Oakworks, Inc. Logo

Oakworks, Inc.

Quality Assurance Regulatory Affairs Project Specialist

Posted Yesterday
Be an Early Applicant
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

18 Minutes Ago
In-Office or Remote
United States
Senior level
Senior level
Big Data • Information Technology • Software • Analytics • Energy
Provide implementation, configuration, training, and support for SBS Substation Design products. Gather requirements, run demos and pilots, develop documentation and training content, manage support tickets, design and test product enhancements, and collaborate with customers and internal teams. Travel to customer sites and industry events as required.
Top Skills: Admin ToolkitAutodesk Autocad ElectricalAutodesk Autocad Map 3DAutodesk Civil 3DAutodesk InventorAutodesk RevitAutodesk VaultBim Substation DesignerInex (Inventor Export)Physical For AutocadPhysical For InventorSbs Protection & Control
3 Hours Ago
Remote or Hybrid
75K-105K Annually
Senior level
75K-105K Annually
Senior level
Cloud • Insurance • Payments • Software • Business Intelligence • App development • Big Data Analytics
The Manager of Customer Support will lead the team, manage escalated cases, drive operational excellence, and coach team members to improve customer outcomes.
Top Skills: ConfluenceJIRASalesforce Service Cloud
3 Hours Ago
Remote or Hybrid
200K-235K Annually
Senior level
200K-235K Annually
Senior level
AdTech • Cloud • Digital Media • Information Technology • News + Entertainment • App development
Serve as the finance and strategic partner to the CIO & EVP Technical Operations, leading budgeting, forecasting, reporting, strategic analysis, workforce and vendor insights across global Tech Ops. Own finance processes, build tools for capital and operational insights, lead a team of six, and drive alignment with business leaders and finance peers.

What you need to know about the Boston Tech Scene

Boston is a powerhouse for technology innovation thanks to world-class research universities like MIT and Harvard and a robust pipeline of venture capital investment. Host to the first telephone call and one of the first general-purpose computers ever put into use, Boston is now a hub for biotechnology, robotics and artificial intelligence — though it’s also home to several B2B software giants. So it’s no surprise that the city consistently ranks among the greatest startup ecosystems in the world.

Key Facts About Boston Tech

  • Number of Tech Workers: 269,000; 9.4% of overall workforce (2024 CompTIA survey)
  • Major Tech Employers: Thermo Fisher Scientific, Toast, Klaviyo, HubSpot, DraftKings
  • Key Industries: Artificial intelligence, biotechnology, robotics, software, aerospace
  • Funding Landscape: $15.7 billion in venture capital funding in 2024 (Pitchbook)
  • Notable Investors: Summit Partners, Volition Capital, Bain Capital Ventures, MassVentures, Highland Capital Partners
  • Research Centers and Universities: MIT, Harvard University, Boston College, Tufts University, Boston University, Northeastern University, Smithsonian Astrophysical Observatory, National Bureau of Economic Research, Broad Institute, Lowell Center for Space Science & Technology, National Emerging Infectious Diseases Laboratories

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account