Quality Systems Engineer

POSITION SUMMARY: The primary role of this position to provide hands on involvement regarding quality systems, quality control and continuous improvement in support of strategic and policy deployment objectives.ESSENTIAL DUTIES AND RESPONSIBILITIES:Provides input and recommendations for the identification and selection of quality system improvement projects.Monitors quality metrics and progress toward quality system goals including nonconforming material, internal audits, CAPAs, SCARs, Document Control, Training and CalibrationInitiates and leads problem solving activities when quality goals are not metImplements process and software validation policy and procedures. Writes protocols, facilitates completion of validation protocol procedures, performs data analysis, and writes reports. Fulfills QA subject matter expert role for all functional areas.Maintains Process and Software Validation Master Plans and product risk analysis.Assists in new product development activities and supports design change activities following design control requirements and internal procedures, including developing test methods, test method validations, risk management activities (FMEA's), process validations (IQ, OQ, PQ) .Conducts root cause and corrective action investigations for quality failures, including those occurring in supplier and in-house processes.Supports all facets of the internal audit system including scheduling, auditing, reporting, and corrective actions.Continually improves quality system by evaluation and improvement to inspection and test methods, sampling plans, and process control plans based on quality data sources (e.g. NCNs).Completion of the above duties and responsibilities will include the use of Gage R Studies, Design of Experiments, Failure Mode and Effects Analysis, Statistical Process Control, the determination of Operating Characteristics for Sampling Plans, and general statistical analysis of data.Prepares and conducts training sessions and presentations as required to complete the above duties and responsibilities.Maintains a professional working relationship with internal and external customers and support staff.Other Non Essential Functions:Other duties as assigned.QUALIFICATIONS:Bachelors (or higher) degree in a technical discipline preferred (Physical Sciences or Engineering).Formal training in quality planning, tools and analysis.QMS experience with ISO9001 or ISO13485 or FDA21CFR820In depth knowledge of quality principles and technical tools (problem analysis, statistical tools, controlcharts and other quality methodologies.Has completed or is willing and able to complete Six Sigma Training.3-5 years' experience in a development, manufacturing or quality environment including experience in leading cross-functional teams.Working knowledge of various manufacturing processes preferred.Computer skills (word processing, spreadsheets, graphics, statistical tools).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.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.Employees will berequiredto wear the proper Personal Protective Equipment (PPE) which may include: eye, hearing and respiratory protection, protective smock, steel toe shoes, gloves, hard hats, or face shields. Contact lenses may not be allowed in some areas.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. The purpose of this description is to assist in ADA compliance and is not intended for other purposes such as collective bargaining, or compensation.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.The hourly rate or salary range for this role is $56,600-$77,800. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range and this range is only applicable for jobs to be performed in Colorado. This range may be modified in the future.This job is also eligible for bonus pay.We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.You can apply for this role through the Careers Page at https://jobs.danaher.com/global/en/ (or through the Workday "Find Jobs" function if you are a current employee)Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.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.

Didn't find what you're looking for? Search again!

I'm looking for

in category

Advertising Legal Government & Protective Services PR / Public Relations Engineering Human Resources Accounting, Auditing Executive IT / Software / Systems Design, Graphic Design & CAD Administration, Clerical Education / Teaching ALL

within

5 Miles of Loveland 10 Miles of Loveland 25 Miles of Loveland 50 Miles of Loveland 100 Miles of Loveland 250 Miles of Loveland

• Let loveland recruiters find you. Post your resume for free!
• Get loveland Other jobs via email.


• View more Loveland Other jobs