Essential Duties and Responsibilities:
- Analyze post market data to identify any potential safety signals that may alter the benefit-risk assessment of product on the market
- Update Risk Management Files if necessary
- Conduct remediation activities on existing Risk Management Files to ensure compliance to ISO 14971
- Development of PSURs in preparation for the EU MDR Transition
Qualifications, Knowledge and Skills:
- Bachelors Degree in Engineering or related field of study.
- 2+ years of experience as a Reliability or Quality Engineer in a regulated design environment.
- Prefer experience with medical device product development life cycle, including risk management and design verification & validation
- Knowledge of FDA QSR, EU MDR, ISO 13485 Design Control Procedures and ISO 14971
- Demonstrated ability to effectively work cross functionally with other departments including Product Development, Regulatory and Clinical.
- Demonstrated problem-solving and troubleshooting skills.
- Demonstrated interpersonal and communication skills.
- Demonstrated a positive, energetic approach to teamwork.
- Demonstrated ability to learn quickly and multi-task
- Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines.
We put our Ambassadors first. When it comes down to it, we know we can't fulfill our Promise to our business customers without your commitment. You represent our organization while on assignment. In return, we do our best to show our commitment to you. Our Ambassador Benefits package includes: Medical, dental and vision coverage. It also includes 401k, sick time, holiday and much more. We are an equal opportunity employer.
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.