Director of Quality

Newton, MA, United States

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Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

We are currently looking for an ambitious Director of Quality to join our Endovascular Robotics business within Advanced Therapies. We are a global technology leader in robotic-assisted vascular interventions. We believe the combination of endovascular robotics, image guidance and dedicated devices will change the way neurovascular procedures will be done in the future, enabling better outcomes, and enabling our customers to provide better access to care.

As a Director of Quality, you will coordinate all activities involving developing, establishing, and maintaining a quality management system and practices that meet world class compliance standards. You will serve as a multi-functional team leader for quality improvement teams assuring internal and external compliance objectives are achieved and support regulatory and agency inspections/audits with positive results.

In addition, you will ensure performance and quality requirements and standards are upheld across the organization and with outside suppliers. You will interpretate and apply regulations, maintain key processes and documentation to support regulatory filings, and develop and maintain department and project budgets.

You will be responsible for:

* Developing and implementing the internal quality management systems, including tracking, analyzing, reporting and problem solving for ongoing process improvement. Develop, implement, and monitor quality metrics and communicate status and progress.

* Coordinating and serving as the contact with management, manufacturing engineering, R&D, clinical, regulatory, and product management on all issues related to quality assurance and compliance.

* Providing coordination and guidance to cross functional teams to ensure product quality objectives are met.

* Coordinating and serving as the contact with all external contract organizations including key domestic and international vendors, contractors, or service providers, including but not limited to CMO's, CRO's, Labs, consultants, testing facilities, auditors, and/or advisors related to quality aspects of GxP related expectations.

* Ensuring Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, Health Hazard Evaluations, etc.

* Managing the Quality Team with a focus on ensuring operational excellent regarding efficiency, improvement, priorities and strategy.

* Develops systems for monitoring manufacturing quality. Recommends and assists, as necessary, in the implementation of corrective/preventative actions.

* Demonstrates understanding of the audit process including types of audits, planning, preparation, execution, reporting results and follow-up.

* Lead problem-solving teams through root cause investigations and failure analysis to implementation and final verification.

* Develop validation strategies so that all appropriate requirements are being met from planning, protocol definition, leading execution of protocol, analyzing and reporting results and defining procedures and training requirements, completing report, and gaining approval to close.

* Participate in the development and results analysis of validation plans (IQ/OQ/PQ) and test protocols to qualify and validate existing and new product designs and processes. Includes the use of various statistical techniques and quality tools.

* Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.

* Plan and provide support for FDA and other governmental or ISO Notified Body inspections, including pre- and post-inspection support, as requested. Support activities may include actively and directly interacting with inspectors/auditors, obtaining required information, and assisting with corrective action and/or remediation plans, as necessary.

Required skills to have for the success of this role:

* Minimum of 10 years of progressive quality experience; including experience in a QA leadership role in the related field or a combination of equivalent education and relevant experience along with at least 5 years of supervisory/management experience.

* BS in Mechanical Engineering, Biomedical Engineering, Process Engineering, Analytical Chemistry, or related technical discipline. Master's preferred.

* Demonstrated experience in QA oversight and management of products through the lifecycle of medical device product development.

* Experienced QA leadership background with a track record of establishing and maintaining quality systems, practices, and policies in medical device development environments.

* Experience and ability with applying regulatory requirements including CFR, ISO, GMP, and EU MDR .

* Product design control experience of low to medium volume manufacturing of electro-mechanical products highly desirable.

* Apply and instruct others in the use of Quality systems (CAPAs, change control, measurement systems and Analysis (MSA), Statistical Analysis, Control Plans, document management, etc)

* Solid experience in Risk Management for medical devices ISO 14971.

* Facilitates team efforts on quality engineering projects.

* Highly skilled with root cause analysis tools and methods.

* Knowledge of 510(k), PMA, and ongoing submission maintenance requirements.

At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.

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If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.

If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.

As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.

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