and... 
    Medical device
    Permanent employment
    Contract work
    H1b
    Local area
    Remote work
    Visa sponsorship
    Work visa
    Relocation package

    Pfizer

    Austin, TX
    20 hours ago
  •  ...& Responsibilities : Lead design transfer and production...  ...with manufacturing readiness. Own multiple...  ...drive CAPA within the QMS framework. Develop and...  .... Interpret and apply medical device regulations and standards...  ...and processes. Support audits and regulatory inspections... 
    Medical device
    Remote work

    Katalyst Healthcares & Life Sciences

    Austin, TX
    1 day ago
  • ICON is seeking a Senior Manager, Corporate Accounting to lead the high‑volume monthly close and deliver audit‑ready financials. You will oversee accounts payable, accruals, leases, fixed assets, payroll, and the general ledger while building a scalable team of professionals... 
    Suggested

    Iconcareers

    Austin, TX
    3 days ago
  •  ...innovation-driven medical technology growth company...  ...projects.Lead design and manufacturing...  ...Management System (QMS) requirements and applicable...  ..., and regulatory audits, including FDA, ISO...  ...within the medical device industry or another...  ...problemsAudit-Ready Mindset -... 
    Medical device
    Full time
    H1b
    Work at office

    Enovis

    Austin, TX
    2 days ago
  • $86.7k - $173.3k

     ...technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our...  ...education programs, ensuring all activities are audit-ready; support audits, investigations, and corrective... 
    Medical device
    Work at office
    Local area
    Shift work

    Abbott

    Austin, TX
    4 days ago
  • $95k - $145k

     ...role supports system validation strategy, audit readiness, CAPA management, and risk-based...  ...Forensic team, you will be responsible for… Lead end-to-end validation activities for...  ...environment, including pharma, biotech, medical device, or clinicalExperience leading validation... 
    Medical device
    Remote work
    Visa sponsorship

    Deloitte

    Austin, TX
    2 days ago
  • $179.7k - $243.1k

     ...Build the Quality Management System (QMS) from the ground up, define quality policies...  ...standards before production release. Lead quality readiness for New Product Introductions (NPI),...  ...Experience in automotive, aerospace, medical devices, or other advanced hardware... 
    Medical device
    Flexible hours

    Amazon

    Austin, TX
    3 days ago
  •  ...Enovis Corporation in Austin, TX is seeking a Medical Device Quality Engineer to support quality assurance activities, ensuring safety, quality...  ...and validation activities. The candidate will participate in audits, trend analysis and documentation efforts, with a focus on... 
    Medical device

    Enovis Corporation

    Austin, TX
    20 hours ago
  • $71k - $145.22k

    The Texas State Auditor's Office is hiring an Audit Project Manager responsible for managing complex audit projects and ensuring compliance with state laws. The role includes leading audit teams and coordinating resources to complete audits efficiently within deadlines... 
    Work at office

    Texas State Auditor's Office

    Austin, TX
    5 days ago
  •  ...safety, reliability, and compliance of medical device products. The role will support production...  ...continuous improvement, and support audits and corrective actions.Key ResponsibilitiesPerform...  ...with quality management systems (QMS) and electronic records systems (e.g., ERP... 
    Medical device

    CyberCoders

    Pflugerville, TX
    4 days ago
  •  ...Ready to Redefine Mental Healthcare? Join Serenity. If you're a psychiatrist...  ...treat — if you're ready to lead, innovate, and elevate care —...  ...Provide meaningful care with medication, TMS, and ketamine therapy—all...  ...Are: Using advanced medical devices recently released to market,... 
    Medical device
    Flexible hours

    Serenity Healthcare, LLC

    Austin, TX
    1 day ago
  •  ...catalyze global market growth and launch Amulet 360. You will lead strategy, coordinate regional teams, and drive adoption...  ...strong cross-functional leadership, a track record with medical devices, and a readiness to travel globally (25-30%). #J-18808-Ljbffr Abbott Laboratories... 
    Medical device

    Abbott Laboratories company

    Austin, TX
    1 day ago
  •  ...through effective implementation of the Quality Management System (QMS). The position is responsible for supporting the global...  ...Quality Management System (QMS) in compliance with applicable medical device regulations and standards, including FDA 21 CFR Part 820, ISO... 
    Medical device
    Work at office
    Local area

    Katalyst Healthcares & Life Sciences

    Austin, TX
    2 days ago
  • $89k - $250k

    About Neuralink:We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement...  ...therapy, or physical therapy who also have experience in medical devices and thrive in dynamic clinical environments.You will play... 
    Medical device
    Full time
    Temporary work

