Quality Specialist

Need a Challenging and Rewarding Career?

Automation Personnel Services is looking for a professional Quality Specialist who will oversee all quality functions for our Corporate Office and Distribution Centers in Largo. This position is responsible for various Regulatory Affairs (RA) and Quality Assurance (QA) activities for Class I-II Medical Devices. We are seeking a hard-working, detail-oriented professional with experience in all aspects of Quality Management in a medical device setting. In addition to exceptional leadership and analytical skills, this position requires a roll-up your sleeves attitude. The Quality Manager will have a broad scope of responsibilities and is required to wear many hats in this dynamic, growth-oriented, small corporate setting. This position will interact with all levels of employees in the company and reports to the Director of Global Sourcing & Quality.

KEY RESPONSIBILITIES:
Inbound inspection: establish area, product inspection, product disposition, holding and releasing of product.
Support quality processes as required: non-conformance (CAPA), quality training (SOPs and quality guidelines), management review, document control, change management, and records management.
Update Quality Systems Manual, policies and procedures as required.
Monitors changes to local regulations in order to implement new Company procedures or update existing procedures to facilitate compliance.
Maintain all documentation in accordance with Good Manufacturing Practices requirements stipulated in the Food and Drugs Act and Regulations.
Review promotional materials (i.E. Brochures, catalogues, websites, etc.) and evaluate regulatory compliance.
Demonstrate knowledge of Quality Management Systems for Medical Devices:
? American National Standard ANSI/ISO/ASQ Q9001-2008, Quality Management Systems Requirements
? International Standards Organization ISO 13485-2016: Medical Devices Quality System Regulation.
? Title 21 of the United States Code of Federal Regulations(CFR) Part 820 Quality System Regulations as amended;
? Title 21 of the United States Code of Federal Regulations (CFR) Part 803 Medical Device Reporting as amended;
Perform inter-company and external manufacturer audits to ensure compliance.
Act as a liaison with Health FDA for recalls or during regulatory inspections.
Evaluate medical device classification for new products, and compile medical device submission to Food and Drugs Act (FDA) for Class I-II medical device applications.
Review proposed changes to medical devices and assess possible regulatory impacts.
Manage complaint handling, mandatory problem reporting, and recall processes as required.
Demonstrate knowledge of regulatory requirements and utilizes depth and breadth of experience to assess regulatory changes, risk and business impact.
Adheres to established policies and procedures.
Demonstrates detail-oriented attention in all facets of responsibilities.
Instill and drive a regulatory culture.

REQUIRED EXPERIENCE & QUALIFICATIONS:
Minimum Bachelor s degree in a relevant Science and/or Engineering discipline.
Minimum 3-5+ years experience in a Quality Role within the medical device industry (distribution or manufacturing) with a focus on quality systems, regulations and complaints management.
Applied comprehensive knowledge of Quality Systems Regulations and Medical Devices.
Applied comprehensive understanding of FDA/ QSR/ CFR/ISO 13485 guidelines. Experience with Regulation (EU) 2017/745 preferred.
Certification in regulatory affairs program preferred
Intermediate Auditing Skills.
Intermediate level skill in Microsoft Excel and Word
Highly organized, problem solving, analytical and focused; good attention to detail. IND123LI

APSTampa
Equal Opportunity Employer