As an innovative and growing company, Epsilon Imaging strives to deliver cardiovascular visualization, analysis and management solutions that exceed customer expectations for an improved patient continuum of care. We are seeking team members willing to work in a fast paced environment with challenging opportunities focused on customer satisfaction, please send a resume along with a cover letter to careers@epsilon-imaging.com

Current career opportunities include:

Quality & Regulatory Manager

FSLA STATUS: Exempt

BASIC FUNCTION: Quality System Operations & Regulatory Affairs

REPORTING TO: CEO

REQUIRED TRAVEL: <10%

Additional Information

PRIMARY DUTIES:

Quality System Operations:

  • Perform all periodic tasks and analyses required by Epsilon’s QMS of the Quality Mgr
  • Perform/manage the Document Control process
  • Identify Personnel Training needs, initiate/provide training, document training
  • Perform/manage the Complaint Handling process
  • Identify/initiate CAPAs, monitor open CAPA plans and drive to resolution
  • Maintain Device History Records; ensure DHRs are properly initialized
  • Coordinate Management Review process; lead and present the reviews
  • Perform/manage Quality Data Analyses
  • Initiate and respond as needed to Internal Audit processes
  • Develop Quality Plans and provide periodic status against plans
  • Perform/manage Purchasing Controls process
  • Oversee and participate in Design Control and change management processes
  • Ensure all Epsilon QMS processes are being complied with by all personnel
  • Maintain and enhance Epsilon QMS processes and documentation

Regulatory Affairs:

  • Monitor Complaint Handling process for issues requiring regulatory action
  • Review engineering change requests and identify applicable regulatory requirements
  • Ensure Technical File is maintained current
  • Participate in risk analyses and Risk Management process
  • Review and ensure QMS process changes and additions conform to regulatory needs
  • Monitor for applicable regulatory changes; obtain and review new/revised directives/standards/guidance; adjust Epsilon systems as required
  • Submit all required periodic and any other required reports to regulatory entities
  • Investigate regulatory regimes of other countries as needed
  • Plan and prepare/assemble and track regulatory submittals when and where needed
  • Evaluate, engage, and oversee regulatory consultants/contractors for Epsilon
  • Maintain Epsilon regulatory registrations
  • Point-of-contact for regulatory visits by the FDA inspectors and Notified Body auditors

MINIMUM QUALIFICATIONS

  • 5+ years of experience in the medical device industry primarily in a quality and/or regulatory role
  • Working knowledge of current FDA QSR, ISO 13485, MDD 93/42/EEC, CMDR
  • Ability to assess current company practices against external standards, guidance, regulations, and industry ‘best practices’ and judge applicability to Epsilon products
  • Ability to make decisions related to product quality, acceptance criteria, marketing materials, and release of company products that will withstand regulatory scrutiny
  • Ability to identify and implement improvements to quality system processes
  • Ability to find optimal process solutions that satisfy regulatory requirements and maintain and enhance Epsilon’s operational agility as well as its product and service quality
  • Effective written and oral communication skills
  • Effective reasoning and problem solving ability
  • High level of attention to detail
  • Organizational and motivational skills to exert the necessary influence over highly entrepreneurial and innovative engineering, fulfillment and support operations
  • BS in Engineering or Life Sciences

HIGHLY DESIRABLE

  • 10+ years of experience in the medical device industry primarily in a lead quality and/or regulatory role
  • Coursework/training in quality system management and applicable experience in organizing, administering and auditing quality management systems
  • Coursework/training in regulatory affairs and applicable experience in engagements with regulatory authorities and regulatory affairs services providers
  • Track record of responsibility for successful FDA and/or Notified Body inspections/audits
  • Master’s degree in Quality or Business-related field of study

Controller

Scope of the Position: This is a hand-on position responsible for the finance and administrative activities of the organization. The Controller optimizes company operations and manages the effective use of resources with the majority of effort focused on accounting and finance.

Includes, but not limited to, monthly closing of the books, account reconciliations & analysis schedules. This position applies the generally accepted principles of accounting, analyzes financial information, prepares management reports, and requires a willingness to be involved with all levels of accounting, from preparing and posting entries to analyzing information. The position requires a high performance individual that will excel in a small, fast paced group.

Additional Information

PRIMARY DUTIES:

  • Maintain all accounting records for company, including general ledger and all subsidiary ledgers
  • Prepare journal entries and reconcile general ledger and subsidiary accounts
  • Prepare and distribute specialized departmental financial reports
  • Prepare other special reports on an as needed basis by collecting, analyzing, and summarizing information and trends
  • Prepare and file monthly, quarterly and annual financial statements for the Company
  • Protect assets by establishing, monitoring, and enforcing internal controls
  • Review and track receivables; reconcile monthly accounts receivable; review payables and track payments
  • Process credit applications and manage collections to keep receivables timely
  • Participate in annual budgeting process and provide timely reporting of progress against budget.
  • When appropriate, year-end audit preparation and coordination, including preparation of audit schedules for external auditors and acting as a liaison between the company and auditors
  • Fixed asset accounting and tracking
  • Comply with federal, state, and local legal requirements by studying existing and new legislation; anticipating future legislation; enforcing adherence to requirements; filing financial reports; advising management on needed actions
  • Maintain all required financial and tax reports for county, state, and federal regulatory organizations
  • Maintain confidentiality of all sensitive information.
  • Maintain a high level of customer service and friendly atmosphere
  • Proactively participate in cross-functional and company-wide initiatives
  • Use various software applications, such as spreadsheets, relational databases, statistical packages, and graphics packages to assemble, manipulate and/or format data and reports
  • Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies
  • Possess the interpersonal skills to deal effectively with staff at all levels of the organization
  • Communicate clearly and persuasively in both positive and negative situations; develop written documents which clearly express ideas, processes, procedures, concerns, and expectations
  • Display willingness to make timely decisions, exhibiting sound and accurate judgment; routinely acts with integrity and high ethical standards.
  • Others duties as assigned

SECONDARY DUTIES:

  • Perform general office administration duties, including purchasing, facilities and IT management.
  • Provide contract management, including the negotiation, implementation and close-out activities for consultants, subcontractors, and federal and state initiatives.
  • Establish and oversee policies and procedures for ensuring government and regulatory compliance for the corporation as a whole, and on a variety of specific projects.

MINIMUM QUALIFICATIONS

  • Bachelors Degree in Accounting or business-related field
  • Seven to ten years of senior-level accounting experience, including cost accounting and financial analysis
  • Experience with Peachtree accounting software
  • Proficiency in Microsoft Office Software suite, including Excel, Word, and PowerPoint
  • Must possess excellent verbal and written communication skills
  • Strong problem-solving and multi-tasking skills
  • Self-motivated and capable self-starter
  • Ability to work in a fast paced, at times stressful, environment.

HIGHLY DESIRABLE

  • Experience in medical device or healthcare businesses
  • Experience with ISO 13485 compliance
  • MBA or MAC desirable
  • CPA license
  • Advanced experience in Excel
  • Progressive increase in responsibilities in the areas of leadership and management