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
- 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 deviceImmediate start
$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 deviceFull timeTemporary workH1b$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 devicePermanent employmentContract workH1bLocal areaRemote workVisa sponsorshipWork visaRelocation package- ...& 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 deviceRemote work
- 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
- ...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 deviceFull timeH1bWork at office
$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 deviceWork at officeLocal areaShift work$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 deviceRemote workVisa sponsorship$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 deviceFlexible hours- ...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
$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- ...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
- ...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 deviceFlexible hours
- ...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
- ...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 deviceWork at officeLocal area
$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 deviceFull timeTemporary work- ...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 timeFlexible hours
- ...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 deviceContract work
- ...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
$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 deviceFull timeRemote workFlexible hours- 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
- ..., 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 deviceRelocation
- ...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 deviceWork experience placement
- 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
- 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 devicePermanent employmentTemporary workWork from home
- ...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 deviceLocal areaWeekend work
$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- 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 deviceRemote job
- 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 deviceRemote job
- ...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 deviceLive in
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