- Actively participate in the product development stage gate process. Lead risk analysis activities and FMEAs, and support verification and validation activities. Ensure quality is built into processes as transferred to manufacturing.
- Participates in design reviews, design transfers, and in all aspects of the Design Control process for the new product. Actively participate in and guide all aspects of Design Control and Change Control.
- Fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements.
- Ensure that all work activity is performed in accordance with established internal procedures, and FDA's Quality System Requirements.
- Responsible for timely review and approval of batch records, DHRs and batch release.
- Lead MRB team to ensure timely disposition of planned deviations and nonconforming material.
- Manage and support team with CAPAs and complaint investigations.
- Manage Deviations through their life cycle and review trends for corrective actions.
- Mentor and provide guidance to peers and quality team members on best practices.
- Support activities associated with agents of regulatory bodies as necessary to demonstrate quality system compliance.
- Support certification / recertification activities for US, European and other markets.
- Serve as an Internal Auditor to support the quality internal audit program.
- Develop and establish effective quality plans.
- 6+ years of related Quality Engineering experience with combination or single use devices.
- Bachelor's degree in Chemical Engineering, Industrial Engineering, Process Engineering, Biomedical Engineering, or a Science field.
- Proven proficiency with quality tools and techniques in a manufacturing environment.
- Strong attention to detail.
- Strong written and verbal communication skills.
- Strong problem-solving skills & techniques.
- Well versed with ISO 13485 and FDA QSR standard.
- Experience as an internal or lead auditor a plus.
- Prior experience with MasterControl a plus.
- Up to 10%
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Quality Engineer
5 days ago
Mahle Inc. Oklahoma City, United StatesSelect how often (in days) to receive an alert: · Create Alert · We move the world — together. As an international leading development partner and supplier to the automotive industry, we at MAHLE are passionate about developing innovative solutions for climate-neutral mobility o ...
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Quality Engineer
2 weeks ago
Doncasters Group Oklahoma City, United StatesDid you know that every time you take a flight, drive somewhere or every time you have electricity at the touch of a button, there's a chance that Doncaster's played a part in making that happen? · At Doncasters we have an exciting opportunity for a Quality Engineer to join our ...
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Quality Engineer
3 weeks ago
Bisly Oklahoma City, United StatesPermanent employee,Full-time · Remote, · Tallinn · Your mission · As a · Quality Engineer · at Bisly you will play a pivotal role in ensuring the high quality and reliability of both our software and hardware products. This position involves working closely with our software ...
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Quality Engineer
3 weeks ago
Commonwealth Fusion System Oklahoma City, United StatesCommonwealth Fusion Systems (CFS) has the fastest, lowest cost path to commercial fusion energy. · CFS collaborates with MIT to leverage decades of research combined with groundbreaking new high-temperature superconducting (HTS) magnet technology. HTS magnets will enable compact ...
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Quality Engineer
2 weeks ago
Lumicity Oklahoma City, United StatesPlease apply or send your resume to · The Quality Engineer is responsible for overseeing the quality assurance of medical devices, from initial design through manufacturing and post-market surveillance. This role ensures that all products are manufactured in compliance with ISO ...
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Quality Engineer
1 week ago
Syntron Material Handling Group Oklahoma City, United StatesOverview · Individual works under the direction of the Quality Manager, performing quality inspections, root causeanalyses, implementing corrective actions, writing relevant reports, and leading improvement projects. · Responsibilities · Exemplary Duties/Responsibilities · Lea ...
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Quality Engineer
4 days ago
ATC Drivetrain Oklahoma City, United StatesSUMMARY · Ensuring Customer Satisfaction through continuous process quality development through management of: Process Control Plans (PCP), PFMEA. Effectiveness is measured through: RPN reduction (PFMEA), in process yield (FPY) and warranty reduction (W as a % of sales) · ESSENTI ...
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Northrop Grumman Oklahoma City, United StatesAt Northrop Grumman, our employees have incredible opportunities to work on revolutionary systems that impact people's lives around the world today, and for generations to come. Our pioneering and inventive spirit has enabled us to be at the forefront of many technological advanc ...
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Quality Control Engineer
1 week ago
Integrus Solutions Oklahoma City, United StatesAre you a seasoned Quality Control Engineer with a passion for excellence and a drive for continuous improvement? · Look no further We're seeking a dynamic individual to lead our client's quality initiatives and ensure the highest standards across their operations. If you thrive ...
