Quality Systems Manager - Hach - Loveland, CO at Loveland

Job Description

Purpose of Position:

The primary role of this position to provide leadership, direction and hands on involvement regarding quality processes, structures, and systems that help drive continuous improvement in support of strategic and policy deployment objectives. The Quality Systems Manager is responsible for driving compliance to our quality registration requirements and ensuring optimal value of the QMS to the business.

Essential Functions:

• Serves as ISO Management Representative in coordinating support and maintenance of our ISO quality systems.
• Leads assessment program to ensure QMS is meeting requirements AND adding value to all functions of the business.
• Develops, deploys, and trains changes to the QMS.
• Leads efforts to ensure compliance to FDA GMP requirements as required for select registered products.
• Monitors and reports on QMS metrics and progress toward continuous improvement goals.
• Provides input and recommendations for the identification and selection of improvement projects. Acts as a spokesperson for quality initiatives to generate understanding and support.
• Assists in the development of action plans in support of quality related policy deployment objectives and improvement projects.
• Coordinates and/or facilitates improvement project teams.
• Assists management and teams in selecting quality measures and setting up quality reporting systems.

Other Non Essential Functions:

• Other duties as assigned.

Job Requirements

Education, Background and Skill Requirements

• Bachelors (or higher) degree in a technical discipline preferred.
• 8-10 years experience in a development, manufacturing or quality environment including experience in leading cross-functional teams.
• Formal training in quality planning, tools and analysis ASQ CMQ/CQE/CQA/CQT
• Successful implementation and continuous improvement of multi-site Quality Management Systems ISO 9001, ISO 17025, ISO 14001.
• Working knowledge of FDA-compliant design control, change control, process control and good manufacturing practices (GMP) and quality systems (QS) related to regulated medical devices.
• In-depth knowledge of quality principles and technical tools (problem analysis, statistical tools, design of experiments, design for six sigma, control charts and other quality methodologies) with the ability to train and provide consultation.
• Good computer skills (word processing, spreadsheets, graphics, statistical tools).
• Must be able to set and attain goals and initiate action to resolve problems and improve business performance.
• Must be able clearly communicate to various levels of the organization quality issues, changes needed or made, and results delivered.

Environment: Office

Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally required to reach with hands and arms. The employee is constantly required to sit. The employee may occasionally squat, turn/twist, or reach. The employee is constantly using hands to: finger, handle, feel or operate objects, and computer keyboards. The employee is occasionally required to walk, stand, climb, balance, stoop, bend, kneel, crouch or crawl, and talk, hear, and smell.

The employee must occasionally lift, carry, push or pull up to 20 pounds.

Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The work environment consists of an indoor, work or home office environment with good ventilation, adequate lighting, and low noise levels.

The duties listed in job descriptions are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.

PRE-EMPLOYMENT TESTING

External hiring into this position is contingent upon the successful completion of a pre-employment drug screen and background check and possible credit history review.

Hach is an Equal Opportunity Employer

The purpose of this description is to assist in ADA compliance and is not intended for other purposes such as collective bargaining, or compensation.

Country: USA, State: Colorado, City: Loveland, Company: Danaher.