Creates and maintains Technical documentation for product development.
Summary of Essential Job Duties:
Primary responsibility will be to work with Product Development/Management, associates, contractors, and outsourcing firms as applicable to develop product requirements and Technical file Documentation.
Collaborates with engineering and manufacturing functions to ensure technical documents are in place.
Collaborates with Engineering and Manufacturing to develop and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Must work with all aspects of regulatory affairs (FDA, OSHA, MDR, TGA, ROHS, REACH, PPE others as applicable) and help the organization make appropriate decisions regarding regulatory affairs
Works to ensure process and procedures are controlled, accurate in reflecting the current process and meet expectations as defined ISO policies.
Will utilize corrective/preventive actions, continual improvement, customer complaints and nonconformances and investigating root cause and effectiveness of actions taken and Post market Surveillance.
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
Sound knowledge of process validation, process verification, process monitoring, Gage R&R activities, with ability to document and execute validation / qualification work.
Skills/Qualifications:
Excellent organizational and follow-up skills
Detailed oriented individual with high energy level
Strong problem solving and analytical skill sets
Ability to conceptualize interactions of process with regards to integrating for a effective and efficient quality management system as it relates to the organizations goals
Self-motivated with a strong sense of urgency
Excellent communication skills oral and written
Ability to multi-task, organize and prioritize ongoing projects
Ability to treat confidential information with sensitivity
Must be assertive, objective, and participate and able to work with all levels of Associates
Must be flexible with work schedule
Must be able to travel
Strong leadership skills with the ability to drive the continual improvement process within the organization
Strong commitment to quality
Microsoft Suite – advanced skills in Excel
Ability to work in a fast pace environment
Master Control experience a Plus
Education, Certificates, Licenses, Registrations:
BS/BA in Engineering or related function, Quality Control Engineer
5 or more years’ experience QMS/ISO/Regulatory experience
