HERE'S WHY YOU'LL LOVE THIS JOB:
You thrive in a fast pace work environment (it's not boring).
You love to focus on all the little details that make the big picture happen.
You enjoy juggling competing priorities in a fast-paced environment.
You thrive in a team-focused environment.
You love contributing to innovation, which can be chaotic and rewarding all at once!
HERE'S WHAT YOU'LL BE DOING:
Responsible for overseeing all risk management activities throughout the product realization process.
Perform and/or direct completion of specific product verification/validation testing and analyses required to satisfy both regulatory and internal requirements, including the preparation of quality plans and technical reports.
Provide support for problem solving investigations to guide root cause analysis/corrective action throughout the product realization process.
Leads failure investigations for product complaints.
Provide support for Supplier Management, including qualifying, auditing and performing ongoing assessments.
HERE'S WHAT YOU'LL BRING TO THE ROLE:
Bachelor's Degree in Engineering or Scientific field with a minimum of five (5) years related experience.
Strong working knowledge of ISO 14971:2019 Medical devices -- Application of risk management to medical devices.
Strong working knowledge of ISO 13485:2016 and FDA 21 CFR 820 requirements for design development, usability engineering, supplier management and failure analysis.
Ability to manage competing priorities in a fast-paced environment.
Must be able to work in a team environment, including inter-departmental teams and key stakeholders representing the organization on projects.
We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.