Quality/Regulatory Engineer

Job DescriptionJob 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 - $70-85k+

Direct hire opportunity!!

Please reply with resume for immediate consideration!!

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)

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

Company DescriptionAt APS we're your down-to-earth, hometown staffing team. We live here. We work here. We understand the business climate. And we know how to connect qualified and reliable talent with the Western New York companies that need them.

When APS was established in Buffalo, NY in 1998, our firm initially focused solely on staffing light industrial positions. Over time, our reputation for quality placements grew, and thus so did the demand for our services. As a result, we expanded our services to include staffing for skilled trades, administrative, it/technical, engineering, and managerial positions.

Our branch is located in Kenmore, and services a wide area within Buffalo and surrounding areas throughout the North and South Towns.Company DescriptionAt APS we're your down-to-earth, hometown staffing team. We live here. We work here. We understand the business climate. And we know how to connect qualified and reliable talent with the Western New York companies that need them. \r\n\r\nWhen APS was established in Buffalo, NY in 1998, our firm initially focused solely on staffing light industrial positions. Over time, our reputation for quality placements grew, and thus so did the demand for our services. As a result, we expanded our services to include staffing for skilled trades, administrative, it/technical, engineering, and managerial positions.\r\n\r\nOur branch is located in Kenmore, and services a wide area within Buffalo and surrounding areas throughout the North and South Towns.