Director, Manufacturing & Market Quality

Palo Alto, CA, United States

At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise uRDN System, we’re on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join us on our journey and make a meaningful impact on the lives of people around the globe.

The Director of Manufacturing and Market Quality will be responsible for overseeing all aspects of quality management and ensuring compliance with industry standards and regulations. This is a leadership role that requires strong analytical skills, attention to detail, and the ability to effectively manage quality systems.

This position will interface with cross-functional departments facilitating resolution of events. As a leader, the candidate is expected to effectively lead and mentor.

Responsibilities and Duties In partnership with the Sr VP of Quality & Regulatory, establishes overall short and long-term quality strategy and objectives.

Ensuring, promoting a world-class quality mindset via a robust training and quality system strategy.

Work closely with the various functional leaders to define KPIs, perform analysis and propose corrective action plans and present to the executive leadership team.

Develop and implement quality control processes and procedures to ensure product integrity and customer satisfaction.

Conduct quality audits and inspections to identify areas for improvement.

Collaborate with cross-functional teams to develop and implement corrective actions.

Oversee the development and maintenance of quality systems, including document control, change control, and deviation management.

Lead and mentor a team of quality professionals.

Manage projects related to quality improvement initiatives.

Utilize statistical analysis tools to analyze data and identify trends.

Collaborate with suppliers and vendors to ensure quality standards are met

Implement HACCP (Hazard Analysis Critical Control Point) principles to ensure food safety

Collaborate with cross-functional departments to drive continuous improvement initiatives.

Influence policymaking and conduct internal audits of systems and processes in all functional areas.

Develops, implements and enforces QC testing procedures and policies consistent with global systems, company policies and regulatory requirements.

Responsible for determining manufacturing best practices through collaboration with other corporate level functions, and industry standards.

Defines and implements systems and metrics (KPIs).

Performs compliance monitoring of all areas of quality management systems, including trending of failures and evaluating closure rate/efficiency of corrective actions.

Interfaces with other departments and partners to ensure implementation of good compliance practices.

Prepares for and leads third party regulatory and supplier audits and inspections.

Establishes, monitors, and reports key process indicators and drive actions as needed.

Develops and manages trending programs.

Establishes and manages training programs focused on cGMP, QMS, defect awareness, Quality at the Source, and other training programs that promote quality awareness and understanding.

Executes responses to field actions and coordinates global response with Quality leadership and associated corporate functions.

Creates bench-marking opportunities to seek best practices with the intention to improve internal processes.

Ensures continued professional development of staff through training and functional interactions with various operating groups throughout the supply chain.

Serves on internal project teams to shape the direction and influence actions based on extensive knowledge of regulatory requirements, industry standards, company strategy and laboratory technical implications.

Exerts influence in the development of objectives and long-range goals of the organization.

Uses scientific expertise to provide guidance on troubleshooting, investigations and problem resolution.

Supports the ongoing development and implementation of a Corporate Quality System.

Develop and implement a comprehensive strategy to support the manufacturing, testing, and release of products in accordance with regulations and standards.

Manages projects and/or cross functional teams as needed.

Oversee and manage all aspects of the Quality Management System (QMS) to ensure compliance with GMP, GLP, and other applicable guidelines.

Requirements Bachelor's degree in an engineering or scientific-related field

10+ years of experience in a global Quality function

5+ years of experience in a managerial position is preferred.

Working knowledge of appropriate global regulations, requirements, and standards such as 21CFR Parts 803, 806, and 820, ISO 13485, and ISO 14971.

Demonstrated ability to collaborate with the business and effectively interact with and influence employees, and managers on all levels.

Demonstrated expertise in problem solving tools and techniques.

$210,000 - $234,000 a year Level and Title is commensurate with experience, skills, education, and training. COVID-19 vaccination requirements

At Recor Medical, we care, we collaborate, we challenge, and we create. Pursuant to these core values, we are focused on the health and safety of our employees, as well as the teamwork essential for innovation of our pioneering technology.COVID-19 vaccines will be required for all ReCor US office employees effective June 10, 2021, as well as all new US office employees joining our company.Fully vaccinated persons are those who are >=14 days post-completion of the primary series of an FDA-authorized COVID-19 vaccine.

Equal Employment Opportunity

At Recor Medical, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do notdiscriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

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