Position Title: Quality Manager

Summary: This position is for a specialist who understands the principles and practice of national and international biomedical quality including FDA and CE regulations, directives, standards and guidance.

Company Overview: Hibernicor, LLC is an innovative company responsible for designing, manufacturing, assembling, packaging, processing and labeling Asporto; a heart preservation device that allows for the improved and prolonged preservation of the donor heart. Asporto will be marketed for sale in the US and Europe.

Key Position Responsibilities:

The quality manager should define the general requirements for compliance and be able to explain how to implement and maintain a quality management system (QMS) for Hibernicor.  Specific tasks include developing quality policies, preparing a quality manual, quality control QMS documents; and maintain documenting integrity in a collaborative work environment.

The quality manager should actively participate in quality planning with company leadership and employees to ensure that the quality policy is understood throughout the organization. The quality manager will acquire and develop specific requirements for carrying out periodic review of the quality management system including how often reviews should take place; what to cover; and expected documentation.

Hibernicor is a developing medical device company and the quality manager should be able to define the resources needed including any physical space and equipment as well as environmental and human resources.  Specific tasks include developing an ISO and FDA quality requirement library, defining employee job requirements and maintaining training records.

The quality manager will work closely with Hibernicor’s stakeholders who are producing and developing company products.  These include design and manufacturing requirements and equipment installation. The quality assurance manager should translate any ISO 13485 and FDA 510k or PMA requirements to define the necessary company policies and procedures to maintain compliance. Specifically these tasks include process validation and equipment maintenance documentation.  The quality manager should have balanced understanding and experience in risk: analysis, assessment, management, and reduction.

As part of the quality manager’s responsibilities include and any remedial processes necessary in order to maintain the effectiveness of Hibernicor’s quality management system. The quality manager will develop and maintain a corrective and preventative action system for adverse events and product complaints. Specific tasks include internal audits; working with employees and external suppliers maintain quality assurance and control to identify nonconforming products and analyze quality data.

Main Duties:

Plan, coordinate, and direct the company’s quality management system.
Ensure compliance with FDA and ISO medical device standards and regulations.
Manage controls and documentation of the QMS.
Manage internal and external contract supplier quality control and audit processes.
Organize and maintain the company’s quality audit and corrective and preventative action programs.
Manage equipment calibration and maintenance schedules.

Required knowledge prerequisites:

Working knowledge of quality system regulations, ISO 13485, and FDA requirements and standards.
Working knowledge of quality improvement tools and techniques.
Proficiency with word processing and spreadsheet software.
Demonstrated ability to write technical documents.
Strong interpersonal, communication, analytical and complex problem solving skills.
Ability to develop partnerships and influence.
Ability to work independently and has strong team building skills.
Understanding of the principles of configuration management and document control.
Basic statistical analysis competence.

Individual desired employee characteristics include abilities to:

Remember Recall or recognize terms, definitions, facts, ideas, materials, patterns, sequences, methods, and principles.

Understand Read and comprehend descriptions, communications, reports, tables, diagrams, directions, and regulations.

Apply Know when and how to use ideas, procedures, methods, formulas, principles, and theories.

Analyze Break down information into its constituent parts and recognize their relationship to one another and how they are organized; identify sublevel factors or salient data from a complex scenario.

Evaluate Make judgments about the value of proposed ideas, solutions, etc., by comparing the proposal to specific criteria or standards.

Create – Put parts or elements together in such a way as to reveal a pattern or structure not clearly there before; identify which data or information from a complex set is appropriate to examine further or from which supported conclusions can be drawn.

Qualifications: BA/BS, or MS degree, fluent command of written and spoken English language, and a minimum of one year of experience in quality assurance and quality control.

Reporting: The quality manager reports to the company director.

Location: The location of the job is at the company offices either in the US or UK. If travel is necessary to accomplish the job responsibilities it is anticipated to be no more than 10% of the employment time.

Type of Employment: The position is full time.

Salary Range & Benefits: The salary and benefits are commensurate with the applicant’s qualifications and experience. For those applicants have or acquire 10 years of quality managerial experience; additional training and company support will be provided to become a certified manager of quality excellence.

Direct Inquiries and Resume to:

Dr. Andrew L. Rivard
HIBERNICOR LLC
253 Ridge Drive
Jackson, MS 39216
Email: