-
Quality Engineer
1 week ago
Eclipse Innovations Raleigh, United StatesRequisition id: 19015 · Responsibilities: · Supplier management and development · Introduction of new products and product/process changes until series maturity · Conducting supplier and process audits · Handling complaints and tracking improvement measures · Creation and adaptat ...
-
Quality Engineer
1 week ago
Accu-Fab Manufacturing Raleigh, United StatesTITLE: QUALITY ENGINEER · ROLE LOCATION: Raleigh, NC · REPORTS TO: Quality Manager · ABOUT ACCU-FAB · Accu-Fab is a leading precision metal fabrication manufacturing business specializing in producing high-quality metal components and assemblies for various industries. Our state- ...
-
Quality Engineer
1 week ago
Merz Pharmaceuticals LLC Raleigh, United StatesThe Quality Engineer, is responsible for providing support of R&D Quality activities as related to Medical Devices including the completion of day-to-day R&D Quality project activities. Additionally, this position will operate as a liaison among the various R&D functions and the ...
-
Quality Engineer
6 days ago
Merz North America Raleigh, United StatesThe Quality Engineer, is responsible for providing support of R&D Quality activities as related to Medical Devices including the completion of day-to-day R&D Quality project activities. Additionally, this position will operate as a liaison among the various R&D functions and the ...
-
Quality Engineer
3 days ago
Accu-Fab Manufacturing Raleigh, United StatesTITLE: QUALITY ENGINEER · ROLE LOCATION: Raleigh, NC · REPORTS TO: Quality Manager · Want to apply Read all the information about this position below, then hit the apply button. · ABOUT ACCU-FAB · Accu-Fab is a leading precision metal fabrication manufacturing business speci ...
-
Quality Engineer
1 week ago
Accu-Fab Manufacturing Raleigh, United StatesTITLE: QUALITY ENGINEER · ROLE LOCATION: Raleigh, NC · REPORTS TO: Quality Manager · ABOUT ACCU-FAB · Accu-Fab is a leading precision metal fabrication manufacturing business specializing in producing high-quality metal components and assemblies for various industries. Our st ...
-
Quality Engineer
5 days ago
Merz North America Raleigh, United StatesThe Quality Engineer, is responsible for providing support of R&D Quality activities as related to Medical Devices including the completion of day-to-day R&D Quality project activities. Additionally, this position will operate as a liaison among the various R&D functions and the ...
-
Quality Engineer
4 days ago
Merz North America Raleigh, United StatesThe Quality Engineer, is responsible for providing support of R&D Quality activities as related to Medical Devices including the completion of day-to-day R&D Quality project activities. Additionally, this position will operate as a liaison among the various R&D functions and the ...
-
Quality Engineer
1 week ago
Alliance Industries, Inc. Raleigh, United StatesAnduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business model of the 21st century's most innovative companies to the defense industry, Anduri ...
-
Quality Engineering
3 weeks ago
PwC Raleigh, United States Full timeA career in Software and Product Innovation will provide you with the opportunity to deliver innovative solutions that are valuable, usable, and aligned with accomplishing the company's mission. We help build software and design data platforms, manage large volumes of client data ...
-
Senior Quality Engineer
6 days ago
Connect Life Science Raleigh, United StatesJob Title: Senior Quality Engineer · Location: · Raleigh, North Carolina · Salary: $105,000 - $110,000 · Company Description: · Our client are a leading pharmaceutical manufacturing company dedicated to producing high-quality medications that improve patient outcomes worldwide ...
-
Quality Systems Engineer
1 week ago
Deere Raleigh, United StatesAdvanced Options · 188 open jobs. · Match scores are indicators of potential fit and not a promise of any hiring activities. · Jobs will be labeled when they're a good or great match · Great matches will be shown first in search results · Relevant skills and experience will be l ...
-
supplier quality engineer
1 week ago
DSJ Global Raleigh, United StatesSupplier Quality Engineer · Job Description: Role: · Supplier Quality Engineer · Location: · This is a flexible one- to two-day onsite event in North Carolina's Marion. · Type of Employment: · Full-Time, with 50% travel required and 100% onsite presence. · About the Role: · As ...
-
Quality Engineer II
1 week ago
LER TechForce Raleigh, United StatesQuality Engineer II · Are you looking to work for a company that provides an innovative work environment, and your voice is heard? We have a position for a Quality Engineer II (this is a contract position). · Who we are: · LER TechForce is an industry leader in embedded contro ...
-
Senior Quality Engineer
1 week ago
Connect Life Science Raleigh, United StatesJob Title: Senior Quality Engineer · Location: Raleigh, North Carolina · Salary: $105,000 - $110,000 · Company Description: Our client are a leading pharmaceutical manufacturing company dedicated to producing high-quality medications that improve patient outcomes worldwide. Wi ...
