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Danaher Corporation Senior Quality Engineer in Ames, Iowa

POSITION SUMMARY:

The primary role of this position is to provide leadership and hands on involvement in the fields of validations, Advance Product Quality Planning (APQP), component qualifications, supplier qualifications for Class I, II medical devices and non-medical devices. The Senior Quality Engineering position shall utilize problem solving techniques to lead equipment/process validations, support APQP, component qualifications and supplier qualifications . Candidates should possess strong interpersonal and communication skills to drive a quality and a continuous improvement culture to further improve the company's products and engagement. This role will be recognized as a technical Quality leader and resource to the organization.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Equipment & Process Validations:

  • Lead global validation program and standardizes policy involving production and process controls.

  • Develop and execute requirements for new processes and continuous improvement initiatives.

  • Manage multi-functional teams to resolve problems, improve processes and develop solutions for safety, quality, productivity and cost improvements.

  • Lead APQP activities for components and supplier processes.

  • Lead component qualifications.

  • Support supplier qualification process with supplier assessments and audits as necessary

  • Complies with U.S. Food and Drug Administration (FDA) regulations, ISO 13485 (if applicable), ISO 9001 and other regulatory requirements, Company policies, operating procedures, and task assignments.

  • Execute process and equipment validations (IQ/OQ/PQ) during acceptance testing for new equipment, new processes and for ongoing manufacturing needs following cGMP requirements.

  • May supervise and/or direct other members of the quality staff to assist them in their assignments and provide them with learning experience.

  • Immersed in diagnosing issues found during the manufacturing process and driving corrective action back to the source through controlled problem-solving disciplines.

  • Perform process characterization and capabilities studies for new equipment and change management.

  • Develops sampling plans and analyzes data utilizing hypothesis testing, design of experiment, normal distribution and process capability tools.

  • Analyze data from various sources to identify trends in quality.

  • Create and review test plans to identify critical control parameters based on statistical data analysis.

  • Establish multi-year targets and plans for achieving strategic quality objectives.

    QUALIFICATIONS:

The ideal candidate is a talented professional who can develop talent, foster innovation and deliver results.

  • Bachelor’s degree in Engineering or Engineering Technology. Master’s preferred.

  • Minimum 5 years of relevant experience in a Quality, validation or Design Assurance position in a Medical Device and/or other highly regulated industry.

  • Minimum 5 years’ experience in decision making role and capacity preferred

  • Expert skills in quality assurance practices, standards and principles. Certified Quality Engineer (ASQ) preferred.

  • Six Sigma project experience, certified Green Belt or Black Belt preferred.

  • In depth knowledge of quality principles, APQP, and Lean Six Sigma with the ability to train and provide consultation.

  • Knowledge of 21 CFR part 820 and ISO 13485:2016 quality systems principles

  • Knowledge of ISO 14971, Risk Management for medical devices

  • Excellent communication and use of collaborative tools

  • Supplier audit/assessment experience for medical device supplier, Certified Quality Auditor (CQA) preferred.

  • Excellent computer skills (word processing, spreadsheets, presentation, project, statistical tools)

  • Working knowledge of various manufacturing processes preferred

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. 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.

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at 202.419.7762 or applyassistance@danaher.com to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.

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