Danaher Corporation Quality Systems Manager in Ames, Iowa
The primary role of this position is to provide leadership, direction and hands on involvement in the implementation of an FDA compliant Quality System, continuous Quality Improvement Plans, and Six Sigma initiatives in support of strategic and policy deployment objectives. FDA responsibilities and requirements are for facilities with FDA regulated products. Provides leadership to QA/QE Team and collaborates with the Site Leadership Team to drive change and make continuous improvements.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Manage, train and direct staff in the QA/QE department.
Implement and sustain an FDA, MDSAP, ISO13485 and ISO 9001, compliant quality system including GM and, Design Controls.
Implement and maintain the Quality improvement process including establishing multiyear targets for achieving the company’s strategic quality objectives.
Drive the development of quality related policy deployment objectives and action plans.
Provide recommendations for the identification and selection of quality improvement projects.
Ensure the promotion of awareness of regulatory requirements throughout the organization to any employees/stakeholders involved with the regulated products
Lead quality improvement project and kaizen teams to deliver results.
Monitor analyze and report effectiveness of quality system.
Monitor and report on quality metrics and progress toward quality goals including internal, incoming, and external quality and complaint handling process.
Track, analyze and resolve customer quality problems via Global Customer Says.
Analyze internal quality defect data to define and resolve root causes.
Assist Purchasing in developing and maintaining supplier quality objectives, resolving supplier quality issues.
Provide “expert” level knowledge, training and consulting in six-sigma, design for six sigma and general quality improvement tools.
Lead process validation program, expert knowledge in IQ, OQ, PQ and equipment cleaning studies
Drive process control and capability of all processes, ensure culture of sustainment
Recommend test and inspection equipment as required to achieve quality goals.
Works with new product development teams on Design for Six Sigma and Design for Manufacturability aimed at improving product quality and reliability.
Manage key quality processes and functions in Ames Operations: Document Control, New Item Implementation, Nonconforming Material and Deviation Control, ECO Control, Customer Complaints
Manage, train and direct staff in the QA/QE department.
Other Non-Essential Functions:
Support development and training of problem-solving techniques
Other duties as assigned.
The ideal candidate is a talented professional who can develop talent, foster innovation and deliver results.
Bachelors (or higher) degree in Engineering/Science, preferable in chemical engineering, chemistry and/or technical area. (Or equivalent Experience)
Formal training in quality planning, tools and analysis.
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.
Experience is required with FDA-compliant design control, change control, process control and quality system management related to medical devices for facilities with FDA regulated products
5 years-experience in a development, manufacturing and/or quality environment including experience in leading cross-functional teams.
Certification in or willingness and ability to complete Black Belt Six Sigma Training.
Experience in a regulated industry is preferred; FDA, EPA, DOT and OSHA
Certification in or willingness and ability to complete: CQE and CQA
Working knowledge of various manufacturing processes.
Proficient computer skills (word processing, spreadsheets, graphics, statistical tools).
Demonstrated ability to grow and develop a team of direct reports.
Must be able to set and attain goals and initiate action to resolve problems and improve products and processes.
Must be able to provide concise executive summaries of quality issues, changes needed or made, results delivered.
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.
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.
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.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.
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