- Excellent Growth Opportunity with Cardiovasular Medical Device Company
- Flexibility to Work From Home
About Our Client
My client is a Medical Device manufacturer focused on coronary artery disease.
They were acquired in 2015 and have continued to scale their product portfolio. They have 65 employees, but are planning on growing out immensely due to their enhanced product portfolio.
The key responsibilities of the Quality Systems Engineer are
- Primary leader of the complaint handling process for the organization. Responsible for activities required to ensure compliance of Quality Management Systems (QMS), specifically regarding Customer Complaints. Additional responsibilities include supporting other QMS functions such as Management Review, CAPAs, NMRs, Risk Review, etc.
- Execution and coordination of activities associated with complaints process, including complaint administration and record management, investigations, reporting, as well as metrics and trending.
- Compose Monthly Complaints Meeting materials and present to Senior Leadership team.
- Coordinate with cross-functional team where necessary, understanding how to best leverage resources and functions within each business unit throughout the organization in order to succeed.
- Perform risk assessments utilizing released product risk documentation such as PFMEAs and UFMEAs. Ability to identify gaps in current documentation while providing constructive feedback necessary for modifications.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
The successful Quality Systems Engineer will
- Bachelors in Engineering, Biomedical Science, or technical degree preferred, with 2-5 years of relevant experience in a regulated industry
- Knowledge of Quality System Standards and regulations including ISO 9001, ISO 13485, and QSR
- Experience in operational quality function within a device manufacturing environment strongly preferred
- Experience participating in internal and external audits, preferably serving as qualified internal auditor
What's on Offer
My client offers competitive base salary, benefits, and work from home flexibility.