What are the responsibilities and job description for the Quality Engineer II position at Endo-Therapeutics, Inc.?
Job Description
RESPONSIBILITIES:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Occasional travel may be required.
Company Description
Endo-Therapeutics, Inc. is a medical device manufacturing company that takes great pride in our innovative products, exceptional quality, and, most importantly, our unique company culture. At Endo-Therapeutics, we firmly believe that a diverse and inclusive environment fosters creativity, collaboration, and excellence, enabling us to deliver cutting-edge solutions to meet the evolving needs of the healthcare industry.
Our commitment to creating a great culture of inclusiveness sets us apart. We believe that diverse perspectives and backgrounds fuel innovation and drive our success. We celebrate individuality and actively promote an environment where every employee feels valued, respected, and empowered to contribute their unique talents and ideas.
In addition to our commitment to inclusivity, we pride ourselves on our relentless pursuit of excellence in everything we do. We have assembled a highly skilled and passionate team of professionals who are driven by a shared dedication to improving patient outcomes. Through continuous innovation and rigorous quality standards, we ensure that our medical devices meet the highest industry standards and deliver exceptional performance in the hands of healthcare professionals.
As an organization, we embrace a collaborative approach that encourages open communication and teamwork. We foster an environment where ideas are shared, challenges are overcome together, and everyone is empowered to contribute their expertise. This collective effort allows us to develop comprehensive solutions that address the complex and evolving needs of healthcare providers and patients alike.
We invite you to partner with Endo-Therapeutics, Inc. and experience firsthand our commitment to inclusiveness, innovation, and excellence. Together, we can drive advancements in medical device manufacturing, improve patient care, and make a positive impact on the healthcare industry.
Endo-Therapeutics, Inc. is a medical device manufacturing company that takes great pride in our innovative products, exceptional quality, and, most importantly, our unique company culture. At Endo-Therapeutics, we firmly believe that a diverse and inclusive environment fosters creativity, collaboration, and excellence, enabling us to deliver cutting-edge solutions to meet the evolving needs of the healthcare industry. Our commitment to creating a great culture of inclusiveness sets us apart. We believe that diverse perspectives and backgrounds fuel innovation and drive our success. We celebrate individuality and actively promote an environment where every employee feels valued, respected, and empowered to contribute their unique talents and ideas. In addition to our commitment to inclusivity, we pride ourselves on our relentless pursuit of excellence in everything we do. We have assembled a highly skilled and passionate team of professionals who are driven by a shared dedication to improving patient outcomes. Through continuous innovation and rigorous quality standards, we ensure that our medical devices meet the highest industry standards and deliver exceptional performance in the hands of healthcare professionals. As an organization, we embrace a collaborative approach that encourages open communication and teamwork. We foster an environment where ideas are shared, challenges are overcome together, and everyone is empowered to contribute their expertise. This collective effort allows us to develop comprehensive solutions that address the complex and evolving needs of healthcare providers and patients alike. We invite you to partner with Endo-Therapeutics, Inc. and experience firsthand our commitment to inclusiveness, innovation, and excellence. Together, we can drive advancements in medical device manufacturing, improve patient care, and make a positive impact on the healthcare industry.
RESPONSIBILITIES:
- Support and maintain the Quality Management System (QMS) through the application of quality, regulatory, and engineering principles to ensure products are safe and effective.
- Develop, implement, and maintain quality procedures to ensure product quality.
- Collaborate with cross-functional teams and Sustaining Manufacturing Engineers, to perform nonconformance investigations, support and review FMEAs and risk analyses, review test data and report, change orders, etc., for product quality issues.
- Ensures nonconforming material and finished goods are quarantined, and dispositions NCRs in a timely manner.
- Initiate, facilitate, and track Correction and Preventive Actions.
- Provide technical support and guidance for verifications and validations, including IQ/OQ/PQs.
- Participate in Material Review Board (MRB) activities.
- Maintain and present Quality Metrics/Trend Reporting.
- Perform and support internal and external audits.
- Use statistical methods to identify trends, root causes, and areas for improvement.
- Participates in continuous improvements to ensure that products and services meet or exceed customer requirements.