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Senior Quality Engineer
3 weeks ago
Commonwealth Fusion System Oklahoma City, United StatesCommonwealth Fusion Systems (CFS) has the fastest, lowest cost path to commercial fusion energy. · CFS collaborates with MIT to leverage decades of research combined with groundbreaking new high-temperature superconducting (HTS) magnet technology. HTS magnets will enable compact ...
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Manufacturing Quality Engineer
2 weeks ago
DSJ Global Oklahoma City, United StatesDSJ Global is partnered with a leading company in the High-Performance Power Modules industry. This company designs and manufactures power converters, power supplies, and other power management solutions. They are looking to add a Manufacturing Quality Engineer with a focus in Yi ...
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Quality Engineering Director
1 week ago
Renu Contracting & Restoration Oklahoma City, United StatesAbout us · VulcanForms builds and operates advanced digital infrastructure enabling the world's critical industries to innovate, grow, and deliver sustainable impact. Founded in 2015, VulcanForms invented and commercialized the world's first industrially scalable laser metal add ...
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Head of Quality Engineering
3 weeks ago
Constant Contact Oklahoma City, United StatesWe have an opening for a Head of Quality Engineering (QE) to lead a team that helps improve the quality, deliverability, and user experience of CTCT's product offerings. You will lead a highly collaborative QE team that is engaged with every phase of the software development life ...
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Quality Assurance Engineer
3 weeks ago
Hatchpad Oklahoma City, United StatesHatch IT is partnering with HSI to find a Quality Assurance Engineer: · About The Role: · The Quality Assurance Engineer is responsible for product and process quality through implementing and maintaining Quality Assurance Programs & Plans, an ISO 9001 Quality Management System, ...
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Senior Quality Engineer
3 weeks ago
BioTalent Oklahoma City, United StatesIntroduction · We are working with a catheter manufacturer seeking a · Senior Quality Engineer · to join their team out of Greater Boston. You will be responsible for the entire supply quality management process as well as leading CAPA initiatives for new and sustained products ...
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Supplier Quality Engineer
5 days ago
Firefly Aerospace Oklahoma City, United StatesSupplier Quality Engineer - Careers At Firefly Aerospace · Career Opportunities with Firefly Aerospace · Come be a part of the 21 st · Century Space Race · Careers At Firefly Aerospace · Share with friends or Subscribe · Current job opportunities are posted here as they becom ...
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Senior Quality Engineer
1 week ago
MACOM Oklahoma City, United StatesMACOM designs and manufactures semiconductor products for DataCenter, Telecommunication and Industrial and Defense applications.Headquartered in Lowell, Massachusetts, MACOM has design centers and salesoffices throughout North America, Europe and Asia. MACOM is certified to theIS ...
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Associate Quality Engineer
1 week ago
The Boeing Company Oklahoma City, United StatesJob Description · At Boeing, we innovate and collaborate to make the world a better place. From the seabed to outer space, you can contribute to work that matters with a company where diversity, equity and inclusion are shared values. We're committed to fostering an environment f ...
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Senior Quality Engineer
5 days ago
Belcan Oklahoma City, United StatesJob Search · Back to Job Search Results · Job Details · Quality Engineering · Senior Quality Engineer Devens,MAPosted:5/15/2024 · Job Description · Job Number: · 349000 · Category: · Quality Engineering · Details: · Job Title: Senior Quality Engineer · Pay Rate: $110k + ...
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Quality Engineer II
4 weeks ago
Avantor Oklahoma City, United StatesAvantor, a Global Fortune 500 company is looking for a dedicated Quality Engineer II to optimize our Avantor Fluid Handling organization. This Devens, MA based role is full-time, on-site. · If you have quality engineering experience – let's talk · Highschool diploma with 7 + year ...
Principal Quality Engineer - Oklahoma City, United States - CybSafe
Description
Evolved By Nature team is seeking a Principal Quality Engineer, responsible for driving and supporting all aspects of the quality system, quality through new product introductions, and quality within manufacturing.
Responsibilities:
Requirements:
Skills & Abilities:
Requirements:
We have developed molecules from our Activated Silk(tm) technology to create natural, higher performing ingredients that raise the quality and reduce the footprint of the products we need and love.
Science meets commerce at our new home, a cutting-edge facility featuring state-of-the-art chemical laboratories, a contemporary wellness center, and creative marketing studio.
To learn more about who we are, what we make, and where we work, visit URL#J-18808-Ljbffr