Waters Corporation

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Site Quality Assurance Manager

Site Quality Assurance Manager

Req. # 
7706
Company Name 
Waters Division
Category 
Quality Assurance
Location 
US-CO-Golden
Type 
Regular Full-Time

More information about this job

Company Description

For over 50 years, Waters Corporation has developed innovative analytical science solutions to support customer discoveries, operations, performance, and regulatory compliance. Specifically, the company designs, manufactures, sells, and services high performance liquid chromatography, ultra performance liquid chromatography, and mass spectrometry technology systems and support products primarily in the United States, Europe, Japan, and Asia. Our innovations enable significant advancements within the pharmaceutical, life science, biochemical, industrial, food safety, environmental, academic and government industries. Waters is a publicly traded corporation (NYSE:WAT) with more than 6,500 employees and is represented in over 100 countries around the world.

 

 

Waters Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status. 

Overview

ERA, A Waters Business is the leading Proficiency Standards Company in the United States.  In this role, the Site Quality Assurance Manager will be responsible for the ongoing development, implementation and maintenance of the quality management system which support business needs, which includes compliance to regulatory Systems/Standards in addition to the generation and maintenance of the site quality strategy. The individual will be responsible for the assessment, follow up and implementation of compliance with ISO-9001, ISO/IEC-17025, ISO/IEC-17043 and ISO Guide 34.  In addition, be responsible for the management of Supply Chain Quality. 

 

Development, implementation and monitoring of quality systems to ensure the highest levels of product quality and customer satisfaction while maintaining regulatory and accreditation compliance.

The Site Quality Assurance Manager will be a part of the ERA site leadership team and engage with global quality.

Responsibilities

Quality Program

  • Development, Implementation, communications, and maintenance of Quality Management System and plan to bring Golden’s Quality System and Polices into compliance with the QMS (global QMS) requirements. Promotion of quality achievement and performance improvement throughout the organization. Effectively 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 .

Internal Audits

  • 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 Guide 34, and all applicable regulatory/industry standards. Investigation and resolution of internal audit issues.

Supplier Assessment

  • 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.

Documentation Management / Review

  • Management of the document control process including record retention and retrieval.

ISO Compliance

  • Ensures new regulations impacting the operation are reported effectively 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.

Project Work

  • Ensures Quality representation on major projects.
  • Ensures compliance with ISO Standards:, applicable good documentation practice regulations and company standards.

Quality Metrics

  • Formulation, development, implementation, and management of goals, metrics, objectives, procedures and systems pertaining to Quality. Monitoring performance by gathering 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)

Validation

  • Responsible for the implementation and maintenance of the validation system to ensure that it is accurate, complete and compliant with the requirements of the quality management system / GMP and associated ISO accreditations.

Customer Complaint Management

  • Responsible for the oversight of customer complaint handling and maintenance  of the customer complaint handling system including the implementation and follow up of corrective actions and trending of data.

Quality Management System

  • 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. 

Other tasks include:

  • Quality investigations
  • GDP / Quality awareness and training of plant personnel
  • External Audit Preparation
  • Lean Implementation 

Qualifications

  • BS or equivalent academic qualifications.
  • Minimum 5 years experience within a Chemistry manufacturing lab and strong understanding of ISO-9001, ISO/IEC-17025, ISO/IEC-17043 and ISO Guide 34 and cGMP environment. Previous Management experience of quality management systems required.
  • ISO-9001, ISO/IEC-17025, ISO/IEC-17043 and ISO Guide 34, cGMP , Auditing, Documentation, Computer Literate, Leadership.
  • Good interpersonal and communication skills.
  • Excellent attention to detail. Ability to work on ones own initiative.
  • Demonstrate sound rational judgement. Good report writing and reviewing skills.
  • Good people management skills.
  • Ability to drive and implement a sound Quality Program via communication and coordination with various departments.