Build Your Future With A Quality Assurance Management for Medical Devices Certificate
The Quality Assurance Management for Medical Devices Certificate Program is designed to prepare students to obtain an entry-level position in quality assurance within the medical device industry. This program provides in-depth instruction on the standards and regulations that govern the development of medical devices.
Topics covered include regulatory agencies and laws pertaining to the medical device industry; introduction to the medical device industry and trends in the field; document control and database management; quality assurance concepts for medical device manufacturing; technical writing; the quality audit process; and employability skills.
NOCE’s Quality Assurance Management for Medical Devices Certificate Program prepares students for entry-level positions as Quality Control Inspectors, Quality Assurance Specialists, Quality Compliance Specialists, Quality Systems Auditors, Quality Associates, Data Entry Associates, and Manufacturing Assemblers/Operators within the medical device industry.
Upon completion of the program students will be able to:
- Discuss laws covering the regulation of medical devices
- Understand the U.S. regulatory requirements necessary for the clearance, approval, or release of medical devices
- Perform medical device quality assurance reviews and approvals
- Enact change control measures
- Identify the methods and tools used for control quality
- Discuss the concepts of production and process controls as they relate to product quality
- Write technical correspondences
- Practice and complete the audit process
Additional Eligibility Requirements Include:
- Must be 18 years or older to enroll
- Must complete an NOCE Admissions Application
- Must complete an in-person Assessment and online Orientation at least 24 hours prior to registering
- Should have basic English reading, writing, and speaking skills and/or be at an ESL intermediate-low level (recommended)
- Should have basic math skills (recommended)
Frequently Asked Questions
Upon completion of this program, students will be awarded a certificate.
All NOCE Quality Assurance Certificate courses are tuition-free. However, students are responsible for covering the cost of textbooks, course supplies, and a parking pass.
The program can be completed in as little as 8 months.
Average salary per year in this field ranges from $32,000 to $50,000 per year.
Entry-level Quality Assurance/Control Associates have career growth opportunities in the following positions:
- Quality Control Technician
- Documentation Associate
- Regulatory Associate
- Associate Quality Engineer
|Number of Jobs in 2016||7,802|
|2016-26 Job Growth||11% (Much Faster Than Average)|
|Entry-Level Pay in 2016||$32,619/ Annual, $15.68/ Hour|
|Median Pay in 2016||$50,018/ Annual, $24.05/ Hour|
Degrees & Certificates
Quality Assurance Management for Medical Devices Certificate
For students who like conducting tests, interpreting results, and performing inspections, the Quality Assurance Management for Medical Devices Certificate Program at North Orange Continuing Education (NOCE) is the first step to a career in the medical device industry.
The medical devices industry sector is growing and is regulated by strict and evolving FDA standards that require trained employees to understand and enforce quality control measures. Quality Assurance and Control Specialists develop procedures to ensure compliance with regulatory requirements, review and evaluate testing protocols, conduct quality systems audits, and implement timely follow-up and corrective actions.
It is recommended that students in this field have basic math skills, basic English reading, writing, and speaking skills and/or be at an ESL intermediate-low level.
People in this career often have these skills:
- Reading Comprehension – Reading work-related information
- Problem Solving – Noticing a problem and figuring out the best way to solve it
- Active Listening – Listening to others, not interrupting, and asking good questions.
People in this career need skills such as:
- Attention to Detail
There are many benefits in completing the QA program. This program prepares incumbent workers for promotional opportunities and students will become part of a growing industry that requires skilled workers at all levels. Quality Assurance students also will learn how to market themselves through embedded curriculum on employability skills.
Quality Assurance Management for Medical Devices graduates have careers that often grow into the following positions:
- Quality Assurance Director
- Quality Assurance Lead
- Quality Assurance Manager
- Quality Assurance Specialist