If you have a holistic team approach to improve quality, we want to develop you!
Oakworks has an opportunity if you have regulatory and quality assurance experience in a medical device environment.
This role is analytical and hands-on and is responsible for our regulatory requirements and document control processes.
WHAT WE PROVIDE:
A platform in providing health and wellness solutions
Friendly, fun, clean and a safe work environment
Competitive wage and benefits
Ability for growth
Being a member of an innovative company
About Oakworks:
Oakworks is a family owned and run company for over 40 years that produces world class medical and spa equipment in our modern 91,000 sq ft building. You will be helping to build a wide array of products with a great team of people. We offer a 401k plan, paid time off, 9 paid holidays and opportunities for advancement. Oakworks does not only focus on the quality of our products but also cares about our employees. Oakworks is proudly promoting health awareness through different activities within the company. We strive on being an employee centered workplace and hold multiple fun events to show our appreciation.
Qualifications
WHAT WE REQUIRE:
Must have Bachelor’s Degree or equivalent ideally in sciences, engineering, or another relevant scientific discipline. 5 years of professional experience in QARA; quality management systems relating to medical devices (FDA 21CFR 820, ISO 13485, ISO 14971.
Advanced computer skills, trending analysis, project and Quality System software experience (QT9 preferred) are required.
WHO WE ARE:
Oakworks brings high quality, innovative products to the health and wellness market. As a leading manufacturer of medical, spa, and massage tables we’re proud to support customer and employee wellness. Since its beginning in 1978, Oakworks has maintained a commitment toward environmental conservation and is conveniently located in New Freedom, PA between York, PA and Baltimore, MD. We invite you to join our team!
Remote roles are eligible to work in the following states: PA, FL, GA, SC, DE
Please note we are not offering relocation assistance.
Equal Opportunity Employer and M/F/Vets/Disability
Skills Required
- Bachelor's degree or equivalent in sciences, engineering, or related discipline
- 5 years professional experience in Quality Assurance Regulatory Affairs (QARA) for medical devices
- Knowledge and application of FDA 21CFR 820
- Knowledge and application of ISO 13485
- Knowledge and application of ISO 14971
- Advanced computer skills and trending analysis
- Project and Quality System software experience
- Experience with QT9 quality management software
- Experience with regulatory document control processes
What We Do
Oakworks, Inc. is a global brand specializing in the manufacturing of medical tables, spa tables, massage tables, and accessories, with over 45 years of innovation. They focus on producing safe, durable, and ergonomic wellness equipment.
