Senior Quality Compliance Specialist

Vor 3 Tagen

Aubonne, Schweiz Intuitive Vollzeit

Company Description

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 a pioneer and market leader in 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 Quality Compliance Sr Specialist is responsible for initiating, coordinating and leading cross functional teams in implementation of process and tool improvement projects in response to new regulations, non-conformances or simplification needs. He/she aims at improving efficiency while promoting best practices, improving compliance, and striving to mitigate risks.

Roles and Responsibilities:

Drive continuous improvement efforts by identifying opportunities for process or tool optimization Analyze new regulations, audit findings or non-conformances, and collaborate with various departments to integrate quality compliance requirements into business and quality management system processes. Develop and implement project management strategies for quality compliance initiatives, ensuring timely and successful execution of projects and providing insights and recommendations to senior management. Provides technical and business input to the European quality function. Serves as a subject matter expert on quality compliance regulations and best practices, partnering with local, corporate and global process owners. Support and execute as necessary, the:Deployment of quality compliance classroom training to local and/or corporate members,Quality Management System activities such as CAPA, Field Safety Corrective Actions, documentation, management review and internal & external audits as needed. Control of European service providersRegulatory Surveillance Other regulatory tasks and projects may be assigned as necessary. Travel: up to 20%.

Qualifications

Required Knowledge, Skills, and Experience:

At least 5+ years of significant experience in quality assurance or regulatory affairs for medical devices according to EU regulations. A Bachelors or Master's degree in engineering, medical technology or similar preferred (or equivalent work experience in similar function). In depth knowledge of medical device regulations, requirements, and standards, such as ISO 13485, ISO14971, European Medical Device Regulation (2017/745/EU), Swiss Medical Devices Ordinance MedDO SRT Ability to work in a fast-paced environment and handle multiple projects simultaneously6-sigmas green or black belt or PMP certification preferred Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices.  Demonstrated organizational and planning skills, including action oriented, focused urgency, and driving for results. Ability to create visualization and high-level models that can be used in future analysis to extend and mature the business capabilities. Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism in an international environment Fluent in written and spoken English. Orientation for work result details, with emphasis on accuracy and completeness. General computer literacy (Microsoft Office, etc.).Knowledge of Trackwise, SAP, Agile preferred

Additional Information

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

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