Quality Engineer - Riverdale Park, United States - Medcura, Inc.

Medcura, Inc. Riverdale Park, United States

3 weeks ago

Description

Medcura, Inc.

is an innovative medical device company dedicated to advancing wound care solutions that improve patient outcomes and reduce healthcare costs.

Leveraging rapid-acting, plant-based hemostatic agents with natural biopolymers, Medcura's products address a broad spectrum of bleeding scenarios, from surgical applications to everyday wounds.

At the heart of its mission, Medcura focuses on enhancing patient care through technology and innovation, making it a leader in the development of effective, safe, and fast-acting wound care management solutions.

Joining the Medcura team means being part of an organization committed to making a significant impact in healthcare and patients' lives worldwide.

Under the direct supervision of the Vice President of Quality, the Quality Professional works with cross functional teams to execute direction for the company's Quality compliance requirements on new and existing devices.

This position is responsible for the day-to-day execution of all Quality System requirements to stay CFR compliant.

Responsibilities

Support the development of the Company's quality objectives and work with the company employees to ensure CFR compliance
Participate in regulatory and quality audits of manufacturing partners, suppliers, and vendors as required to maintain ISO/QSR compliance
Collaborate with internal and external partners e.g., laboratories, manufacturers, and packagers, to provide medical devices that meet quality requirements for new and existing products
Work with product development and operations to design and produce labeling, work instructions, test methods, and instructional and promotional materials that comply with quality requirements
Perform administrative activities associated with the department.

This will include DHR review, NCR and CAPA generation, processing, creation of quality records, risk assessment, ownership of all document control workflows, and support Management Review.

Analyzes process non-conformances and implements comprehensive corrective and preventive action plans
Support the quality system maintenance per all applicable medical device regulations, including QSR, ISO13485, MDSAP, and other standards
May be the primary or sole contributor to a quality specialization (i.e., Validation, Quality Control, Document Control, etc.)
May train and/or direct Quality Specialists or Technicians
Provide training in current industry quality practices. Leverages training and participation in professional quality organizations and conferences to disseminate to Medcura employees

Medcura is a startup entrepreneurial environment, and each employee may be asked to assist in work in areas outside of their usual duties.

Requirements

Four-year degree in engineering or related technical degree. Minimum four years of relevant work experience in the medical device field or related industry.
Demonstrates competencies and ability to support Medcura corporate objectives
Experience in process improvement engineering or product/process improvement areas is preferred
Experience in Quality function or responsibility for ownership of quality system elements within the role(s) is preferred
Working knowledge and understanding of QSR, ISO , FDA and EU MDR and other medical device industry quality requirements. Must be able to understand and apply regulated principles in work experience
American Society of Quality (ASQ) certification (CSQE, CQE, CQA, etc.) is a plus/preferred
Ability to follow instructions in performing repetitive tasks. Attentiveness in performing tasks
Ability to work as a team member in manufacturing and quality custom polymer-based gels
Excellent verbal and written communication skills
Collaborative individual with strong people skills, management, and leadership skills
Strong leadership, excellent organizational skills, and a good blend of discipline and creativity
Solid analytical skills and the ability to solve problems quickly
Knowledge of chemical processing and batch production
Commitment to Medcura with the ability to function within a start-up environment
Skilled in Microsoft Office (Word, Excel, PowerPoint, and Outlook)
Understanding of FDA requirements and ISO 13485

#J-18808-Ljbffr

Quality Engineer

3 weeks ago

Phoenix Innovations Melvin, United States

Job ID: 1491 · General Job Description: · Quality planning for new production processes within the framework of APQP using tools such as FMEA, Control Plan, Inspection Instructions, etc. · Selection of suitable inspection and measurement methods as well as corresponding inspectio ...
Quality engineer

3 weeks ago

Titan Ventures Glassmanor, United States

We are looking for a dedicated Quality Engineer (m/f/d) to take responsibility for the conception and implementation of all quality measures at Glassmanor. In this position, you will play a key role in the continuous improvement of quality, processes, and productivity. · Responsi ...
Quality Engineer

3 weeks ago

Peacefestival Riverdale Park, United States

Opportunities for · Quality Engineer · in · Riverdale Park, MD · Remote positions only · Search completed. Found 0 matching records. · Opportunities for · Quality Engineer · in · Riverdale Park, MD · Remote positions only · Search completed. Found 0 matching records. · Pr ...
Quality Engineer

3 weeks ago

Medcura Riverdale Park, United States

Job Description · Job Description · Medcura, Inc. is an innovative medical device company dedicated to advancing wound care solutions that improve patient outcomes and reduce healthcare costs. Leveraging rapid-acting, plant-based hemostatic agents with natural biopolymers, Medc ...
Quality Engineer

2 weeks ago

Medcura Riverdale Park, United States

Job Description · Job DescriptionMedcura, Inc. is an innovative medical device company dedicated to advancing wound care solutions that improve patient outcomes and reduce healthcare costs. Leveraging rapid-acting, plant-based hemostatic agents with natural biopolymers, Medcura's ...
Quality Engineer

