Job Announcement: Quality Assurance Professional - Medical Device
Quality Assurance Professional
General Job Description:
Provide QA support for a Medical Device Laser company. We have immediate need for 1 to 2 QA professionals who have some combination of the background listed below. Job Title and compensation will be commensurate with experience. We are a small company, and as such, need people who can cover multiple areas of QA responsibility with ability to not only set up QA systems, but also perform day to day operations
Manage and maintain customer complaint process, including data analysis for trending. Ensure all sources of complaint data are evaluated for input to the system.
Perform Adverse Event Reporting both Domestically and Internationally
Manage and maintain Corrective Action (CAPA) process, including data analysis for trending.
Assist the QA/RA Director as needed in Leading and Managing audits by external regulatory authorities
Act as Quality Assurance liaison to local Engineering, Purchasing, Marketing, and Manufacturing.
Assist in the maintenance of product Technical Files and Design History Files
Lead and Manage Internal audit program
Manage customer returns process.
Manage employee Quality System and GMP training
Participate on product design teams as QA team member
Perform Annual Post Market Trending
Host MRB meetings to ensure timely disposition of NCMRs
Perform periodic random Quality Audits
Perform supplier qualification / Requalification and Maintain ASL
Perform quarterly supplier monitoring,
Prepare and disposition non-conforming material reports
Manage Suppliers and Supplier Corrective Actions
Maintain Calibration System and Ensure appropriate actions are taken for out of calibration equipment
Perform Device History Record (DHR) Reviews and Approvals
Create and Revise SOP’s – WI’s in support of QMS and initiate ECO’s
Create and revise Inspection test plans
Perform First Article Inspections
Perform incoming inspection
Initiate process improvement in Quality Systems for long term productivity gains
Minimum of 2 years working as a QA professional in a Medical Device company. BS degree (Engineering preferred). Good understand of 21 CFR part 820 and ISO 13485 requirements, GMP and GDP. ASQ certification(s) a plus
Application Information & Contact (How to Apply)
To apply, contact Mark Perkins via email at firstname.lastname@example.org