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Menlo Park, California, United States · On-site
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South San Francisco, California, United States · Hybrid
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Berkeley, California, United States · On-site
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Tempe, Arizona, United States · On-site
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Long Beach, California, United States · On-site
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Santa Clara, California, United States · On-site
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Mountain View, California, United States · On-site
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San Diego, California, United States · On-site
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California, United States · Hybrid
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California, United States · On-site
Come join the Sensor Technology Team! We're a multi-disciplinary, problem-solving team developing state-of-the-art sensing solutions and technologies that are central to Apple's products, including the iPhone, iPad, Appl…
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The specialist provides onsite support for quality systems, including implementing and maintaining the quality management system and conducting internal audits. They are responsible for reviewing customer complaints, managing CAPAs, and coordinating calibration and environmental monitoring activities.
Requires a bachelor's degree in a scientific field and 2 to 4 years of related experience, preferably in medical devices. Candidates must have knowledge of FDA GMPs, ISO 13485, and MDSAP regulations.
Objective
Under general direction, will provide onsite support in quality systems activities to assist in meeting company objectives and quality systems requirements.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
Additional Duties and Responsibilities include the following. Other duties may be assigned.
Supervisory Responsibilities
This position has no supervisory responsibilities.
Education and/or Experience
Bachelor’s degree from a four-year college or university in a scientific field and 2 to 4 years related experience. Previous medical device quality experience is desirable.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the described functions.
Language Skills
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to complete forms accurately and write routine notes and documentation. Ability to effectively communicate information in one-on-one situations to other employees of the organization.
Mathematical Skills
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
Computer Skills
Ability to use word processing, spreadsheet, and database applications. Ability to learn various software programs.
Certificates, Licenses, Registrations
None required.
Knowledge, Skills, and Abilities
Knowledge of FDA GMPs, ISO 13485, MDSAP
Knowledge of medical device manufacturing or a related field.
Ability to communicate effectively, orally and in writing, with 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 and accurately perform detail- oriented work.
Ability to work independently and demonstrate strong organizational, follow-through and resolution skills.
Ability to maintain accuracy, consistency and quality in a fast-paced, multi-task environment.
Ability to coordinate and synchronize multiple projects.
Ability to function in a controlled environment under domestic and international regulations and handle extremely confidential data.
Physical Demands and Work Environment
The physical demands and work environment characteristics 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 regularly required to talk; hear; sit; use hands to finger and handle; bend at the waist and/or neck use one or both hands repetitively; use fine manipulation with one or both hands and to reach above or below shoulder level. The employee is occasionally required to stand; walk; twist at the waist or neck use a simple grasp with one or both hands; and lift and/or move up to 50 pounds. Normal 20/20 vision ability (with corrective lenses, if needed) is required by this position. The noise level in the work environment is moderately quiet.
The posted range for this position is $66,037-$90,802 annually which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range including education, prior experience, training, current skills, certifications, location/labor market, internal equity, etc.
Clinician's Choice, A division of DenMat Holdings, offers a complete benefits package, including Medical/Dental/Vision/Rx, Company Paid and Optional Life Insurance, 401(k) with matching contribution, Vacation, Sick Pay 10 paid company Holidays (or Float Days), Bereavement, Jury Duty Pay, Employee Assistance Program and employee discounts.
Clinician's Choice, A division of DenMat Holding participates in E-Verify.
DenMat Holdings, LLC is an Equal Opportunity/Affirmative Action Employer; employment with DenMat is governed on the basis of merit, competence and qualifications and will not be influenced in any manner by race, color, religion, creed, national origin/ethnicity, veteran status, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital status, or any other legally protected status.
Products • Lab • Education
For over 40 years, DenMat has been a leader in high-quality dental products sold directly to dental professionals in the U.S., and through distributors around the world. We manufacture and assemble the majority of our products at our world headquarters located on the beautiful Central Coast of California. Our expansive product portfolio includes: Restoratives, Impressions, Whitening, Oral Hygiene, Instruments, Magnification and Illumination, and Small Equipment. In addition, DenMat Lab offers the well-known Lumineers® and Snap-On Smile® brands that patients ask for by name. DenMat is an AGD PACE certified continuing education provider, currently offering courses on Soft Tissue Management and Minimally Invasive Smile Design in major cities across the country.
Offices: 1017 W. Central Avenue, Lompoc, CA 93436, US
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