Medical device company based in Orange County area is looking for a Post Market Surveillance Analyst II. He/she performs evaluations on various types of returned devices associated with reported complaints.
Qualifications & Requirements:
- Four-year degree, preferably in the healthcare, science, or technical fields;
- Candidate must be able to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously -
- Good problem-solving and proficient computer skills are required-
- Ability to work in a geographically diverse business environment -
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization-
- Multitasks, prioritizes and meets deadlines in timely manner-
- Strong organizational and follow-up skills, as well as attention to detail -
- Ability to maintain regular and predictable attendance
- Must have Medical Device Exp (Internships ok)
- Must be able to accomplish FMEA
- Process validation experience
- BS in STEM field
- Analysis involves using procedures, judgement and experience to determine appropriate testing of returned products; determining a well-documented and accurate root cause evaluation;
- Reviewing of Device History Records;'
- Reviewing New Product documentation
- Process validation
- Track nonconforming material and lead Material Review Board (MRB) efforts. Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing.
- Lead complaint investigations on returned product. Manage corrective action and quality improvement activities.
- Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc.
- Assist in the performance of quality system internal auditing.
- Support quarterly management review meetings.
- Establish, monitor and evaluate quality system metrics.