Senior Quality Engineer - Medical Devices
Location : Saddle Brook NJ US 07663
Job Type : Temp/Contract
Reference Code : 19108-BZ-MK1
Compensation : open - 40-45/h
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Engineering
Travel : No
Relocation : No
Job Industry : Medical Devices
Job Description :
- Contract position for a Senior Quality Engineer to perform post-market supervision / management for medical device complaint handling processes, investigations, trending and product historical performance reports.
- Maintain high quality and efficiencies while also contributing to maintaining audit readiness for notified bodies.
- Supervise and mentor a team of individuals to achieve team metrics, department objectives, and provide technical expertise and guidance.
- Lead and participate in root cause complaint investigations and approvals, focusing on overall customer satisfaction to enhance the customer experience.
- Perform and approve complaint trending analysis, actively participate in Complaint Trend Review Board and lead continuous improvement processes.
- Provide reliability engineering expertise to support the new product development and risk management process by actively participating in, leading and approving product historical performance reports.
- Lead discussions with project teams, including senior leadership when necessary to improve the performance of newly developed product line(s).
- Direct and manage workflow of Reliability Engineers within the scope of assigned projects; ensure understanding, application of best practices and skill development.
- Utilize Reliability Engineering experience to solve problems and satisfy business needs.
- Work closely with other QA individuals on NC assessments, CAPA investigations, Post-Market Health Risk Assessments, and Health Hazard Evaluations.
- Perform engineering and statistical analysis to interpret test results, determine trends, probability of failure, root cause and corrective action.
Required Qualifications :
- BS Engineering.
- Minimum 5 years of experience as a Reliability or Post Market Surveillance Engineer, leading failure investigations and/or performing failure analysis to identify root cause and corrective action.
- Prefer 5 years experience in a design and manufacturing environment.
- Ability to achieve work objectives both independently and as a leader/member of a work team.
- Must be results-oriented, able to multi-task, a quick learner and able to respond to the urgent needs of the team and be able to meet deadlines.
- Applied knowledge of regulatory requirements: ISO 9001 or ISO 13485, Quality System Regulation 21 CFR 7, 803, 806 and Medical Device Directive.
Contact: Monique Kleiman