Agile Enterprise Solutions Inc→

Manufacturing Engineer at Agile Enterprise Solutions Inc in Lompoc, CA

Mid LevelOn-siteFull-timeLompoc, CA

Skills

fda 21 cfr part 820fda 21 cfr part 11iso 13485canadian medical device regulationsaustralian therapeutics goods administration regulationsregulatory submissions (ide, 510(k))ms wordms excelms powerpointorganizational skillsleadershipreasoningjudgmentinterpersonal skillscommunicationflexibilityability to work under pressureattention to detail

Job Description

Company Description

Den-Mat Holdings LLC, a global aesthetic dental industry leader since 1974, is advancing the aesthetic dentistry career landscape. We are creating innovative breakthroughs in the science of cosmetic dentistry. Both patients and professionals like what they see! DenMat employs approximately 450 people around the United States and is headquartered in beautiful Lompoc, California. The company owns or has exclusive licenses covering more than 100 patents, including our premier product-LUMINEERS.

Job Description

Required Skills

· Knowledge of FDA’s 21 CFR Part 820 (Quality System Regulation), and 21 CFR Part 11 (Electronic Records; Electronic Signatures). ISO 13485 Medical Device Directive, and the Canadian Medical Device Regulations, and the Australian Therapeutics Goods Administration regulations (as applicable) at an advanced level.

· Knowledge of regulatory submissions (IDE, 510(k), etc.).

· Ability to develop effective quality systems and regulatory strategies and programs.

· Ability to demonstrate excellent organizational, leadership, reasoning, judgment, and interpersonal skills.

· Ability to establish and maintain moderately complex documentation systems.

· Ability to communicate effectively, orally and in writing, with many levels of employees of various disciplines within various departments, and all other internal and external contacts.

· Ability to be flexible in changing daily workload priorities, as directed.

· Ability to maintain accuracy, consistency, and quality in a fast-paced, multi-task environment.

· Ability to coordinate and implement multiple projects.

· Ability to function in a controlled environment regulated by FDA and safeguard restricted, confidential, private or personal information or data.

· Ability to travel, including overnight stays.

· Ability to administer a budget.

· Ability to work under pressure against deadlines and within budget.

· Ability to use MSWord, Excel, and PowerPoint and various office machines such as personal computer, FAX, copier and telephone.

Qualifications

Bachelor's Degree

Additional Information

All your information will be kept confidential according to EEO guidelines.