Quality Manager – Clinimark – Louisville, CO

Job title: Quality ManagerCompany: ClinimarkJob description: Job descriptionJob Title: Quality Assurance ManagerDepartment: QualityTheRole:Clinimark has identified the need to appoint a Quality Assurance Manager to support the testing quality function at Clinimark. The Quality Assurance Manager will manage customer, accreditation and regulatory body relationships, drive standardization and best practice in quality management systems and processes, and lead a culture of Quality excellence.This role reports directly into the General Manager. You will be an experienced Quality professional with the ability to work in partnership with operational and commercial colleagues. This is a key position, that will require you to support the development and execution of our clinical testing strategy, working with the direction of the Quality Director, Life Sciences. This role is in recognition of the growing importance of clinical testing in Clinimark and our desire to strengthen our position as a world-class provider of high-quality, accurate and cost-effective testing services.The primary function of the Quality Assurance Manager is to support the management, maintenance and development of the quality management system, manage accreditations, analyzing quality KPI’s, and customer approvals, working in collaboration with location and divisional operational leadership. The Quality Assurance Manager will be the primary point of contact and subject matter expert to support our operational colleagues in any audit preparation, implement post audit actions and follow up as well as issue resolution.The Quality Assurance Manager is expected to proactively maintain customer, accreditation and regulatory body relationships. Essential Duties andResponsibilities:• Develop and ensure compliance with Clinimark quality system and processes and perform internal audits related to the Clinimark scope of testing services• Provide Quality support and expertise to operational management. Support in audit preparation and post audit activity implementation• Establish and maintain strong relationships with clients, regulatory authorities and accreditation bodies.Ensure proactive management of all relevant customer relationships working with the General manager, the commercial team and peers• Identify and implement best practice in quality, technical processes and the quality management system• Ensure through personal continued professional development that changes in the technical, quality and regulatory landscape relating to clnical testing activities are anticipated and processes adjusted accordingly• Establish, demonstrate and promote a continuous improvement mind set within the business unit quality community• Participate and advise on adjustments to quality procedures and processes, as necessary• Promote Clinimark’s technical and quality capabilities through participation in participation in industry organizations, industry conferences and through written technical papers• Provide guidance and expert advice to management or other groups on systems, quality, risk management or process-related business improvement aspects• Support development of a world-class service provision in relation to clinical testingProvide leadership and representation of Clinimark to third party organizations, customers, accreditation bodies / committees, suppliers / vendors• Maintain high level of ethics in day-to-day operations and decisions.Supervisory ResponsibilitiesThis role does not have direct reports but is expected to work in partnership with, and support, our commercial and operational management teams. QualificationsTo perform this position successfully, an individual must be an experienced quality professional with considerable industry experience and relationships. The requirements listed below are representative of the knowledge, skill, and/or ability required. NOTE:This position requires access to export-controlled commodities, technical data, technology, software, and services.U.S. citizenship, U.S. legal permanent resident status, protected person status under 8 U.S.C. § 1324b(a)(3), or U.S. Government export authorization is required. Any offer of employment is contingent upon the employer obtaining the necessary export authorization, including, if required, an export license from the U.S. Department of Commerce’s Bureau of Industry and Security, the U.S. Department of State’s Directorate of Defense Trade Controls, or other applicable government agency. Education and/or Experience• 5-10 years’ experience with clear evidence of building and leading successful teams• Bachelor’s degree (or equivalent qualifications and experience) in a relevant scientific or engineering discipline• Advanced knowledge of quality system requirements related to clinical and medical device testing services• Expertise and knowledge of ISO/IEC 17025 requirements• Strong problem-solving skills with in-depth Root Cause Analysis experience• Highly proficient in reviewing, analyzing and charting quality KPI’s and for presentation to management• Effective organizational and time management skills with the ability to multi-task and prioritize assignments or projects as required• Excellent communication skills, with the ability to represent Clinimark to clients, industry bodies and regulators in a positive and professional manner• Ability to develop effective solutions for complex problems and support clients with their testing programs at a high level• Ability to collaborate effectively in a dynamic, cross-functional matrix environment, effectively influencing colleagues, setting clear expectations, establishing accountability, monitoring progress and achieving agreed strategic goals• Ability to quickly gain the trust and respect of colleagues, clients and senior leadership within ClinimarkLanguage SkillsAbility to read and interpret documents such test procedures and customer testing specifications, including technical drawings.Ability to write routine reports and correspondence to a high standard. Ability to speak effectively before groups of customers or employees of organization. Mathematical SkillsAbility to calculate figures and interpret test results. Ability to apply concepts of basic algebra and geometry. Reasoning AbilityAbility to solve complex Quality and technical related problems. Ability to interpret a variety of instructions, drawings, data and details furnished in written, oral, diagram, or schedule form. Certificates, Licenses, Registrations• Must have valid Driver’s License, with an acceptable driving record under Element’s policy.Physical Demands• Frequency of required physical force: Minimal (low). • Lifting requirements: lifting 5 lbs. sporadicallyOther Skills and Abilities• Experience in interpreting testing procedures and requirements. • Proficiency in Microsoft Applications (Word, Excel)• Availability, flexibility, and maturity to represent the company at industry events and in customers meetings. • Ability to remain calm when faced with mounting pressure related to deadlines and multiple priorities.• Well-developed oral and written communication skills to meet a variety of communication needs. Good interpersonal skills that foster open upward and downward communication built on mutual respect. • Ability to interface with accreditation bodies, customers and industry networks. • Ability to travel up to 50% of the time; overnight travel may be required. Key Behaviors• Leadership• Ability to influence• Passion for Quality Management related to pharmaceutical, medical device and antimicrobial testing and related activities• Managing vision and purpose• Managerial courage• Organizational agility• Drive for results• Works successfully with multiple stakeholdersThis job description reflects an assignment of essential functions, it does not prescribe or restrict the tasks that may be assigned.Other duties and tasks may be assigned to this job at the Company’s discretion. Powered by JazzHRExpected salary:Location: Louisville, COJob date: Mon, 12 Sep 2022 05:34:05 GMTApply for the job now! Apply tot his job