$200K - $250K(Ladders Estimates)
The Director, Quality Assurance is responsible for leading a multi-site team associated with development, implementation, surveillance, and improvement of the Quality Management System in accordance with all applicable regulatory requirements. This includes sustaining of internal processes key to optimal performance of the Quality Management System across BioTelemetry Technology sites.
Essential Duties/Responsibilities (list 6-8 primary duties/responsibilities required for an individual to regularly perform in this role):
•Development, implementation, surveillance, and improvement of the QMS in accordance with all applicable regulatory entities and requirements.
•Responsible for leading efforts to complete consolidation of existing BioTelemetry Technology quality management systems and associated documentation into the Arena PLM.
•Define and uniformly implement across BioTelemetry Technology sites the internal processes governing all aspects of regulated R&D, RA/QA, and manufacturing efforts to take us to a level of "state of the art" pertinent to all regulatory expectations.
•Plan and act in accordance with FDA QSR, ISO13485:2016, EUMDR, and all other regulations binding in locations where product will be sold.
•Interact with all governmental and regulatory inspections as appropriate.
•Work effectively and cooperatively with other functions in all matters of the organization.
Education and Experience Requirements (minimum education level and years of relevant experience required):
•Education: Bachelor's degree in Engineering or related scientific / technical field
•Relevant Work Experience:
oMinimum of 10 years' experience in medical device QA/RA systems environment, at least five of them in a leadership role.
oPrevious experience in development and implementation of QA/RA systems in compliance with FDA Quality System Regulation, ISO 13485:2016, EUMDR, and other applicable international regulations.
oExperience with firmware, software, and electromechanical medical devices highly desired.
oExperience with FMEA, creating and maintaining risk management files compliant to ISO/EN 14971.
oExperience with Usability Engineering in accordance with current version of IEC 62366.
oExperience in writing SOPs and other QMS documentation.
oExperience as lead auditor to ISO 13485:2016; familiar with MDSAP auditing.
•Licenses/Certifications: Lead auditor ISO 13485:2016
Required Knowledge, Skills, and Abilities (basic knowledge/skills/abilities training, technical, operational, behavioral/interpersonal, management, communications, etc. required for an individual to regularly perform in this role):
•Knowledge/Abilities –Technical Skills: Leadership skills required; ability to prioritize tasks for self and team; level of understanding to pace work completion to the needs of the company. Strong background in CAPA, non-conformances, audits, and change control. Strong knowledge and understanding of US Quality System Regulations 21 CFR Part 820, ISO 14971 and ISO 13485 regulations. Experience / knowledge of medical device complaint handling. Knowledge of data analysis and statistical techniques preferred.
•Communication Skills (Verbal/Written): Strong verbal, written, and interpersonal communication skills.
•Management/Leadership Skills: Ability to work with minimum supervision. Ability to draw out the best in others as a means of supporting optimal work group / business performance.
•Customer Service: Ability to achieve deliverables within a project per the timeline.
Valid Through: 2019-9-24