- Manage projects, efforts, and changes of moderate complexity and scope including but is not limited to, process performance qualifications, sterilization validations, stability studies, packaging simulated distribution studies, equipment validations, etc.
- Communicate quality standards and requirements within the organization.
- Project management with a focuses on planning and organizing a project and its resources from initiation through planning, execution, monitoring and control through closure.
- Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
- Participate in continuous improvement activities that directly impact performance measures.
- Leads product quality investigations in support of CAPA, complaints and nonconforming material processes.
- Collect, analyze and interpret statistical data, performs analyses and provide reports as required.
- Takes an active role in leading, and reviewing design and manufacturing changes.
- Assists with internal and external audit activities.
- Leads Quality Assurance and product quality improvements in cross-functional initiatives.
- Supports day-to day manufacturing activities.
- Specialize in the areas of production control, incoming material, product evaluation and reliability, inventory control, and development as they apply to product or process quality.
- Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
- Overlook and participate change approval process for risk assessment, verification, and validation.
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
- Performs advanced areas of work for the professional field
- Identifies key barriers/core problems and applies problem-solving skills in order to deal creatively with complex situations. Troubleshoots and resolves complex problems.
- Makes decisions under conditions of uncertainty, sometimes with incomplete information, that produce effective end results
- Independently performs assignments with instruction limited to results expected. Determines and develops approach to solutions
- Receives technical guidance only on unusual or complex problems or issues
- May manage elements/portions of a budget/project
- Seasoned professional contributor with responsibility for an advanced area of work in the professional field
- May be responsible for entire projects or functions having modest scope/impact or portions of projects having considerable scope/impact to department results
- BS degree in Science, biomedical, mechanical, industrial or similar engineering discipline
- 3+ years of Quality Assurance /Engineering experience in an FDA-regulated industry
- Prefer cGMP pharmaceutical industry, biologics industry experience; medical device or tissue processing industries considered
- Prefer Certified Quality Engineer (CQE) or other similar Quality/reliability certifications
- Prefer Six Sigma certification
- Knowledge of FDA, AATB, ISO, and other state/federal/international regulations and standards
- Experience in utilization of statistical techniques such as the design of experiments, hypothesis testing, SPC, etc.
- Excellent oral, written, and interpersonal communication skills
- Proficient in Microsoft Office (Excel, Word, etc.) and Minitab
- Organized, flexible, and able to multi-task while maintaining a high level of efficiency and attention to detail
- Must show aptitude to develop appropriate skills needed for the job
-
Sr. Quality Engineer
3 weeks ago
MiMedx Marietta, United States Full timePOSITION SUMMARY: · In this exciting role as an Validation Senior Quality Engineer, you will design or plan protocols for equipment or processes to produce tissue-based products, biologic drug products and medical device products meeting internal and external purity, safety and ...
-
Software Quality Engineer
2 weeks ago
Lockheed Martin Marietta, United States· Description:We are Lockheed Martin · At Lockheed Martin Aeronautics, we're taking innovation to the next level. From designing the most advanced air vehicle to designing aircraft that defies gravity, our engineers live on the cutting edge of technology. Never have the opportun ...
-
Quality Assurance Engineer
1 week ago
Vanderlande Industries B.V. Marietta, United StatesJob Title · Quality Assurance Engineer · Job Description · Job Description - QA Engineer - JR26415 · The Quality Engineer is part of Supply Chain Quality and drives the activities to ensure materials delivered to project teams conform to specifications, and are purchased from ...
-
Senior Quality Assurance Engineer
3 weeks ago
Third Eye Software Marietta, United StatesJob Description · Job Description-- NO AGENCIES, please -- · Primary Requirements: Please Review Before Applying · In an effort to respect and value your time, we've positioned our primary requirements at the beginning. We urge you to review them thoroughly to ensure a mutual fit ...
-
Senior Quality Engineer
3 weeks ago
Advanced Recruiting Partners Marietta, United StatesPOSITION SUMMARY: · In this exciting role as an Validation Senior Quality Engineer, you will design or plan protocols for equipment or processes to produce tissue-based products, biologic drug products and medical device products meeting internal and external purity, safety and q ...
-
Sr. Quality Engineer
3 weeks ago
MiMedx Marietta, United StatesPOSITION SUMMARY:In this exciting role as an Validation Senior Quality Engineer, you will design or plan protocols for equipment or processes to produce tissue-based products, biologic drug products and medical device products meeting internal and external purity, safety and qual ...
-
Sr. Quality Engineer
3 weeks ago
MiMedx Marietta, United StatesPOSITION SUMMARY: · In this exciting role as an Validation Senior Quality Engineer, you will design or plan protocols for equipment or processes to produce tissue-based products, biologic drug products and medical device products meeting internal and external purity, safety and ...
