Director - Quality Assurance and Compliance

Employer
Q-Med Corporation
Location
Fort Lauderdale, FL
Posted
Sep 11, 2017
Executive Administration Jobs
C-Level & Executive Directors
Jobs Outside Higher Education
Other Jobs Outside Higher Education
Institution Type
Outside Academe


Job Description

DIRECTOR, QUALITY ASSURANCE AND COMPLIANCE

QUALIFICATIONS:

In-depth knowledge of quality systems, compliance practices and protocols

REQUIREMENTS:
  • Minimum of a Bachelor's Degree in Quality Assurance, Quality Control, Industrial Engineering, Chemistry, Biology or related field. Master's Degree preferred.
  • 10 years of progressively successful experience in Quality Assurance and Regulatory Affairs, preferably in positions having management responsibility
  • At least 7 years of experience in healthcare/medical device or other FDA regulated industries
  • "Hands-on" experience with Incoming Inspection processes
  • Experience with product packaging attributes such as printing, paper conversion, and paper making technologies
  • Strong working knowledge of ISO 9001 or 13485, and working knowledge of FDA 21 CFR part 820.
  • Excellent interpersonal and communication skills required
  • Strong team player with initiative and problem solving skills. Must work very closely and effectively in a team environment with the ability to work independently.
  • Strong technical writer with experience documenting Standard Operating Procedures
  • Experience interfacing directly with Customers through presentations and through complaint resolution
  • Is a "low maintenance" individual
  • Working knowledge of Microsoft office required (Word, Excel, PowerPoint)

RESPONSIBILITIES:

Including, but not limited to leading the Quality and Compliance functions for the company:
  • Leading the development and continuous improvement of QMed's entire Quality Management System (QMS)
  • Representing the QMS to executive management strategic planning meetings, and weekly management staff meetings
  • Leading the development of Customer presentation material in preparation for Customer visits and facility tours
  • Representing and symbolizing leadership for the entire QMS through daily interactions with employees at all levels of the organization
  • Reviewing and approval of inspections associated with new items, new vendors, and revisions to existing product lines
  • Coordinating all manufacturer's recalls including internal quarantine of products, RTV, and Customer notifications
  • Documenting control, reviewing, and approval of all new, revised, and obsolete documentation activities
  • Leading special project initiatives such as temperature mapping, Failure Mode Effect Analysis (FMEA), developing inspection protocols, and establishing of incoming inspection standards of acceptance
  • Interviewing and recommending optimal Inspection staff candidates
  • Developing presentation material and conducting bi-monthly inspection training/orientation sessions with associated personnel training file updates
  • Reviewing and approving 100% of all new product offerings to ensure offerings are within established product line guidelines
  • Conducting monthly internal QMS audits, and monthly audits of Pedigree records
  • Managing the CAPA databases and follow-up to closing all CAPA's
  • Leading company-wide preparation of all external 3rd party audits (Registrar and Customer)
  • Developing, maintaining, and distributing periodic QMS reports (weekly, monthly, quarterly)
  • Successfully completing all additional duties and assignments as required

Company Description
QMed Corporation is a wholesale distributor of medical, surgical, dental, and laboratory products. From our ISO certified, 104,000 square foot distribution center we supply over 9,000 individual SKU's to distributors and retailers throughout the United States and worldwide. Incorporating world class sourcing capabilities and our deep industry experience, we help our clients reduce their total cost of goods and increase their supply chain efficiency.


Fort Lauderdale, FL

c9ad3f1a8

Sun, 10 Sep 2017 13:13:16 PDT

PI99371217