Centrix, Inc. is a dynamic company that manufactures and sells a complete line of dental products to the dental industry. Our range of over 300 innovative products, include temporary crown and bridge materials, applicators, delivery systems, impression materials, cements, and other products that "make dentistry easier".

POSITION SUMMARY:

Design, implement and maintain policies and procedures to ensure that quality standards are met during production.  Oversee testing of processes and products with the goal of zero defects.  Work with Production Manager to ensure all products meet established quality standards, comply with all government regulations, and are OSHA compliant.  Insure sanitation procedures are in compliance and being followed.  Provide the needed support to production, sales, and R&D to help them meet their objectives.   Always asking the question, “How is what we are doing going to ensure our products are produced defect-free every time?”

ESSENTIAL FUNCTIONS:

§  Manage, direct, control, maintain and update Centrix’s regulatory requirements for both medical devices and pharmaceuticals with a focus on results and compliance.  Liaison with appropriate regulatory control agencies.

§  Ensure compliance with all regulatory requirements and ensure that all products are produced within the established quality standards for Centrix products.

§  Create, revise and maintain Quality System to ISO 9001-2008, ISO 13485:2003, CMDR,  European Medical Device Directive, and FDA cGMP requirements.

§  Regularly audit to ensure that all procedures for testing are effective and  performed as required.

§  Manage document control, maintain tracking logs, nonconformance logs, process change logs, quality plan logs, document control logs, and design control logs.

§  Manage review process of Device History Records (DHR) to ensure product is manufactured per requirements, product accountability is correct and documentation is accurate.

§  Perform internal and external audits.

§  Investigate and trend complaints.  Conduct trend analysis of nonconformances and other quality indicators.

§  Host customer and agency audits.

§  Participate in the launching of new or improved products/processes, including validation, manufacturing procedures, SOPs, in-process and final testing, risk analysis including FMEAs and ensuring all product compliance.

§  Supervise inspection personnel.

§  Manage and conduct all QSR and cGMP training, and ensure all required trainings are up to date throughout the company.

§  Maintain a safe working environment.  Insure that all employees comply with OSHA requirements and all Centrix safety procedures.

§  Lead quarterly management review of the Quality System.

§  Work in conjunction with Human Resources to pursue continuous professional development of self and direct reports.

§  Other duties as required.

QUALIFICATIONS, SKILLS, ABILITIES REQUIRED:

§  Results oriented with the goal of achieving zero defects

§  Ability to lead organization (not just dept) in quality assurance and improvement initiatives

§  “Line” oriented person who quickly understands our products

§  In depth knowledge of Quality Systems and auditing with the ability to successfully implement, train and get results

§  ISO 9001-2008, ISO 13485:2003, CMDR,  European Medical Device Directive, and FDA cGMP requirements

§  Excellent planning, organizational, and training skills

§  Excellent interpersonal skills, with the ability to communicate well with all levels of both  management and non-management personnel

 EDUCATION, EXPERIENCE REQUIRED:

      §  Bachelor’s degree in Engineering, Biology, or Chemistry required

§  Advanced degree preferred

§  Minimum of eight years experience with Quality Systems

§  Hands on experience with FDA, both people and regulations

§  Hands on experience with ISO and European Medical Device Directive (class I and class II devices)

§  Minimum of five years supervisory experience

§  Auditing and training experience