Quality Assurance & Regulatory Affairs Manager

Quality Assurance/Regulatory Affairs Manager

Reports to the President, and collaborates closely with Engineering, Manufacturing, Sales, and Administration.

Responsibilities include:

 

? Performing internal audits.

? Addressing non-conformities from previous internal and external audits.

? Conducting a Management Review of the Quality System.

? Following-up on and closing pending Preventive and Corrective Action Requests.

? Insuring that organizational systems and training is in place.

? Preparing organization for ISO 9001 and 13485 audit.

? Ensuring that documentation and design controls are appropriate for organization.

? Administering document control and configuration management system.

? Overseeing established calibration and testing program.

? Assisting the management team and provide QA support as necessary.

? Maintaining Design History File.

Must Have:

? At least a Bachelor?s Degree in Engineering, a related technical field, or equivalent.

? At least 5 years of work experience in Quality Assurance, should be combined with a demonstrated track-record of accomplishments as a Quality Assurance Manager, and with satisfying customers in technology-driven, developing companies.

? Experience with FDA and international Quality System rules, regulations, including planning and implementation is very important.

? Oral and written communication skills, strong interpersonal skills, and superior organizational abilities.

? Ability to take initiative, to maintain confidentiality, to meet deadlines, and to work in a team environment essential.

? PC-based computing experience (word processing-Word, spreadsheet-Excel, presentation- PowerPoint, documentation s/w) essential.