Quality & Regulatory Engineer

North Tonawanda, NY 14120

Posted: 01/10/2025 Industry: Professional Pay Rate: $70-85k Salary

Job Description

Manufacturing company in North Tonawanda, NY specializing in oxygen and nitrogen generating equipment and technology looking for a Quality/Regulatory Engineer to join their team!!

1st shift hours

Pay varies based on experience - $70-80k+

Direct hire opportunity!!

Please reply with resume for immediate consideration!!

 

JOB DUTIES:

  • Review design history technical files for conformance to applicable requirements and regulatory standards.
  • Review design changes to ensure documentation includes necessary justifications, validation and verification updates, risk assessment, etc.
  • Review all applicable design documentation (verification & validation protocols/reports, DRTM, FMEAs, design outputs, etc.)
  • Support manufacturing line, investigate and address quality issues.
  • Conduct internal, vendor and process audits
  • Interface with suppliers to resolve quality issues
  • Responsible for document change requests, CAPAs, NCRs, temporary deviations, Equipment management, and defining & maintaining training of personnel on all aspects of the Quality System and regulatory standards

Job Requirements

REQUIREMENTS:

  • 5+ years of Quality Engineering experience, preferably with technical knowledge and experience in Quality Assurance and/or regulatory functions in the medical device industry
  • Bachelor’s Degree in Mechanical or Biomedical Engineering or related engineering or scientific disciplines.
  • ISO 9001, ISO 13485 and cGMP/21 CFR 820 experience required
  • Strong self-starter, effective team player
  • Effective oral, written and presentation skills
  • Knowledge of Microsoft Office Suite (Word, Excel, PowerPoint, Teams)

Meet Your Recruiter

Eric Gunderson
Recruiting Coordinator

Eric received his undergraduate degree from University at Buffalo before beginning his career in the staffing industry. After two years of recruiting experience in the Rochester area, he joined the Kenmore branch of APS and has been in this role for over a year. Eric is a Certified Staffing Professional who specializes in the recruitment and placement of individuals within skilled trades, manufacturing, industrial, and administrative roles for a wide variety of companies in Western NY. His prior experience in landscaping, skilled trades, and heavy labor allows him to identify with applicants and potential candidates in order to match them up best with opportunities for our clients. Timeliness and feedback are very essential for speed to market recruitment, and this is something that Eric pushes for on a daily basis for both applicants and clients.
Apply Online
Apply with LinkedIn Apply with Facebook Apply with X

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

About North Tonawanda, NY

Ready to embark on a new career adventure in North Tonawanda, New York? This charming city nestled in Niagara County offers a wealth of job opportunities and a vibrant community perfect for both professional growth and quality of life. Imagine working in a city renowned for its stunning waterfront views, historic landmarks like the North Tonawanda History Museum, and its close proximity to the iconic Niagara Falls. With a rich arts scene, including the Carnegie Art Center and the Riviera Theatre, as well as a variety of dining options showcasing western New York's beloved Buffalo wings, there's something for everyone here. Join us in exploring job opportunities in this enchanting region and take the first step towards a rewarding career in North Tonawanda!