Teleflex
Quality Assurance Engineer
Teleflex, Mansfield, Massachusetts, us, 02048
Expected Travel : Up to 10%
Requisition ID : 11178
About Teleflex Incorporated
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rsch™, UroLift™ and Weck™ - trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.
OEM -
Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
Position Summary
The Quality Assurance Engineer shall support the facility and departments in the development, implementation and maintenance of the quality system. This includes supporting both the quality and manufacturing departments with regards to the applicable QSRs and ISO standards.
Principal Responsibilities
1. Drive continuous improvement initiatives focused on enhancing product quality and reliability.2. Ensure manufacturing processes comply with regulatory and quality system standards, including FDA, ISO 13485, and other relevant industry regulations.3. Develop, implement, and maintain process control plans and standard operating procedures (SOPs) to ensure consistent product quality throughout production.4. Collaborate with cross-functional teams, including engineering, supply chain, and production, to identify and resolve quality issues in the manufacturing process.5. Conduct process validation, ensuring that equipment and processes meet predetermined specifications and quality requirements.6. Lead root cause analysis and implement corrective and preventive actions (CAPAs) to address non-conformances and improve process performance.7. Support internal and external audits, ensuring production areas are audit-ready and maintain thorough documentation for compliance.8. Monitor key performance indicators (KPIs) in manufacturing, driving continuous improvement initiatives to enhance process efficiency and product reliability.9. Oversee incoming material inspections and ensure supplier quality meets company standards through supplier audits and corrective actions.
Education / Experience Requirements
Bachelor's Degree in Engineering, Chemistry, Physical Science, or related field is preferred or 3+ years of Quality Assurance experience working in the medical device manufacturing environment (a combination of education and experience will be considered)•Experience in the generation and revision of Standard Operating Procedures (SOPs) for various quality and manufacturing related processes in a medical device environment, preferred.
Specialized Skills / Other Requirements•cGMP, QSR, ISO 13485 knowledge base required.•Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint. Ability in data-base development, statistical software and analysis, simulation, word processing for report generation, etc.•ASQ Certification (CQA, CQIA, CQE, Green Belt) preferred#LI-LM1
At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.
Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.
Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.© 2024 Teleflex Incorporated. All rights reserved.
Requisition ID : 11178
About Teleflex Incorporated
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rsch™, UroLift™ and Weck™ - trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.
OEM -
Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
Position Summary
The Quality Assurance Engineer shall support the facility and departments in the development, implementation and maintenance of the quality system. This includes supporting both the quality and manufacturing departments with regards to the applicable QSRs and ISO standards.
Principal Responsibilities
1. Drive continuous improvement initiatives focused on enhancing product quality and reliability.2. Ensure manufacturing processes comply with regulatory and quality system standards, including FDA, ISO 13485, and other relevant industry regulations.3. Develop, implement, and maintain process control plans and standard operating procedures (SOPs) to ensure consistent product quality throughout production.4. Collaborate with cross-functional teams, including engineering, supply chain, and production, to identify and resolve quality issues in the manufacturing process.5. Conduct process validation, ensuring that equipment and processes meet predetermined specifications and quality requirements.6. Lead root cause analysis and implement corrective and preventive actions (CAPAs) to address non-conformances and improve process performance.7. Support internal and external audits, ensuring production areas are audit-ready and maintain thorough documentation for compliance.8. Monitor key performance indicators (KPIs) in manufacturing, driving continuous improvement initiatives to enhance process efficiency and product reliability.9. Oversee incoming material inspections and ensure supplier quality meets company standards through supplier audits and corrective actions.
Education / Experience Requirements
Bachelor's Degree in Engineering, Chemistry, Physical Science, or related field is preferred or 3+ years of Quality Assurance experience working in the medical device manufacturing environment (a combination of education and experience will be considered)•Experience in the generation and revision of Standard Operating Procedures (SOPs) for various quality and manufacturing related processes in a medical device environment, preferred.
Specialized Skills / Other Requirements•cGMP, QSR, ISO 13485 knowledge base required.•Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint. Ability in data-base development, statistical software and analysis, simulation, word processing for report generation, etc.•ASQ Certification (CQA, CQIA, CQE, Green Belt) preferred#LI-LM1
At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.
Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.
Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.© 2024 Teleflex Incorporated. All rights reserved.