-
Senior Quality Engineer
1 week ago
Asahi Kasei America Raleigh, United StatesThe Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh pers ...
-
Supply Quality Engineer
1 week ago
Trilliant Networks Raleigh, United StatesTrilliant offers a universal communications platform that is at the convergence of the smart grid, smart city, and global Industrial Internet of Things (IIoT) applications. We bring together multi-technology solutions, global capabilities, and mission-critical communications to d ...
-
Senior Quality Engineer
5 days ago
Seneca Resources Raleigh, United StatesPosition: Sr. Quality Engineer · Location: Raleigh, NC – remote-first with quarterly team onsite, must driving distance from Raleigh Terms: Contract thru Apr 2025 with potential to extend/convert · We are looking for a Sr. Quality Engineer/Software Developer in Test to join a ti ...
-
Sr Quality Engineer
6 days ago
Veradigm Raleigh, United StatesWelcome to Veradigm Our Mission is to be the most trusted provider of innovative solutions that empower all stakeholders across the healthcare continuum to deliver world-class outcomes. Our Vision is a Connected Community of Health that spans continents and borders. With the larg ...
-
Sr Quality Engineer
5 days ago
Veradigm Raleigh, United StatesWelcome to Veradigm Our Mission is to be the most trusted provider of innovative solutions that empower all stakeholders across the healthcare continuum to deliver world-class outcomes. Our Vision is a Connected Community of Health that spans continents and borders. With the larg ...
Quality Engineer - Raleigh, United States - Merz North America
Description
The Quality Engineer, is responsible for providing support of R&D Quality activities as related to Medical Devices including the completion of day-to-day R&D Quality project activities.
Essential Duties and ResponsibilitiesR&D Project Teams:
Responsible for supporting Medical Devices Project Teams and attending meeting in a Quality consultancy capacitySupport document reviews and regulatory submissionsEffectively manage project timelines as defined by department, project team, and corporate objectives
Risk Management:
Facilitate and provide input to risk management activities throughout all stages of the device development processManage the risk management plan, risk file and risk report for assigned projects
Human Factors Engineering:
Facilitate and provide input to human factors/usability activities throughout all stages of the device development processManage the human factors engineering/usability plan, Use/misuse error analysis, usability task analysis, facilitate formative and validation protocols and reportDesign & Development:Facilitate and provide input to Medical Device manufacturing and Design & Development activities throughout all stages of the device development process (e.g. general Product Development / Design Control customer input, specification development, verification and validation testing, manufacturing transfer, risk assessment, usability, design change control).
Provide input and review Design & Development documentation for assigned projectsAudits:
Conduct R&D related audits, both internal and externalSupport R&D vendors/suppliers qualificationsSupport all Merz regulatory authority inspections and certification body audits, as applicableGeneral R&D Support:Support R&D related activities including but not limited to SOP creation and maintenance, NCRs, DCNs, CAPAs, deviations, change requests, archival, corporate, and departmental initiativesR&D
Quality Improvements:
Facilitate and support harmonization initiatives within the R&D groupFacilitate and support projects to improve R&D compliance and operational efficiencies
Quality Intelligence:
Stay informed of the latest updates related to applicable regulations to ensure R&D Quality policies and procedures remain compliantas related to Medical DevicesProvide updates to R&D staff, as applicable
Further Tasks:
Communicate effectively cross-functionally and raise questions/issues to the attention of executive management, as appropriateProvide support to other R&D staff as needed and perform duties and assignments as requiredOther duties as assigned:Additional duties as needed to support the business and overall company objectivesJob Related Qualifications/SkillsProfessional ExperienceRequired:Minimum 2 years relevant Quality/Compliance and medical device development experiencePreferred:Certification(s) - ASQ Certified Quality Manager; Certified Quality Engineer, or Certified Quality AuditorEnergy-Based Device ExperienceKnowledge, Skills and AbilitiesRequired:Proficient in all MS Office applicationsDemonstrated organizational skills, ability to independently prioritize work and detail orientedStrong verbal and written communication skillsAbility to effectively multitask and manage multiple projectsExperience with FDA, European agency regulations, cGMP regulations, and Quality Management software is highly preferredKnowledge of regulatory requirements and standards for a medical device organization (i.e., 21CFR820, ISO 13485, ISO 14971, IEC 62304, ICH guidelines.)
Ability to work effectively in a global, matrix environmentPreferred:
Ability to travel up to 15%EducationRequired:Bachelor's Degree in Engineering or Life/Health SciencesPreferred:Master's DegreeEqual Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
41 CFR c)