- Possess a strong technical/scientific background, strong writing skills, and the ability to make sound decisions, as necessary, to facilitate Production’s needs while maintaining adherence to internal requirements, as well as Federal, State, and International Regulations (i.e., ISO, FDA, etc.).
- Provide technical quality guidance to cross-functional teams related to quality standards and internal procedures.
- Provide training to personnel on Quality System initiatives.
- Other duties as assigned.
- Minimum of three (3) years’ experience in the Medical Device industry as a quality engineer, or in a similar role or industry.
- Demonstrated familiarity using Quality tools and methodologies (e.g., Root Cause Analysis, CAPA, FMEA, Validation, Statistical Analysis, Six Sigma, etc.).
- Strong analytical and problem-solving skills.
- Detailed oriented; excellent writing, communication, and interpersonal skills are a must.
- Bachelor’s degree in Engineering, or related technical field.
- Six-Sigma Black and/or Green Belt certification, a plus.
- ASQ CQA certification, a plus.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Work performed in an office and factory settings.
- Ability to manage multiple priorities.
- Regularly required to sit, stand, and move around facilities.
Occasional travel may be required.
Company Description
Endo-Therapeutics, Inc. is a medical device manufacturing company that takes great pride in our innovative products, exceptional quality, and, most importantly, our unique company culture. At Endo-Therapeutics, we firmly believe that a diverse and inclusive environment fosters creativity, collaboration, and excellence, enabling us to deliver cutting-edge solutions to meet the evolving needs of the healthcare industry.
Our commitment to creating a great culture of inclusiveness sets us apart. We believe that diverse perspectives and backgrounds fuel innovation and drive our success. We celebrate individuality and actively promote an environment where every employee feels valued, respected, and empowered to contribute their unique talents and ideas.
In addition to our commitment to inclusivity, we pride ourselves on our relentless pursuit of excellence in everything we do. We have assembled a highly skilled and passionate team of professionals who are driven by a shared dedication to improving patient outcomes. Through continuous innovation and rigorous quality standards, we ensure that our medical devices meet the highest industry standards and deliver exceptional performance in the hands of healthcare professionals.
As an organization, we embrace a collaborative approach that encourages open communication and teamwork. We foster an environment where ideas are shared, challenges are overcome together, and everyone is empowered to contribute their expertise. This collective effort allows us to develop comprehensive solutions that address the complex and evolving needs of healthcare providers and patients alike.
We invite you to partner with Endo-Therapeutics, Inc. and experience firsthand our commitment to inclusiveness, innovation, and excellence. Together, we can drive advancements in medical device manufacturing, improve patient care, and make a positive impact on the healthcare industry.
Endo-Therapeutics, Inc. is a medical device manufacturing company that takes great pride in our innovative products, exceptional quality, and, most importantly, our unique company culture. At Endo-Therapeutics, we firmly believe that a diverse and inclusive environment fosters creativity, collaboration, and excellence, enabling us to deliver cutting-edge solutions to meet the evolving needs of the healthcare industry. Our commitment to creating a great culture of inclusiveness sets us apart. We believe that diverse perspectives and backgrounds fuel innovation and drive our success. We celebrate individuality and actively promote an environment where every employee feels valued, respected, and empowered to contribute their unique talents and ideas. In addition to our commitment to inclusivity, we pride ourselves on our relentless pursuit of excellence in everything we do. We have assembled a highly skilled and passionate team of professionals who are driven by a shared dedication to improving patient outcomes. Through continuous innovation and rigorous quality standards, we ensure that our medical devices meet the highest industry standards and deliver exceptional performance in the hands of healthcare professionals. As an organization, we embrace a collaborative approach that encourages open communication and teamwork. We foster an environment where ideas are shared, challenges are overcome together, and everyone is empowered to contribute their expertise. This collective effort allows us to develop comprehensive solutions that address the complex and evolving needs of healthcare providers and patients alike. We invite you to partner with Endo-Therapeutics, Inc. and experience firsthand our commitment to inclusiveness, innovation, and excellence. Together, we can drive advancements in medical device manufacturing, improve patient care, and make a positive impact on the healthcare industry.