Quality Assurance Manager
3 weeks ago
Job Summary:
We are seeking a highly skilled Quality Assurance Manager to join our team at Cooper Companies. The successful candidate will be responsible for ensuring compliance with regulatory requirements and maintaining current certificates.
Key Responsibilities:
* Manage and communicate with CVI management concerning all major regulatory affairs and quality system issues related to manufacturing, design control, and compliance with applicable regulations.
* Research, recommend, and implement best practices, and contribute to both the strategic and operational functions for the site.
* Share the responsibilities of the Person Responsible for Regulatory Compliance with RAQA Specialist and be responsible for the clauses of Article of the EU Medical Devices Regulation (MDR) 2017/745.
Essential Functions & Accountabilities:
* Achieves quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
* Writes, reviews, and approves as needed validation protocols (e.g., IQ, OQ, PQ) for manufacturing equipment and processes.
* Prepares and reviews changes to Quality Manual, Device Master Records, and product technical files, communicating same to all departments involved.
* Manages the internal audit program at Paragon to ensure compliance with applicable regulations.
* Reviews, evaluates, and resolves customer complaints for quality-related problems. Implements corrective actions as necessary.
* Acts as management representative for all FDA inspections, ISO audits, and other external audits.
* Reviews and approves all new vendors related to the quality system. Monitors and assesses reported vendor performance problems from all personnel that conduct purchasing. Conducts purchasing of all QA inspectional equipment and supplies.
Regulatory Intelligence:
* Keeps ahead of US FDA, Canadian, EU MDR, and other applicable regulatory requirements and changes within the regulatory registration processes.
* Advises management on future International regulations, based upon thorough knowledge of applicable regulations.
* Reviews and approves Regulatory Assessment documents, as required for post-market change control.
Qualifications:
* Minimum of 5 years of experience in the Medical Devices Industry
* Strong knowledge of regulatory requirements related to product registration processes for Medical Devices.
* Application of quality system and regulatory requirements from product concept through product distribution.
* Working knowledge of interacting with regulatory entities, notified bodies, and other external regulators.
* Contact Lens experience is highly desirable
* Works effectively across different cultures and languages
* Strong technical acumen, computer skills, problem-solving ability, analytical, writing, and communication skills
-
Quality Assurance Manager
1 month ago
Gilbert, Arizona, United States Cooper Companies Full timeJob Title: Quality Assurance ManagerCooperVision, a division of CooperCompanies, is a leading manufacturer of soft contact lenses. We are seeking a Quality Assurance Manager to oversee all activities related to regulatory affairs and quality assurance for our CooperVision SEC Sherbrooke site.Key Responsibilities:Manage and communicate with CVI management...
-
Quality Assurance Manager
3 weeks ago
Gilbert, Arizona, United States Cooper Companies Full timeJob DescriptionThe Cooper Companies is seeking a highly skilled Quality Assurance Manager to oversee all activities related to regulatory affairs and quality assurance for our SEC Sherbrooke site. This position is responsible for ensuring compliance with applicable regulations and maintaining current certificates.Key ResponsibilitiesManage and communicate...
-
Quality Assurance Manager
4 weeks ago
Gilbert, Arizona, United States Isagenix Full timeJob SummaryThe Quality Assurance Manager will lead the QA team in ensuring the highest quality of our products through both manual and automated testing processes. This role will possess a strong technical background in software testing, a keen eye for detail, and proven leadership abilities.Key ResponsibilitiesDevelop and execute a comprehensive QA strategy...
-
Quality Assurance Specialist
3 weeks ago
Gilbert, Arizona, United States Phoenix Defense Full timeAt Phoenix Defense, we're seeking a highly motivated Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you'll play a critical role in ensuring the quality of our products and services.Key Responsibilities:Perform quality control inspections, checks, and tests during the manufacture of products.Perform receiving...
-
Quality Assurance Specialist
1 month ago
Gilbert, Arizona, United States Midway Staffing Full timeJob OverviewMidway Staffing is seeking a skilled Quality Assurance Technician to join our team. As a key member of our production team, you will be responsible for ensuring that our products meet the highest standards of quality, safety, and compliance with industry regulations.Key ResponsibilitiesConduct regular inspections and audits of production...
-
Director of Quality Assurance
4 weeks ago
Gilbert, Arizona, United States Airside MRO Inc Full timeJob DescriptionJob Title: Director of QualityReports to: VP of OperationsJob Summary:The Director of Quality is responsible for the management of Airside MRO's Quality Assurance/Quality Control departments. This includes compliance with all applicable CFRs, customer requirements, and company policies and procedures.Key Responsibilities:Directs and oversees...
-
Senior Quality Assurance Specialist
4 weeks ago
Gilbert, Arizona, United States Cooper Companies Full timeJob SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Cooper Companies. In this role, you will be responsible for ensuring the seamless integration of quality assurance processes across the organization.Key ResponsibilitiesCollaborate with cross-functional teams to integrate quality assurance processes across...
