Quality Manager
3 weeks ago
Job Summary Interested in this role You can find all the relevant information in the description below. Responsible for managing the quality and compliance for applicable products and processes for assigned department(s). Adapt departmental plans and priorities to address resource and operational challenges. Job Description Responsibilities: Ensure quality and regulatory compliance with applicable regulations (ex. QSR, GMP,ISO) pertaining to the applicable life cycle and regions of distribution for the product. Acts as a liaison with the Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products and customer satisfaction. Manage complaints and develop new approaches to solve problems identified during the investigation process. Identify and manage the execution of continuous improvement projects. Assist the division in product evaluation from a quality assurance and regulatory compliance standpoint. Assist in the planning of the design, testing, inspection, and process validations to assure quality products or components. Ensure all quality issues are resolved to customer satisfaction, in a timely manner. Resolve issues relating to product or production quality by interfacing with internal and external customers. Management responsibilities include: Typically oversees professional employees/teams OR typically manages non-professional employees through Supervisors in manufacturing, distribution or office environments Day-to-day operations of a group of employees; May have limited budgetary responsibility and usually contributes to budgetary impact; Interpret and execute policies for departments/projects and develops. Recommend and implement new policies or modifications to existing policies. Provide general guidelines and parameters for staff functioning. Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies. Requirements: Education Bachelor’s degree in Engineering, Science, or Technical Field. Work Experience At least 4 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk management, including working in compliance with QSR/GMP/ISO requirements or other regulated industries (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR). Knowledge / Skills / Abilities Broad technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR etc.) Proficiency in analyzing and reporting data in order to identify issues, trends, or exceptions to drive improvement of results and find solutions. Demonstrated ability to control and coordinate concurrent projects, competing priorities and critical deadlines. Advanced level skill in Microsoft Excel (for example: using AVERAGE function, merging and centering cells, printing centered page and/or creating apivot table). Position requires travel up to 25% of the time for business purposes (within state, out of state and/or internationally). Preferred Requirements: Work Experience At least 2 years of supervisory/managerial experience. Experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries. Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $116,000.00 - $174,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. xrczosw Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
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Manager Quality Process
3 weeks ago
Northfield, MN, United States Medline Industries - Transportation & Operations Full timeJob Summary Responsible for managing a team of quality process specialists as well as leading strategic implementation of items and events related to Quality Systems Management and CAPA. Manage the Quality data integrity for Medline products including but not limited to, sterile products, medical devices, pharmaceuticals, biologics, cosmetics, medical...
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Quality Engineering S
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Quality Engineering S
3 weeks ago
Northfield, MN, United States Medline Industries - Transportation & Operations Full timeUnder broad supervision, responsible for independently setting basic quality standards for both in-process while leading efforts to develop methods for testing, sampling and training. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMR’s, product specifications, design control files, and CE...
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Principal Specialist Quality Process
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Northfield, MN, United States Medline Industries - Transportation & Operations Full timeJob Summary Lead strategic project implementation for all activities related to system management and may provide expertise and guidance for team members. Responsible for independent review of CAPA/investigation content for adequacy and compliance, including comprehensive ability to use critical thinking to evaluate events and the CAPA author team’s...
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Software Data Quality
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Quality Investigator
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Sr. Quality Process Specialist
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Quality Manager
3 weeks ago
Minneapolis, MN, United States Minnesota Staffing Full timeQuality Manager QTS offers critical end-of-line services for medical device OEMs including finished device assembly, packaging, and sterilization management. QTS is part of the Cretex Medical family of companies. Responsibilities include building, managing, and leading the quality department staff, working in partnership with sales, engineering, procurement,...