Staff Supplier Quality Engineer @ ReCor Medical

INACTIVE

Full-Time

Staff Supplier Quality Engineer

Posted on 4/19/2024

ReCor Medical

201-500 employees

Ultrasound renal denervation for blood pressure control

Hardware

Senior

Palo Alto, CA, USA

Required Skills

Management

Requirements

Bachelor's degree in an engineering discipline or equivalent
Minimum of 8 years in Quality Assurance/Quality Engineering role from Medical Device
Regulations experience in any: FDA 21 CFR Part 820, ISO 13485, ISO 14971
In depth knowledge of CAPA and investigational techniques
Working knowledge of design controls, risk management, process validation, and statistical techniques
Strong written and verbal communication skills and ability to collaborate effectively
Proficient in the use of Microsoft Office Suite
COVID-19 vaccination requirements

Responsibilities

Support company goals and objectives, policies, and procedures
Drive CAPA processes including root cause investigation and closure
Identify and prioritize the implementation of proactive quality improvements
Gather and analyze quality system data and metrics around CAPA
Communicate cross functionally on CAPA findings, outcomes
Create, revise and review SOPs and maintain compliance to regulations and ISO requirements
Support change control processes including document control and training
Support the internal audit processes and management review
Support the quality-related aspects of new hire orientation
Act as an administrator of the quality management software
Update and maintain proper Quality System records, reports, and statistics

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 Staff Supplier Quality Engineer is responsible for the support and administration of Quality Systems and ensuring compliance with policies, procedures, and regulatory requirements. The individual will work independently and collaboratively to design and implement quality system solutions.

Responsibilities and Duties

Support company goals and objectives, policies, and procedures
Drive CAPA processes including root cause investigation and closure
Identify and prioritize the implementation of proactive quality improvements
Gather and analyze quality system data and metrics around CAPA
Communicate cross functionally on CAPA findings, outcomes
Create, revise and review SOPs and maintain compliance to regulations and ISO requirements
Support change control processes including document control and training
Support the internal audit processes and management review
Support the quality-related aspects of new hire orientation
Act as an administrator of the quality management software
Update and maintain proper Quality System records, reports, and statistics

Requirements

Bachelor’s degree in an engineering discipline or equivalent
Minimum of 8 years in Quality Assurance/Quality Engineering role from Medical Device
Regulations experience in any: FDA 21 CFR Part 820, ISO 13485, ISO 14971
In depth knowledge of CAPA and investigational techniques
Working knowledge of design controls, risk management, process validation, and statistical techniques.
Strong written and verbal communication skills and ability to collaborate effectively
Proficient in the use of Microsoft Office Suite

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 not discriminate 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.

ReCor Medical Applicant Privacy Policy (linked)

ReCor Medical

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ReCor Medical develops the Paradise™ Ultrasound Renal Denervation (uRDN) System, employing ultrasound energy delivered by a balloon catheter to target overactive renal nerves. This minimally invasive procedure provides a potential reduction in hypertension and medication dependence. As a frontrunner in renal denervation technology, this company offers a dynamic work environment driven by a commitment to improving patient outcomes and advancing medical technology. Employees at ReCor Medical have the unique opportunity to contribute to pioneering healthcare solutions in a collaborative and supportive atmosphere.

Company Stage

Series D

Total Funding

$37.9M

Headquarters

Palo Alto, California

Founded

2009

Growth & Insights

Headcount

6 month growth

↑ 12%

1 year growth

↑ 57%

2 year growth

↑ 95%

INACTIVE