- Establish programs, guidelines and procedures related to areas of responsibility to include but not limited to Quality systems including Change Control, Data and Document Management and Records Management and Compliance Training
- Working with Learning Management staff to develop and deploy an optimized compliance training program and monitoring.
- Working with cross functional leadership to implement best practices for change control documents and records management.
- Working with Heads of RAQA APAC and RAQA EMEA to ensure international quality systems are compliant and effective for local, regional and corporate business needs as well as regional regulatory requirements.
- Responsible for assisting in management of regulatory inspections/external audits and related compliance activities. Support internal audits execution and related findings.
- Working with Head of Audit, help define programs that ensure the verification and monitoring of the effectiveness of the quality system and its compliance to applicable regulations and standards.
- Working with Head of RAQA Operational Excellence, help define the Quality Systems improvement strategy that includes responsibilities for development, implementation and the continuous improvement of ISI quality system(s).
- Provide training and consulting to internal customers on quality system regulatory compliance.
- Partner across the company to drive standardization of Quality Systems.
- Establish programs to effectively monitor and assess the global quality system through key performance indicators, metrics and scorecards.
- Work to ensure the timely identification, escalation and corrective actions resulting from Management Review and Quality System reviews.
- A minimum of 12 years' experience in a Medical device setting, with a minimum of 8 years in a quality assurance or compliance management role is required OR a Masters' degree and a minimum of 10 years' experience in a Medical device setting, with a minimum of 8 years in a quality assurance or compliance management role is preferred.
- Demonstrated leadership to ensure alignment of priorities and program delivery is required.
- Demonstrated strong interpersonal skills and a passion for developing teams and people to their highest potential is required.
- Demonstrated ability to lead through influence and expertly communicate program updates in both oral and written formats in a cross-functional matrix organization is required.
- Demonstrated knowledge of Risk Management practices, Corrective and Preventative Actions and regulatory requirements such as FDA QSR's, ISO 13485, MDSAP, MDR, MDD is required.
- Demonstrated experience in managing external regulatory body audits.
- Demonstrated leadership of CAPA Programs Familiarity with CFR 210/211 regulations A working knowledge of project management tools and techniques is required.
- A minimum of a Bachelor's Degree is required.
- An Engineering or Science degree is highly preferred.
- Experience implementing medical device and non-medical device quality management systems (QMS) preferred.
- Experience with eQMS platform implementation preferred.
- Six Sigma, RAC, ASQ certification is preferred.
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Director Quality Systems - Sunnyvale, United States - Intuitive
Description
Company DescriptionAt 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 Director, Quality Systems will be a key member of the Quality Systems and Compliance leadership team with broad responsibilities. The successful candidate will help to create a quality management infrastructure that is compliant, effective, efficient and agile and that supports a rapidly growing international business model with complex and diverse product lines. S/he will provide quality management oversight for elements of the Intuitive Surgical Quality Management System (QMS), which includes design controls, corrective and preventive action, training, document controls, production and process controls, facilities and equipment controls, and material controls through to GMP for all aspects including identification and escalation of quality system and product issues. Provide strategic guidance regarding the establishment and monitoring of quality metrics for executive review to determine health of QMS and lead the team in continuous improvement and planning for growth activities as needed. S/he will grow, develop and manage team to interface and support all regulatory compliance requirements of the company.
Essential Job Duties
Required Skills and Experience
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
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.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.
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