3 weeks ago

BlueHorizon Solutions Glen, United States

Are you dreaming of exciting projects in leading high-tech companies? Are you looking for new challenges in fields such as mechanical engineering, vehicle technology, or alternative energies? Join us in developing world-renowned "Made in Germany" solutions that shape the innovati ...
Quality Engineer

3 weeks ago

Talentry Germantown, United States

Quality Engineer · Direct Hire. 75-80k · Germantown WI · Our client is seeking a detail-oriented and experienced Quality Engineer to maintain and enhance product quality standards. · Responsibilities: · Develop and implement quality control procedures aligned with regulatory stan ...
Sr Principal Quality Engineer

1 day ago

Northrop Grumman Baltimore, United States Full time

Requisition ID: R · Category: Engineering · Location: Baltimore, Maryland, United States of America · Clearance Type: Secret · Telecommute: No- Teleworking not available for this position · Shift: 1st Shift (United States of America) · Travel Required: Yes, 10% of the Time · Pos ...
Electrical engineer in quality assurance

5 days ago

Crimson Technologies Rockville, United States

Rockville Electrical Engineer in Quality Assurance (m/f/d) · With room for your own ideas, modern working methods, a respectful environment, and a sustainable company culture, we are currently seeking an Electrical Engineer in Quality Assurance (m/f/d) to join our team at the ear ...
Software Quality Assurance Engineer

11 hours ago

University of Maryland College Park, United States

Posting Details · Posting Details · Position Number: · Title: · Faculty Assistant · Functional Title: · Software Quality Assurance Engineer · Category Status: · 15-Fac.Non-Tenured,Continuing Con · Applicant Search Category: · Faculty · University Authorized FTE: · 100 · Un ...
Principal Quality Engineer

3 weeks ago

Axient Greenbelt, United States

**Check out this NEW Opportunity with Axient** · Axient seeks an experienced Sr. Quality Engineer to provide quality assurance oversight support on a Goddard Space Flight Center (GSFC) spacecraft being manufactured at GSFC. The chosen candidate will work assuring the project is ...
Principal Quality Engineer

3 weeks ago

Axient, LLC Greenbelt, United States

Axient -: · SPACE · Overview: · Axient seeks an experienced Sr. Quality Engineer to provide quality assurance oversight support on a Goddard Space Flight Center (GSFC) spacecraft being manufactured at GSFC. The chosen candidate will work assuring the project is in compliance w ...
Principal Quality Engineer

1 week ago

Axient Greenbelt, United States

Check out this NEW Opportunity with Axient · Axient seeks an experienced Sr. Quality Engineer to provide quality assurance oversight support on a Goddard Space Flight Center (GSFC) spacecraft being manufactured at GSFC. The chosen candidate will work assuring the project is in co ...
Principal Quality Engineer

3 weeks ago

Axient Greenbelt, United States

Axient - · SPACE · Check out this NEW Opportunity with Axient · Axient seeks an experienced Sr. Quality Engineer to provide quality assurance oversight support on a Goddard Space Flight Center (GSFC) spacecraft being manufactured at GSFC. The chosen candidate will work assuring t ...
Principal Quality Engineer

3 weeks ago

Axient, LLC Greenbelt, United States

Check out this NEW Opportunity with Axient: · Axient seeks an experienced Sr. Quality Engineer to provide quality assurance oversight support on a Goddard Space Flight Center (GSFC) spacecraft being manufactured at GSFC. The chosen candidate will work assuring the project is in ...
Principal Quality Engineer

1 week ago

Axient Greenbelt, United States

Check out this NEW Opportunity with Axient · Axient seeks an experienced Sr. Quality Engineer to provide quality assurance oversight support on a Goddard Space Flight Center (GSFC) spacecraft being manufactured at GSFC. The chosen candidate will work assuring the project is in co ...
Principal Quality Engineer

1 week ago

Axient, LLC Greenbelt, United States

Axient -: · SPACE · Overview: · Axient seeks an experienced Sr. Quality Engineer to provide quality assurance oversight support on a Goddard Space Flight Center (GSFC) spacecraft being manufactured at GSFC. The chosen candidate will work assuring the project is in compliance wit ...
Principal Quality Engineer

3 weeks ago

Axient, LLC Greenbelt, United States

Axient -: · SPACE · Check out this NEW Opportunity with Axient: · Axient seeks an experienced Sr. Quality Engineer to provide quality assurance oversight support on a Goddard Space Flight Center (GSFC) spacecraft being manufactured at GSFC. The chosen candidate will work assur ...
Principal Quality Engineer

3 weeks ago

Axient Greenbelt, United States

**Axient -** · SPACE · **Overview** · Axient seeks an experienced Sr. Quality Engineer to provide quality assurance oversight support on a Goddard Space Flight Center (GSFC) spacecraft being manufactured at GSFC. The chosen candidate will work assuring the project is in compli ...
Sr Principal Quality Supplier Engineer

1 day ago

Northrop Grumman Baltimore, United States Full time

Requisition ID: R · Category: Engineering · Location: Baltimore, Maryland, United States of America · Clearance Type: Secret · Telecommute: Yes-May consider hybrid teleworking for this position · Shift: 1st Shift (United States of America) · Travel Required: Yes, 10% of the Time ...