Quality Assurance Specialist

L&R USA, Inc.
United States, Wisconsin, Milwaukee
3880 West Wheelhouse Road (Show on map)
Nov 11, 2024
Company Overview L & R develops, manufactures, and distributes medical devices and related articles throughout the world. Employee commitment and dedication is essential to the L & R Corporate values of providing the highest quality products, superior customer service with good product knowledge and compassion to our customers including patients, therapists, and medical professionals. Position Summary The job of a Quality Associate is a highly focused position to ensure that the products manufactured in the organization fits the purpose and meets the customer expectations and legal compliance. The Quality Associate develops and coordinates special activities and programs necessary to meet and maintain quality standards and reliability of manufactured products. Primary Responsibilities: Accept or reject raw materials and packaging as necessary based on compliance to specifications. Maintain Vendor Approval Program Understanding, evaluating, and executing the tests and procedures properly and investigating the product modifications. Maintaining and setting up documentation and control procedures Perform inspection of finished goods prior to shipping - this includes inspecting and noting defects, workmanship, cleanliness, and packaging of the products based on specifications listed for finished goods Create CoCs, CoAs, and all other test reports required to ship with production orders, and maintain a copy for quality records Review returned product upon arrival and process appropriate paperwork Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the customer and the quality of the product. Enter, monitor, and maintain instrument calibration and paperwork Participate in the operations of the ISO Quality Management System Other duties as assigned Qualifications: Knowledge of ISO, FDA, GMP, Deviation, CAPA, and Change Control Systems 5+ years of manufacturing or industrial experience BS preferred Knowledge and Skill Requirements: An understanding of manufacturing process and practical knowledge of current regulations and cGMPs, are needed to perform this position effectively. Required skills include: Organizing, planning, and problem-solving skills. Ability to work as a part of a team- with enthusiastic, cooperative and positive behavior Proficient in Microsoft Office Suite Excellent analytical and mechanical skills- good statistical and numerical ability. Excellent communication skills, both oral and written, at all levels within a manufacturing environment Ability to prioritize multiple projects, working in a fast pace and ever-changing environment Physical Demands: The physical requirements for this position require frequent standing and intermittent walking, bending, sitting, and lifting of parts that may at times be in excess of 50#. Additional duties and responsibilities may be added to this Job Description at any time. The Job Description does not state or imply that these are the only activities to be performed by the employee(s) holding this position. Employees are required to follow any other job-related instructions and to perform any other job-related responsibilities as required by their supervisor.