Medical Device Quality Assurance Specialist
1 month ago
Our client, a leading medical device manufacturer, is seeking a Quality Assurance Engineer to join their team. The successful candidate will be responsible for ensuring the quality and compliance of our medical devices.
Key Responsibilities:- Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
- Lead and implement various product and process improvement methodologies.
- Review the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
- Lead in the completion and maintenance of risk analysis.
- Lead generation and completion of protocols and reports for test method validations.
- Interface with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommend process monitoring devices where applicable.
- Develop various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval, and implementation of Incoming, In-Process, and Final Inspection procedures.
- Ensure that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
- Relevant Quality Assurance Engineering Experience
- Bachelor's Degree (Science Related)
- 3+ years of experience in a Cleanroom environment
- Strong Medical Device Manufacturing Experience
- Good knowledge of statistical tools and appropriate use of Design of Experiments (DOE) when developing recommendations
- Excellent communication and interpersonal skills
- Working knowledge of FDA, EU MDR, ISO 13485:2015, 21 CFR, and cGMPs
- Competitive base salary between $80,000-$95,000, depending on experience and skills
- Bonus opportunity up to 5%
- Comprehensive benefits package including Medical, Dental, and Vision
- Life and AD&D Coverage
- Short-term disability coverage
- 15 PTO Days + 10 holidays
- 401(k) with 6% company match
-
Quality Assurance Specialist
1 month ago
Saint Charles, Missouri, United States Michael Page Full timeJob Title: Quality Assurance SpecialistContribute to the success of a global medical device product line utilized in surgeries.About the Role:We are seeking a Quality Assurance Specialist to join our growing Quality team. As a key member of our team, you will be responsible for ensuring the quality and compliance of our medical devices.Key...
-
Quality Assurance Specialist
4 weeks ago
Saint Charles, Missouri, United States Michael Page Full timeJob DescriptionThe Quality Assurance Engineer will be responsible for ensuring the quality and integrity of medical devices manufactured by our client. This includes supporting regulatory and agency inspections, audits, investigations, and inquiries regarding product design and manufacturing quality.Key Responsibilities:Supports regulatory and agency...
-
Senior Quality Assurance Specialist
4 weeks ago
Saint Charles, Missouri, United States Michael Page Full timeJob SummaryWe are seeking a highly skilled Quality Assurance Engineer to join our team at Michael Page. As a Quality Assurance Engineer, you will be responsible for ensuring the quality and integrity of our medical device products.Key Responsibilities:Support regulatory and agency inspections, audits, investigations, and inquiries regarding product design...
-
Quality Assurance Specialist
4 weeks ago
Saint Charles, Missouri, United States Millstone Weber LLC Full timeJob SummaryThe Quality Assurance Specialist performs and documents routine field and laboratory testing/inspections as required by the Project Quality Management Plan or as directed by the Construction Quality Manager.Key ResponsibilitiesConduct testing and inspections of concrete, soil, and aggregate materials.Maintain and calibrate company-owned testing...
-
Quality Assurance Specialist
3 weeks ago
Saint Charles, Missouri, United States Ensign-Bickford Aerospace and Defense Full timeAs a Quality Assurance Specialist at Ensign-Bickford Aerospace and Defense, you will play a crucial role in ensuring the highest standards of quality in our palatability enhancer manufacturing process.About the Job:Support all aspects of palatant manufacturingCollaborate with industry experts to solve real-world challenges and implement process...
-
Quality Assurance Specialist
4 weeks ago
Saint Charles, Missouri, United States ITW Full timeThe Quality Technician role at ITW Marking & Coding is a critical position that requires a high level of attention to detail and a strong understanding of quality control processes.Key Responsibilities:Perform visual inspections, measurements, and tests to ensure product quality and integrityVerify and inspect mechanical and electronic parts and assemblies...
-
Quality Assurance Specialist
4 weeks ago
Saint Charles, Missouri, United States PDS Tech Full timeJob Summary:We are seeking a skilled contract worker to assist our team in drafting Quality Test Procedures for Pre Compliance hardware testing in Honeywell System Sensor. This role is crucial in NPI product validation process.Key Responsibilities:Drafting & Performing Quality Test Procedures:Collaborate with internal teams to understand current processes...
-
Quality Assurance Specialist
4 weeks ago
Saint Charles, Missouri, United States Diagraph Full timeJob DescriptionAt Diagraph, we pride ourselves on delivering exceptional quality solutions to meet our customers' evolving product identification needs. As a leading manufacturer and distributor of inkjet coders, automated labeling systems, thermal transfer inkjet coders, and laser coders, Diagraph engineers and builds products to help manufacturers get...
