Quality Assurance and Regulatory Affairs Specialist

EMED Technologies Corporation; New York (NY); On-site; USD 85,000 - 110,000; Full time

Job summary

EMED Technologies Corporation is seeking a Quality Assurance and Regulatory Affairs Specialist to support the company’s QMS and ensure compliance with applicable regulations. You will work closely with CA/QA/RA leadership and cross-functional teams to maintain documentation, CAPA, and audit readiness.

The role emphasizes document control, CAPA investigations, handling nonconforming product, customer complaints, and quality metrics reporting, with opportunities to engage in internal and supplier

Qualifications

• Bachelor's degree in Science, Engineering or related field.
• Minimum of 3 years of experience in Quality Assurance in pharmaceutical and/or medical device industries.
• Knowledge of MS Office Suite (Excel, Word, Outlook).
• Excellent interpersonal skills, ability to meet deadlines, manage priorities and work well under pressure.

Responsibilities

• Administration of Document Control function, including document ID issuance, revision control, coordination of review and approval, communication of implementation tasks, and maintenance of all records.
• Lead/assist with CAPA investigations, plan development and implementation of corrective actions, author CAPA reports, and ensure completion and accuracy of all associated Quality records.
• Support nonconforming product handling and disposition assessments and manage all records.
• Coordinate the efficient handling and resolution of Customer Complaints, working with contract manufacturer sites and other EMED departments, and manage all records.
• Perform reporting and trending on Quality metrics to ensure an oversight of the compliance landscape for the site.
• Support external audits/inspections with audit readiness preparations, back-room support and response writing to non-conformances.
• May serve as an Internal/Supplier Auditor and conduct audits per schedule
• Write new and revise existing QMS standard operating procedures as directed.
• Review, approve, and maintain device history record files.
• Identify, initiate, and lead process and compliance improvement as requested.
• Interface with other EMED departments such as Engineering, Operations, Customer Service, and Regulatory Affairs as necessary to ensure success for assigned responsibilities.
• Support various Quality Assurance activities as assigned under minimal supervision/instruction.
• Assist with Regulatory Affairs tasks as assigned
• Ensure that all Quality Assurance related tasks and responsibilities defined in EMED Quality Management System Documentation are performed, as defined.

Skills

Interpersonal skills

Time management

Self-directed work

Education

Bachelor's degree in Science, Engineering or related field

Tools

MS Office Suite

Job description

Quality Assurance and Regulatory Affairs Specialist

About EMED Technologies Corporation

EMED Technologies is an industry leader in the design, manufacture, and distribution of cutting-edge medical devices. For two decades, EMED Technologies has worked with clinicians, inventors, and medical companies to develop innovative medical products. Today, we are proud that both patients and clinicians can benefit from the fruits of our labor because we offer a wide variety of products and services that improve therapies and enhance clinical benefits. Also, with our dynamic team of professionals, EMED continues to work with clinicians to understand their requirements and improve upon available technologies, and we are confident that these endeavors will benefit generations to come! In addition to novel technology, EMED is proud to offer licensing agreements for patented and proprietary technologies.

About the role

• The position supports EMED's Quality Management System and ensures compliance of the quality/business systems to applicable regulations, standards, and corporate policies.
• This position reports directly to the Director of CA/QA/RA.

What you'll do

• Administration of Document Control function, including document ID issuance, revision control, coordination of review and approval, communication of implementation tasks, and maintenance of all records.
• Administration of Document Control function, including document ID issuance, revision control, coordination of review and approval, communication of implementation tasks, and maintenance of all records.
• Lead/assist with Corrective and Preventative Action (CAPA) investigations, plan development and implementation of corrective actions, author CAPA reports, and ensure completion and accuracy of all associated Quality records.
• Support nonconforming product handling and disposition assessments and manage all records.
• Coordinate the efficient handling and resolution of Customer Complaints, working with contract manufacturer sites and other EMED departments, and manage all records.
• Perform reporting and trending on Quality metrics to ensure an oversight of the compliance landscape for the site.
• Support external audits/inspections with audit readiness preparations, back-room support and response writing to non-conformances.
• May serve as an Internal/Supplier Auditor and conduct audits per schedule
• Write new and revise existing QMS standard operating procedures as directed.
• Review, approve, and maintain device history record files.
• Identify, initiate, and lead process and compliance improvement as requested.
• Interface with other EMED departments such as Engineering, Operations, Customer Service, and Regulatory Affairs as necessary to ensure success for assigned responsibilities.
• Support various Quality Assurance activities as assigned under minimal supervision/instruction.
• Assist with Regulatory Affairs tasks as assigned
• Ensure that all Quality Assurance related tasks and responsibilities defined in EMED Quality Management System Documentation are performed, as defined.

Qualifications

• Bachelor's degree with desired areas including Science, Engineering or related field.
• Minimum of 3 years of experience in Quality Assurance in pharmaceutical and/or medical device industries.
• Knowledge of MS Office Suite (Excel, Word, Outlook)
• Excellent interpersonal skills, ability to meet deadlines, manage priorities and work well under pressure.
• Ability to work in a self-directed manner and confidently deal with ambiguous issues to drive towards suitable actions.