Global Corporate Auditor (gn)

Intuitive Surgical; Freiburg im Breisgau; Vor Ort; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

Join a pioneering company in robotic-assisted surgery, committed to enhancing minimally invasive care. As a Global Corporate Auditor, you will play a vital role in ensuring compliance with regulatory standards, conducting audits, and supporting quality improvement projects. Collaborate with diverse teams to drive continuous process enhancements and educate employees on quality systems. This role offers a unique opportunity to contribute to groundbreaking healthcare solutions while working in an inclusive environment that values diverse perspectives. If you are passionate about quality assurance and eager to make a meaningful impact, this position is for you.

Qualifikationen

• 2+ years of FDA/ISO 13485 lead auditing experience.
• Strong knowledge of EU-MDR and 21 CFR 820 requirements.
• Experience in quality in the medical device industry.

Aufgaben

• Conduct internal audits across all global sites.
• Support supplier and clinical audits as assigned.
• Train company employees on Quality System Regulations.

Kenntnisse

ISO 9001 Lead Auditor

FDA Regulations

ISO 13485

Quality Assurance

Critical Thinking

Communication Skills

Ausbildung

Bachelor of Science in Technical, Engineering or Science

Tools

Quality Management Systems (QMS)

CAPA Documentation

Jobbeschreibung

At Intuitive, we are united behind our mission : we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As pioneer and leading company in the field of robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare’s hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture—our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real-world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let’s advance the world of minimally invasive care.

Job Description

Primary Function of Position

The Global Corporate Auditor will support the execution of an efficient and effective Quality audit program. They will support the internal, external, supplier and clinical audit programs to ensure compliance to the applicable regulatory requirements and standards. This individual will have a clear understanding of applicable laws and regulations in order to identify and manage the company's risks appropriately. They will use Quality Auditing principles, tools and techniques to support quality systems and processes aligned with the overall Company strategy and mission affecting continuous process improvement. They will ensure effective closure of audit findings, by working with cross functional and varying level of departments / business partners to ensure comprehension, development, and execution of corrective / preventive action and evaluation of effectiveness checks. They will assist with gap assessments including working with functional area owners to close regulatory gaps. They will continually educate the organization on effective compliance systems, processes in alignment with applicable laws and regulations. They will support the quality and regulatory improvement projects and provide insight for long-term strategic QMS improvement.

Roles and Responsibilities :

• Conduct internal audits across all global sites.
• May also coordinate internal audits and provide oversight to external contractors.
• Support supplier and clinical audits as assigned.
• Support external audits or regulatory inspections across global sites
• Complete gap assessment for regulations, regulatory standards, and corporate procedures
• Train company employees on Quality System Regulations and quality system foundational principles
• Work together with strategic partners across global sites to assure compliance with all company procedures and regulatory requirements.
• Support Quality System projects for new and changing regulatory requirements Serves as the lead coach / consultant to educate internal customers on regulatory compliance processes and regulations
• Create, approve, and maintain company quality documents, such as quality procedures, work instructions, and forms
• Support CAPA program as audit findings are an input to the CAPA process.
• Review, approve, provide feedback on CAPA documentation as assigned
• Analyzes quality data and provides compliant, pragmatic guidance to support Regulatory Compliance activities including responses to agency requests for information and analyses to support quality improvement projects.
• Prepare responses to regulatory audit observations.
• Ensure that responses are clear, comprehensive, accurate, and well written to mitigate potential for further regulatory actions.
• Provide data to support; Risk based audit schedule, process analysis, process controls, FDA trending and finding history, and needed process improvements activities
• Support implementation and continuous improvement of the audit programs, auditor qualification programs, and company-wide inspection readiness.
• Support, consult, train, and lead quality improvement projects
• Provide Quality System Consultation Support new site integration activities across global sites
• Assist in the development and reporting of Quality System Metrics and KPIs

Qualifications

Required Knowledge, Skills, and Experience :

• ISO certified lead auditor (ISO 9001, ISO 13485 and / or ISO 14155 or ASQ CQA)
• Minimum 2+ years of FDA / ISO 13485 lead auditing experience
• Minimum 5 years of experience in quality in the medical device industry
• Previous experience conducting internal audit is must
• Experience conducting supplier and clinical site audit is a plus
• Quality Engineer, Software Quality and Validation experience is a plus
• Strong knowledge of EU-MDR, ISO 13485 : 2016; Medical Device Single Audit (MDSAP), and 21 CFR 820 requirements, , Health Canada, and other international regulatory requirements
• Previous experience participating in notified body and FDA inspections
• Familiarity with GMPs related to Combination and Drug Products
• Ability to work on virtual teams, remote management; self-directed
• Ability to be a team player and a partner to the cross- functions teams; be part of the solution and demonstrate ability to use risk-based judgment.
• Critical thinking skills and a passion to work in a fast-paced industry with complex / cutting edge technology
• Strong organizational, written and verbal communication skills, remote working apps and the proven ability to prioritize tasks effectively in a deadline-driven environment

Required Education and Training

• Minimum Bachelor of Science degree in Technical, Engineering or Science related field.

Additional Information