This position will support the Quality, Regulatory, Operations, and Engineering departments by managing all open complaints, escalating Out of Box failures and suspected Adverse Events/MDR's to the appropriate teams, and providing routine and ad hoc reports in support of reliability improvement projects and other Post Market Surveillance activities.
location: Hatfield, Pennsylvania
job type: Contract
salary: $19 - 23 per hour
work hours: 9 to 5
education: High School
- Review new complaint notifications to ensure that the correct status was assigned, and coordinate with Technical Support personnel for any changes that are needed.
- Filter notifications to escalate awareness and/or additional actions for Out of Box Failures and suspected Adverse Events/MDR's.
- Manage complaints to ensure that they are closed within process timeframe.
- Obtain Device History Records as required to support investigations.
- Prepare and publish routine and ad hoc external defect reports by product family.
- Create Pareto charts and assist in data analyses for Root Cause investigations for reliability improvement projects, Verifications of Effectiveness, and similar activities.
- Maintain Daily Management boards for the Customer Defect Tracking & Resolution process.
- Continuously improve processes to further streamline and automate complaint data processing.
- High school diploma or equivalent plus 3 years of experience working in a quality assurance, medical device and/or manufacturing setting or Associate degree plus 1 year of experience working in a quality assurance, medical device and/or manufacturing setting
- Demonstrated ability to communicate effectively, both verbally and in writing
- Must have basic computer skills, including proficiency in Microsoft Office software
- ERP, SAP and QMS (Master Control) experience
- Strong interpersonal and communication skills, self-organization, and ability to work with minimum supervision
- Knowledge of GMP and Quality Systems in a regulated industry (medical device or pharmaceutical area)
- Ability to follow written documented procedures
skills: Quality Assurance, GMP (Good Manufacturing Practice), ERP System
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.