Posted in Other 13 days ago.
Location: Littleton, Colorado
Aspen Seating and Ride Designs offers you the opportunity to truly be part of a team that changes people’s lives. Since 1998, Aspen Seating and Ride Design has been providing customized wheelchair seating for all levels of users, from Para-Olympic athletes to everyday people. Aspen Seating is committed to helping those who are non-ambulatory get their lives back through constant research and development, consistency of current products and customer service.
If you are looking to feel good about your work and be able to physically see the difference you make, then we are the place for you. Our ever-growing brand has an immediate opening for a Quality & Regulatory Compliance Engineer.
Responsible for implementation of Quality Systems elements in accordance with FDA Quality Systems Regulations and ISO 13485 standards. Responsible for providing direct support of product and manufacturing engineering activities including manufacturing process capability and supply chain quality management. Performs Regulatory activities to support legal/regulatory laws as appropriate for a medical device manufacturer in North America. Provides Regulatory oversight/expertise on all projects, as needed. Ensures timely investigation and response for product complaints and injury reports working collaboratively with other members of the organization to initiate and participate in investigations and corrective actions.
Required Skills, Knowledge, and Experience:
Bachelor of Science in an engineering discipline or equivalent experience. Mechanical, Manufacturing, Process or Quality Engineering Degree a plus.
two plus years of relevant experience in manufacturing or quality environment required. Medical devices or wheelchair/mobility products experience a strong plus.
Knowledge of ISO 13485, 21 CFR 820, and ISO 14971 preferred.
Certified Quality Engineer and/or Six Sigma Black Belt Certification preferred.
Strong working knowledge of computer database systems, Microsoft applications, PC, and various software programs required.
Strong aptitude for problem solving, root cause analyses, and statistical analyses. Process/product validation experience.
Experience with Quality Risk Assessment tools such as HARMs, FMEA, MRB, CAPA, required.
Capable to present data (presentations) to management teams and train co-workers as needed.
Must have ability to properly interpret Engineering drawings and clearly present that information to others.
Ability to interface with a variety of associates with exceptional communication skills.
Must have ability to present data clearly and concisely.
Physical Requirements:
The physical demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Deductive Reasoning — The ability to apply general rules to specific problems to produce answers that make sense.
Fluency of Ideas — The ability to come up with a number of ideas about a topic.
Inductive Reasoning — The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).
Information Ordering — The ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, mathematical operations).
Lifting/ Carry Weight - Must frequently move and lift up to 10 lbs. and occasionally lift and/or move up to 40 lbs.
Mathematical Reasoning — The ability to choose the right mathematical methods or formulas to solve a problem.
Oral Comprehension — The ability to listen to and understand information and ideas presented through spoken words and sentences.
Oral Expression — The ability to communicate information and ideas in speaking so others will understand.
Problem Sensitivity — The ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing there is a problem.
Selective Attention — The ability to concentrate on a task over a period of time without being distracted.
Speech Clarity — The ability to speak clearly so others can understand you.
Speech Recognition — The ability to identify and understand the speech of another person.
Written Comprehension — The ability to read and understand information and ideas presented in writing.
Written Expression — The ability to communicate information and ideas in writing so others will understand.
PI239776827
Salary: $58,780.00
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Oldcastle
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Oldcastle
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Oldcastle
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