    Neuralink

    Austin, TX
    1 day ago
  •  ...industry-focused wealth advisory, digital, audit, tax, consulting, and outsourcing services...  ...such as succession and tax planning.Lead, schedule, supervise, and review tax engagements...  ...at the chance to help others, and you’re ready to join a team of high-performing people.You... 
    Full time
    Flexible hours

    CliftonLarsonAllen

    Austin, TX
    20 hours ago
  •  ...staffing agency is seeking a Quality Systems Specialist in Austin, Texas, to enhance the Quality Management System (QMS) for a leading orthopedic medical device company. Responsibilities include supporting QMS development, conducting compliance assessments, and partnering... 
    Medical device
    Contract work

    Swoon

    Austin, TX
    5 days ago
  •  ...across multiple locations and leading a team of 8+ professionals....  ...the use of SAP, supporting audits and compliance, and partnering...  ...internal controls, audit readiness, and financial compliance for...  ...in manufacturing, preferably medical device or medical equipment ~... 
    Medical device

    Seven Oaks Search Group

    Austin, TX
    23 hours ago
  • $40k

     ...Pursuit Sales Recruiter | Recruiting Elite Sales Talent | Medical Device, Software, & B2B Are you a hungry, independent sales pro...  ...tech hub with significant growth opportunities. If you’re ready to own your territory, create opportunities, and make a real... 
    Medical device
    Full time
    Remote work
    Flexible hours

    Pursuit

    Austin, TX
    3 days ago
  • A leading medical devices company based in Austin, Texas, is seeking a Process Engineer to provide engineering support for manufacturing processes. The role involves improving efficiency, ensuring adherence to operating procedures, and collaborating on new product launches... 
    Medical device

    Artivion, Inc.

    Austin, TX
    4 days ago
  •  ..., TX seeks a Process Engineer for New Product Introduction to design and transfer manufacturing processes into production. You will lead cross-functional teams and drive process improvements on new development projects within Enovis Surgical. The role requires applying... 
    Medical device
    Relocation

    Enovis

    Austin, TX
    4 days ago
  •  ...instruct the abstraction processYou'll lead the execution of feasibility testing to...  ...modifications to software platformsMaintain audit-readiness of documentation through conformance to...  ..., and/or related work experience in a medical device or pharmaceutical industry/companyYou... 
    Medical device
    Work experience placement

    Katalyst HealthCares & Life Sciences

    Austin, TX
    4 days ago
  • A leading medical technology company in Austin, TX is seeking a Senior Product Development Engineer to participate in the design and development...  ...or Biomedical Engineering, and experience in the medical device industry is preferred. The position involves collaboration... 
    Medical device

    Enovis Corp

    Austin, TX
    2 days ago
  • Are you a knowledgeable and driven sales professional, ready to expand your skills into the medical devices field? Our client is searching for a charismatic person with great communication skills to join their team in selling cutting-edge surgical products. A bit about... 
    Medical device
    Permanent employment
    Temporary work
    Work from home

    FMC Talent

    Austin, TX
    3 days ago
  •  ...fast-paced setting. In this position, you will perform preventative maintenance and repair work on a wide variety of medical equipment, some complex devices, systems, and networks. Think you've got what it takes? Qualifications • High school diploma or... 
    Medical device
    Local area
    Weekend work

    Texas Children's Hospital

    Austin, TX
    2 days ago
  • $75k - $100k

     ...safety standards and bridging customer feedback to quality improvement efforts. Candidates should have at least 5 years in the medical device industry and possess strong regulatory knowledge. The estimated salary for this position ranges from $75,000 to $100,000, supplemented... 
    Medical device

    Heartflowinc

    Austin, TX
    5 days ago
  • Innolitics is a remote-first company specializing in medical device software development and FDA regulatory consulting. We work across software engineering and regulatory compliance to deliver robust, traceable systems. As a Medical Device Software Engineer, you will engage... 
    Medical device
    Remote job

    National Asset Mgmt Incorporated

    Austin, TX
    5 days ago
  • Innolitics, a remote-first company specializing in medical device software development and FDA regulatory consulting, seeks a Medical Device Software Engineer to work on cross-functional projects in software development and design assurance. You will help write software... 
    Medical device
    Remote job

    Stryker Corporation

    Austin, TX
    5 days ago
  •  ...manufacturing and testing of medical device IVDs is performed in accordance...  ...authorizes product release Leads the generation/approval of documents...  ...processes Conducts supplier audits (up to 10% travel) Manages...  ...and improvement of the QMS through the creation of processes... 
    Medical device
    Live in

    Nuclein,-LL

    Austin, TX
    2 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Medical Device QMS & BSI Audit Readiness Lead. Be the first to apply!