Director of Quality and Regulatory Affairs
RF Technologies - Brookfield, WI

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RF Technologies ( www.rft.com ) is a manufacturer and solutions provider of radio frequency safety, risk management, and location systems for the health care and commercial/industrial marketplaces. Established in 1987, RF Technologies is a privately held, mid-stage growth company that excels in providing RF safety and security and asset management solutions to niche markets, differentiating themselves with technology innovation, quality implementation and customer service. The company's core businesses have focused on delivering risk and safety management products to the long-term care and hospital markets, and have over 10,000 installations. That market is serviced through an extensive regional and telesales organization.

SCOPE AND RESPONSIBILITIES

Leader of the quality and regulatory functions for company, this person will ensure company systems are adequate and maintained to ensure compliance with the FDA, RFT policies, and business plans. The Director of Quality will drive process improvement throughout all departments of the company as well as investigate product and process quality problems and implement solutions.

Specific responsibilities include:
Responsible for, and has the authority necessary for, ensuring that all operations are fully compliant with the FDA's Quality Systems Regulation and company policies/procedures.

Direct the company’s safety program. Coordinate with Human Resources to provide employee safety training necessary to support company objectives and goals.

Maintain systems necessary to assure product quality and process control throughout the organization.

Investigate federal, state, and international requirements for new products or other product development projects/opportunities and communication to findings to other departments. Draft regulatory submissions as required. Coordinate with regulatory agencies to ensure timely reviews.

Review promotional materials and labeling. Recommend changes where necessary for approval.

Participate in the transfer of new products from development to manufacturing and/or distribution. Provide technical expertise.

Evaluate proposed product/process changes and report on significance of change. Provide technical assistance for validating changes to existing products or processes, where appropriate. Perform data analysis as needed.

Implement department policies and procedures as necessary to execute department's functions efficiently and effectively.

Supervise Quality and Regulatory staff and the daily administration of company quality systems. Includes: scheduling, development, performance and compensation reviews.

When necessary, conduct training of scientific and technical personnel on regulatory issues, and quality concepts, tools, and techniques.

Act as Management Representative as defined by the FDA. Host inspections and lead response to any observations.

Act as primary contact for all third party evaluations and product listings.

Specific qualifications include:
Minimum of five to eight years experience in design and manufacturing operations and quality assurance - electronics or health care industry company preferred.

Working experience with product standards, regulatory requirements, statistical controls and analysis. FDA, ISO 9001 or 13485 industry standards and regulations.

EDUCATION

Bachelor of Science degree in engineering or similar technical field.

Professional certification (e.g. ASQ CQE) desired.

RF Technologies is an Equal Opportunity Employer

RF Technologies - 2 years ago - save job
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