Provide quality support for product life cycle management. Responsible for development activities of medical device products
Location: REMOTE (prefer east coast hours), can be flexible on the hours in the work schedule though (need to be day time hours) - 5 week contract only!
Responsible for assisting with the maintenance and improvement of the ISO 13485 & FDA QSR compliant Quality Management System for the facility. This position is responsible for leading and executing quality assurance programs related to manufacturing/operations, to ensure that the performance and quality of PKI products conform to established standards and agency guideline. Primary job responsibilities include supporting the operations team by ensuring that all quality-related processes are captured fully to support manufacturing/operations projects.
DUTIES AND RESPONSIBILITIES / ESSENTIAL FUNCTIONS
• Provides oversight for the maintenance of quality programs, systems, processes, and procedures to ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and regulations.
• Leads and executes site validation and equipment qualification programs; routinely involved with generation, review and/or approval of IQ, OQ, PQ protocols and reports.
• Utilizes standard statistical analysis techniques to evaluate process capability; provides technical guidance and training to other team members in statistical analysis techniques: experimental design, data analysis, sampling techniques and other traditional QA Engineering activities.
• Supports audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of audits.
• Supports the NCMR programs and ensure appropriate disposition of nonconforming parts
• Supports all departments to ensure timely root cause identification for process/product deviations; may organize, facilitate and document Material Review Board activities.
• Review device history records and release product • Other duties as assigned
Bachelor’s Degree in Engineering, Science, or technical field
5+ years of experience in quality engineering Preferred Qualifications:
• MBA Engineering
• Manufacturing/Process/Equipment Validation experience (IQOQPQ) is mandatory
• Experience with xFMEA
• Design Transfer experience
• Understanding of project management.
• Familiar with IEC 60601 and product specific industry standards
• Demonstrated ability to work effectively and positively with all levels of an organization.
• Capable of working both independently and in a team setting; team oriented and committed to continuous improvement.
• Understanding of CAPA and investigation techniques.
• Auditing exposure to 21CFR820, ISO 13485, ISO 14971, MDD, and MDSAP.
• Proficient skills with Microsoft Office (Word, Excel, PowerPoint)
• Strong organization skills