Quality Manager

Quality ManagerWe love what we do! At Aspen Surgical we live our values of Customer Focus, Integrity, Accountability, Collaboration, and Innovative Spirit every day. This caring dedication creates and builds exceptional products that drive the industry standard making a real and lasting impact on people's lives around the world. We strive to be the best, while providing the tools, resources, and support needed to set our team members up for success.The Quality Manager serves as the designated Quality Management Representative (QMR) for all aspects of the Quality System within our chemical mixing / medical device manufacturing operation. This role has responsibility for planning, directing, and executing activities of our quality assurance, quality engineering, supplier quality, and quality control programs including strategic leadership for related activities, assuring the development, application, and maintenance of quality standards for processes, materials, and products. This role is also responsible for the achievement of quality objectives and operational targets, corrective action, and the implementation and maintenance of an overall effective and compliant Quality System.In This Position, You Will Have the Opportunity To:Serve as the Quality Management Representative (QMR) for the manufacturing facility, including hosting third party audits and inspections, organizing and conducting periodic Management Reviews of the Quality SystemCarry out leadership responsibilities in accordance with the organization's policies and applicable laws which includes interviewing, hiring, developing and training employees; planning, assigning, and directing work; appraising performance; rewarding and coaching employees; addressing complaints and resolving problemsEnsure all required investigations (i.e. complaints, NCs) are robust, thorough, and completed in a timely mannerChampion and lead continuous improvement, VIP, and standard work effortsChair the site's Corrective Action Board (CAB) and drive the CAPA program by ensuring opportunities are well documented, timelines are adhered to and status is reported to management on a routine basisOversee activities associated with calibration of Inspection, Measure, and Test Equipment (IM&TE) including standards, recall, review/approval of records, and out of tolerance investigationsLead, maintain and create efficiencies in the Quality Management System to fulfill both domestic and international quality system requirements (e.g. FDA's QMSR, ISO 13485, and other international standards)Host FDA/ISO and other regulatory agencies or customers for auditsSupport product integrations associated with acquisitions and new product developmentEnsure the effective maintenance of Device History Records, and other quality documentsManage the internal audit program including training internal auditors, creating and maintaining internal audit schedules, assuring internal audits are performed and completed according to approved scheduleMonitor the health and well-being of the QMS through quality trending, analytics and established KPIsWhat You Need to Succeed in This Position:Bachelor's Degree in Engineering or a related technical discipline such as, Chemistry or Biology or equivalent combination of education and experienceA minimum of 5-8 years of quality assurance experience in a medical device, pharmaceutical, or regulated manufacturing environment.A minimum of 1-3 years' experience managing quality team members.Industry or discipline specific certification a plus (CQE, CQA, CMQ/OE, Lean, Six Sigma, etc)Experience in chemical mixing, liquid formulation, or filling operations preferred.Displays developed interpersonal skills: leadership, team orientation, ability to communicate at all levelsAbility to make effective decisions and maintain effectiveness under changing circumstances and prioritiesTeamwork, communication, positive attitude required to support the manufacturing environmentExtensive experience in problem solving – able to perform root cause analysis and implement effective corrective actionsAble to effectively manage and complete multiple projects simultaneouslyExcellent computer skills including but not limited to Microsoft Office SuiteKnowledge of quality systems including the quality manual, quality policy and applicable procedures and work instructionsAbility to support the establishment, implementation, and maintenance of the quality system in accordance to FDA Quality Management System Regulation, ISO 13485, and European Union Medical Device Directives.We're proud to be an equal opportunity employer- and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status. Aspen Surgical