-
Quality Assurance Specialist
1 month ago
Saint Peters, Missouri, United States 804 Technology Full timeJob OverviewAs a Supplier Quality Specialist at 804 Technology, you will play a critical role in ensuring the quality of our suppliers and their products. This position requires a strong understanding of aerospace industry standards and regulations, as well as excellent communication and problem-solving skills.Key ResponsibilitiesDevelop and maintain...
-
Quality Assurance Specialist
4 weeks ago
Saint Charles, Missouri, United States Ensign-Bickford Industries Full timeQuality Intern OpportunityAfB International is seeking a Quality Intern to support all aspects of our palatant manufacturing located in St. Charles, Missouri.The primary responsibility of this position will include data collection and interpretation, root cause analysis and corrective action implementation, and process defect identification and...
-
Quality Assurance Manager
4 weeks ago
Saint Charles, Missouri, United States Zoltek-Toray Group Full timeJob Summary:The Quality Control Manager will oversee the implementation and maintenance of quality system policies in line with company guidelines and regulatory standards. This role requires a strong understanding of quality management systems and the ability to drive continuous improvement in a manufacturing environment.Key Responsibilities:Oversee the...
-
Quality Assurance Specialist
4 weeks ago
Saint Charles, Missouri, United States Ensign-Bickford Aerospace and Defense Full timeJob Description:At Ensign-Bickford Aerospace and Defense, we are seeking a talented Quality Intern to support all aspects of our palatability manufacturing process. As a member of our team, you will have the opportunity to learn and apply lean manufacturing standards, including process flow, kaizen, and Six Sigma techniques.Responsibilities:Data collection...
-
Advanced Quality Assurance Specialist
1 month ago
Saint Charles, Missouri, United States MiTek USA Full timeJob Title: Advanced Quality EngineerJob Summary:The Advanced Quality Engineer plays a critical role in ensuring the highest standards of quality throughout the product development and manufacturing processes. This individual will be responsible for leading advanced quality planning initiatives, implementing continuous improvement measures, and driving root...
-
Emergency Medical Technician
4 weeks ago
Saint Charles, Missouri, United States Global Medical Response Inc Full timeJob Summary:We are seeking a skilled Paramedic to join our team at Global Medical Response Inc. As a Paramedic, you will be responsible for providing advanced medical care to patients in emergency situations.Responsibilities:Assess each call situation to determine the best course of action while working with progressive Paramedic protocols.Utilize your...
-
Beer Quality Assurance Specialist
4 weeks ago
Saint Charles, Missouri, United States A Head for Profits Full timeJob SummaryWe are seeking a highly motivated and detail-oriented individual to join our team as a Draft Beer Quality Technician. As a key member of our quality control team, you will be responsible for ensuring that local bars and restaurants serve the highest quality pints of draft beer.Responsibilities and DutiesClean and maintain draft beer systems in...
-
Quality Assurance Specialist
4 weeks ago
Saint Ann, Missouri, United States Yoh Full timeThe Quality Control Scientist role at Yoh is a dynamic position that requires a strong background in quality assurance and regulatory compliance. As a member of our team, you will be responsible for inspecting and sampling incoming materials, including bulk gases and cell banks, to ensure they meet the highest standards of quality.Key responsibilities...
-
Quality Assurance Manager
4 weeks ago
Saint Charles, Missouri, United States Zoltek-Toray Group Full timeJob Summary:The Quality Control Manager will coordinate the implementation and maintenance of the quality system policies in line with company guidelines, and with regulatory and industry standards.This role will oversee the design, implementation, and maintenance of Quality Management System, ensuring quality measures are met at all stages of production.The...
-
Quality Assurance Manager
1 month ago
Saint Charles, Missouri, United States Zoltek-Toray Group Full timeJob SummaryThe Quality Control Manager will oversee the implementation and maintenance of quality system policies in line with company guidelines, regulatory, and industry standards. This role will ensure the quality of products and services meets customer expectations and regulatory requirements.Key ResponsibilitiesDevelop and implement quality systems to...
-
Environmental/Air Quality Specialist
4 weeks ago
Saint Charles, Missouri, United States Civil and Environmental Consultants Full timeJob SummaryWe are seeking an Environmental/Air Quality Specialist to join our team at Civil and Environmental Consultants, Inc. (CEC). As an Environmental/Air Quality Specialist, you will be involved in a variety of environmental and air quality projects, providing client-focused customer service in the manufacturing, energy, mining, and real-estate...
-
Culinary Specialist
4 weeks ago
Saint Charles, Missouri, United States Lake St. Charles Retirement Center Full timeCulinary Position OverviewLake St. Charles Retirement Center is seeking a skilled Culinary Specialist to join our Food Nutrition Service Team. As a Culinary Specialist, you will be responsible for maintaining high standards of quality food preparation, production, service, and portion control.Key Responsibilities:Assist in receiving and storing food and...