-
Senior Quality Assurance Specialist
4 weeks ago
Gilbert, Arizona, United States Cooper Companies Full timeCooperVision, a division of CooperCompanies, is a leading manufacturer of soft contact lenses. The company produces a range of daily disposable, two-week, and monthly contact lenses featuring advanced materials and optics.CooperVision has a strong heritage of solving vision challenges such as astigmatism, presbyopia, and childhood myopia. The company offers...
-
Quality Assurance Associate
4 weeks ago
Gilbert, Arizona, United States Randstad Full timeJob Summary:Are you looking to join a company with a global footprint in the logistics industry? We are hiring for a Quality Assurance Coordinator in Gilbert, AZ.Please read below for the job details:Responsibilities:Ensure that the company's products and services meet all quality standardsUnderstand and implement quality assurance principles and work...
-
Mission Assurance Engineer
1 month ago
Gilbert, Arizona, United States Northrop Grumman Full timeJob SummaryWe are seeking a highly skilled Mission Assurance Engineer to join our team at Northrop Grumman. As a key member of our integrated product team, you will be responsible for implementing and administering an effective Safety and Mission Assurance program in compliance with applicable customer contracts and guidelines.Key ResponsibilitiesImplement...
-
Quality Assurance Specialist II
4 weeks ago
Gilbert, Arizona, United States Phoenix Defense Full timeQuality Control Inspector II Job DescriptionAt Phoenix Defense, we are seeking a highly motivated professional to fill the position of Quality Control Inspector II. This role is a key part of our team, responsible for ensuring the highest quality standards in our aerospace manufacturing processes.Key Responsibilities:Quality Control Inspections: Perform...
-
Restaurant Manager
1 month ago
Gilbert, Arizona, United States Quality Brand Group Full timeRestaurant ManagerAt Quality Brand Group, we are seeking a skilled Restaurant Manager to lead our team and drive success in our Dunkin' locations. As a Restaurant Manager, you will be responsible for overseeing the daily operations of the store, ensuring exceptional customer service, and achieving sales and profitability goals.Key Responsibilities:Lead and...
-
Airport Operations Manager
4 weeks ago
Gilbert, Arizona, United States Wildflower Full timeAt Wildflower, we're seeking a motivated leader to support our management team in daily airport operations. As a Shift Lead, you'll direct hourly team members, execute standard processes, and ensure quality assurance. If you're passionate about delivering exceptional customer experiences and thrive in a fast-paced environment, this role is a great fit. Key...
-
Geotechnical Engineer
4 weeks ago
Gilbert, Arizona, United States Quality Testing Full timeAbout the Role:Quality Testing, LLC is seeking a Geotechnical Engineer to perform geotechnical analyses, assist with proposal development, and prepare and review design and construction submittals for geotechnical compliance with applicable codes, design standards, project requirements, and contract documents.The Geotechnical Engineer will serve as a...
-
Telecommunications Project Manager
4 weeks ago
Gilbert, Arizona, United States Pacific Network Solutions Full timeJob Title: Construction ManagerAbout the Role:Pacific Network Solutions is seeking a skilled Construction Manager to join our team in Gilbert, AZ. As a Construction Manager, you will be responsible for overseeing the day-to-day operations of our construction sites, ensuring that projects are completed on time, within budget, and to the highest quality...
-
Security Account Manager
4 weeks ago
Gilbert, Arizona, United States Allied Universal® Full timeJob Description:At Allied Universal, we are seeking a highly skilled and experienced Security Account Manager to join our team. As a Security Account Manager, you will be responsible for overseeing the day-to-day operations of an assigned account, including hiring, training, disciplining, and terminating staff.Key Responsibilities:Supervise the day-to-day...
-
Nurse Manager in Benign Hematology
3 weeks ago
Gilbert, Arizona, United States Banner Health Full timeJob SummaryBanner Health is seeking a skilled Nurse Manager to lead our Benign Hematology team. As a key member of our clinical leadership team, you will be responsible for planning and providing clinical support to patients and staff, demonstrating expertise in the assigned area, and providing leadership in clinical, financial, and personnel management...
-
Pharmacy Operations Manager
1 month ago
Gilbert, Arizona, United States Walgreens Full timeJob SummaryWe are seeking a highly skilled Pharmacy Operations Manager to join our team at Walgreens. As a key member of our pharmacy team, you will be responsible for overseeing the day-to-day operations of our pharmacy, ensuring efficient workflow and a positive patient experience.Key ResponsibilitiesOversee the selection, scheduling, and development of...
-
Drug Store Department Leader
3 weeks ago
Gilbert, Arizona, United States Fry's Food Stores Full timeJob SummaryCreate an exceptional customer experience through outstanding service and maintain a safe, clean environment that encourages customer loyalty. Achieve sales and profit goals for the department, monitoring and controlling quality assurance standards. Direct, support, and supervise all functions, duties, and activities for the Drug GM department,...
-
Quality Control Inspector II
4 weeks ago
Gilbert, Arizona, United States Phoenix Defense Full timeAt Phoenix Defense, we're seeking a highly motivated professional to fill the position of Quality Control Inspector II. This exciting opportunity will allow you to work on state-of-the-art modeling and simulation programs that prepare the nation's armed forces to protect and serve our country and allies throughout the world.We're looking for someone with a...