Vice President of Quality and Regulatory Affairs Optovue
THIS JOB HAS EXPIRED
This position reports to the CEO. As a senior leadership team member, you will be responsible for providing company direction in the areas of Quality Assurance and Regulatory Affairs. Further, you will manage company activities in order to maintain compliance with the FDA, MDD, ISO, Notified Bodies and state, federal and international regulations.
Senior level RA/QA management in a regulated medical device environment.
A thorough understanding of software-based diagnostic medical equipment is essential.
Extensive cross functional experience with regulatory issues pertaining to FDA, MDD, ISO 13485, QSR and 510(k) filings.
High level of regulatory experience with an expert level of understanding in FDA legal requirements
Demonstrated success in developing an RA/QA staff including document control function and championing a QA mindset across all departments.
Hands on experience with complaint management resolution and a comprehensive understanding of CAPA.
Experience in electronic document control processes and PLM software.
Thorough understanding of the medical device development manufacturing process.
Experience in the development, implementation and documentation of staff QA training curriculum.
Demonstrated understanding of the Internal Quality Management System.
Previous responsibility over Document Control, Internal and External Audits, Calibration program, Training and other quality systems areas.
Hands-on experience in medical device application processes from inception to completion.
Demonstrated ability to successfully interface and provide guidance to multi-disciplined teams from project inception through project completion with respect to FDA requirements, agency and vendor audits, corrective actions, and complaint management.
Experience in validation of new products and familiarity with new product innovation processes.
Background Preferred (but not required):
Master of Science or other advanced degree in a related field
ASQ Professional Certification
Other Essential Abilities and Skills:
Excellent written and oral communication skills
Exceptional interpersonal and relationship building skills
Ability to build a high performing team.
Excellent organizational skills with superb attention to detail.
Ability to manage multiple priorities with the ability to develop and manage a budget
||41752 Christy Street |
Fremont, CA 94538
THIS JOB HAS EXPIRED