-
Quality Assurance Engineer
2 weeks ago
Vanderlande Industries Marietta, United StatesJob Title · Quality Assurance Engineer Job Description · Job Description - QA Engineer - JR26415 · The Quality Engineer is part of Supply Chain Quality and drives the activities to ensure materials delivered to project teams conform to specifications, and are purchased from ap ...
-
Technician in Quality Engineering
2 weeks ago
Eclipse Innovations Colony, United StatesAbout the Company · As a system partner of the office furniture industry, we specialize in the development and production of functional fittings made of metal and plastic. As one of the leading companies in Europe, we strive to quickly and flexibly fulfill individual customer req ...
-
Process Improvement/Value/Quality Engineer
3 weeks ago
Georgia Institute of Technology Smyrna, United StatesThe Process Improvement/Value/Quality Engineer works as part of a team developing approaches to improve enterprise-level sustainment of DoD and commercial aircraft. Analyzes aircraft sustainment processes, tools and datasets, creates updated processes and toolsets and employs con ...
-
Quality Engineer
4 days ago
Inspire Brands Atlanta, United StatesJOB DESCRIPTION We are seeking an experienced Functional Test Automation Engineer to join our team. The ideal candidate will have a strong background in software testing, possess expert knowledge in automation across web, API, and mobile platforms, and be a skilled communicator. ...
-
Quality Engineer
1 week ago
Selectek Staffing Solutions Woodstock, United StatesSelectek is looking for a Quality Engineer who will develop processes and procedures to ensure equipment is being manufactured to code while offering process improvements. Required: BS or related certifications 5 years of Quality Engineering experien Quality Engineer, Engineer, T ...
-
Concrete Quality Control Engineer
3 weeks ago
Martin Concrete Kennesaw, United StatesJob Description · Job DescriptionSalary: · Quality Control Engineer is responsible for quality control related activities to fulfill expectations and specific contract requirements of concrete construction project stakeholders. The work involves overseeing and assuring quality w ...
-
Quality Engineer
3 weeks ago
Umdasch Group Roswell, United StatesCompany Description · AT-PAC is world leading scaffolding manufacturer and supplier offering a high quality and globally certified Ringlock system and supplementary access products to industrial and construction customers across the oil & gas, mining, refining, power, infrastruc ...
-
Process Improvement/Value/Quality Engineer
3 weeks ago
Georgia Tech Research Institute Smyrna, United StatesProcess Improvement/Value/Quality Engineer (Experienced) - SEAL - Open Rank (Hybrid) · Submit Resume · ID: · Type: Researchers · Location: Smyrna, GA · Categories: Aeronautics, Mechanical Design & Analysis, Military Vehicles, Project/Program Management, Other · Overview: · ...
-
Quality Engineer
2 weeks ago
Collabera Alpharetta, United StatesHome · Search Jobs · Job Description · Quality Engineer · Contract: Alpharetta, Georgia, US · Salary: $40.00 Per Hour · Job Code: · End Date: · Days Left: 22 days, 3 hours left · Apply · About the Role: We are looking for a Quality Engineer to join our team and work on m ...
-
Quality Engineer
1 day ago
Insight Global Peachtree Corners, United StatesA partner of Insight Global is looking for a quality engineer to join their solar cell manufacturing plant in Norcross, GA. We are seeking a detail-oriented Quality Engineer to ensure the manufacturing production lines run smoothly and generate a consistently suitable output of P ...
-
Quality Engineer
3 weeks ago
Trident Consulting Atlanta, United StatesJob Title: Quality Engineer · Job Location: Atlanta, GA · Job Type: Contract · **** Only H1B Candidates *** · Job description · QUALIFICATIONS:5+ years of QA Test engineering experience · Strong analytics background · Experience with coding using JAVA with Selenium for front e ...
-
Quality Engineer
1 week ago
Hanwha Q CELLS USA Corp. Cartersville, United StatesSUMMARY · The Quality Engineer is responsible for incoming inspections, product line patrol, outgoing quality control, and updating factory internal quality rules, all in accordance with high industry standards and within manufacturing timescales. · RESPONSIBILITIES · •Conduct ...
-
Quality Engineer
1 week ago
Hanwha Q CELLS USA Corp. Cartersville, United StatesSUMMARYThe Quality Engineer is responsible for incoming inspections, product line patrol, outgoing quality control, and updating factory internal quality rules, all in accordance with high industry standards and within manufacturing timescales.RESPONSIBILITIES · •Conduct inspecti ...
Senior Quality Engineer, - Marietta, United States - Advanced Recruiting Partners
Description
POSITION SUMMARY:In this exciting role as an Validation Senior Quality Engineer, you will design or plan protocols for equipment or processes to produce tissue-based products, biologic drug products and medical device products meeting internal and external purity, safety and quality requirements. This position will ensure compliance with all applicable, regulatory requirements, company policies, and standards. You will have the opportunity to drive a culture of continuous improvement by deploying sound engineering fundamentals to achieve quality objectives and ultimately yielding better patient outcomes.
ESSENTIAL DUTIES AND RESPONSIBILITIES: