Waters
Location
Golden, CO | United States
Job description
The Quality Assurance Manager is responsible for the development, implementation, and monitoring of quality systems to ensure the highest levels of product quality and customer happiness while maintaining regulatory and accreditation compliance.
The position is responsible for the ongoing development, implementation, and maintenance of the quality management system and support of Waters and ERA Business needs which includes compliance with regulatory Systems/Standards in addition to the generation and maintenance of the site quality strategy. Responsible for the assessment, follow up, and implementation of compliance with ISO-9001, ISO/IEC-17025, ISO/IEC-17043, and ISO-1734. Responsible for the management of Supply Chain Quality.
· Development, Implementation, communications, and maintenance of the Quality Management System and plan to bring Golden’s Quality System and Policies into compliance with the QMS (global QMS?) requirements. Promotion of quality achievement and performance improvement throughout the organization. Optimally interact with Production, Customer Service, and Shipping to maintain product and service quality as well as help introduce new products.
Quality Inspection
· Management and oversight of incoming inspection activities, including the maintenance of Purchase Specifications, inspection records etc.
· Management of internal audit process by ensuring efficient and effective auditing and quality management system to ISO-9001, ISO/IEC-17025, ISO/IEC-17043, and ISO Guide1734, and all applicable regulatory/industry standards. Investigation and resolution of internal audit issues.
· Management of the Supplier Assessment system in order to ensure compliance with Waters Corporation, ERA, and all applicable regulatory/industry standards. Investigation and resolution of supplier quality issues and implementation of Supplier Improvement programs.
· Management of the document control process including record retention and retrieval.
· Ensures new regulations impacting the operation are reported successfully to top Management.
· Assessment of ISO compliance.
· Implementation of corrective and preventive actions to ensure compliance of the quality management system with applicable quality and regulatory standards.
· Management of regulatory/external inspections.
· Ensures Quality representation on major projects.
· Ensures compliance with ISO Standards:, applicable good documentation practice regulations and company standards.
· Formulation, development, implementation, and management of goals, metrics, objectives, procedures, and systems pertaining to Quality. Supervising performance by capturing relevant data and producing statistical reports and metrics.
Corrective and Preventive Action / Non-conformance System
· Responsible for the maintenance, administration, and compliance of the corrective/preventive action and non-conformance systems. Using sound Root Cause analysis tools as well as COPQ (Cost of Poor Quality)
· Responsible for the implementation and maintenance of the validation system to ensure that it is accurate, complete, and aligned with the requirements of the quality management system / GMP and associated ISO accreditations.
· Support customer complaint handling including correspondence, investigations, corrective preventive actions, and trending of data
· Management System Representative - Responsible for the Quality Management System including the quality objectives, management review, external audits, continuous improvement etc.
· Responsible for communication with other sites within Waters Corporation on quality issues.
· Responsible for third party audits, both customer and ISO surveillance.
· Evaluate employee performance management, employee development, and support.
· Quality investigations
· GDP / Quality awareness and training of plant personnel
· External Audit Preparation
· Lean Implementation experience
BS degree or equivalent experience preferably in a life science, chemistry or engineering field The general base pay for this position ranges from $104,000-$138,500 per year. Pay is based on several factors including market location, job-related knowledge, skills, and experience. #LI-CB1
Waters Corporation (NYSE: WAT), the world's leading specialty measurement company, has pioneered chromatography, mass spectrometry and thermal analysis innovations serving the life, materials, and food sciences for over 60 years. With approximately 8,000 employees worldwide, Waters operates directly in 35 countries, including 15 manufacturing facilities, with products available in more than 100 countries. Our team focuses on creating business advantages for laboratory-dependent organizations to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality.
Working at Waters enables our employees to unlock the potential of their careers. Our global team is driven by purpose. We strive to be better, learn and improve every day in everything we do. We’re the problem solvers and innovators that aren’t afraid to take risks to transform the world of human health and well-being. We’re all in it together delivering benefit as one to provide the insights needed today in order to solve the challenges of tomorrow.
Diversity and inclusion are fundamental to our core values at Waters Corporation. It is our responsibility to actively implement programs and practices to drive inclusive behavior and increase diversity across the organization. We are united by diversity and thrive on it for the benefit of our employees, our products, our customers and our community. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or protected Veteran status.
# Quality # Audit #ISO #Quality Manager #EnvironmentalJob tags
Salary
