Oakworks, Inc. Logo

Oakworks, Inc.

Quality Assurance Regulatory Affairs Project Specialist

Posted 8 Days Ago
Remote
Hiring Remotely in USA
Senior level
Remote
Hiring Remotely in USA
Senior level
Hands-on role owning regulatory requirements and document control for medical devices. Maintain QMS compliance (FDA 21CFR 820, ISO 13485, ISO 14971), perform trending analysis, manage quality projects, and use quality system software (QT9 preferred).
The summary above was generated by AI

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 

Similar Jobs

An Hour Ago
Remote or Hybrid
Senior level
Senior level
Artificial Intelligence • Cloud • HR Tech • Information Technology • Productivity • Software • Automation
Lead and coach regional sales leaders and direct reps to drive new business and revenue growth. Own territory and quota planning, forecasting, pipeline management, C-level engagement, partner collaboration, and cross-functional alignment. Recruit and develop talent, support field teams to close deals, and retain/expand customer accounts while executing strategic sales initiatives to meet quarterly and annual targets.
Top Skills: AICRMServicenow
An Hour Ago
Remote or Hybrid
148K-230K Annually
Expert/Leader
148K-230K Annually
Expert/Leader
Artificial Intelligence • Cloud • HR Tech • Information Technology • Productivity • Software • Automation
Lead technical architecture and platform strategy for ServiceNow implementations across federal customers. Advise executives and engineering teams on instance strategy, integrations, governance, cloud application design, and technical debt reduction. Scope engagements, support sales, contribute leading practices, mentor others, and ensure long-term platform health and adoption.
Top Skills: AIAPIsCloudIntegrationsServicenow
An Hour Ago
In-Office or Remote
118K-232K Annually
Senior level
118K-232K Annually
Senior level
Aerospace • Information Technology • Software • Cybersecurity • Design • Defense • Manufacturing
Develop, deploy, and maintain RTOS and Linux (Yocto) configurations and hypervisor (Xen/KVM) integrations for safety-critical systems. Lead technical design, testing, performance analysis, and verification activities. Provide subject-matter expertise, tooling/process improvements, and support software lifecycle from requirements through deployment.
Top Skills: Arinc 653BazelBootloadersBuildrootCC++ClangDevice DriversDockerGccGitGitlab CiKvmLinux KernelPodmanPosixPythonRtosRustXenYoctoYocto Linux

What you need to know about the NYC Tech Scene

As the undisputed financial capital of the world, New York City is an epicenter of startup funding activity. The city has a thriving fintech scene and is a major player in verticals ranging from AI to biotech, cybersecurity and digital media. It also has universities like NYU, Columbia and Cornell Tech attracting students and researchers from across the globe, providing the ecosystem with a constant influx of world-class talent. And its East Coast location and three international airports make it a perfect spot for European companies establishing a foothold in the United States.

Key Facts About NYC Tech

  • Number of Tech Workers: 549,200; 6% of overall workforce (2024 CompTIA survey)
  • Major Tech Employers: Capgemini, Bloomberg, IBM, Spotify
  • Key Industries: Artificial intelligence, Fintech
  • Funding Landscape: $25.5 billion in venture capital funding in 2024 (Pitchbook)
  • Notable Investors: Greycroft, Thrive Capital, Union Square Ventures, FirstMark Capital, Tiger Global Management, Tribeca Venture Partners, Insight Partners, Two Sigma Ventures
  • Research Centers and Universities: Columbia University, New York University, Fordham University, CUNY, AI Now Institute, Flatiron Institute, C.N. Yang Institute for Theoretical Physics, NASA Space Radiation Laboratory

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account