Are you a problem solver who can handle the complexity of ISO 13485 and FDA Quality System Regulations? Incisive Surgical is looking for a roll-up-the-sleeves engineer to join our 30-person company that can deliver real post-market surveillance insights for projects within our regulated and highly documented industry.
This position will drive post-market surveillance investigations which are fully integrated into our team’s feedback metrics. We are a small company with tight interdepartmental cooperation that hires smart teammates who are fully accountable to these metrics. This is NOT a tiny cog in a lumbering multinational type of position, so be ready to contribute to real corrective and preventive actions by developing scientific hypotheses and finding relationships through protocol-driven studies. This position reports to the Director of Quality.
This position is responsible for:
- Coordination, investigation, and communication of complaints, returns, and other post-market surveillance data for the INSORB Skin Stapler which is FDA-cleared and CE Marked (over 1,000,000 sold since wound closure with absorbable staples was commercialized in 2005);
- Creative work to develop and implement a scheme for data entry and analysis out in the supply chain that will link risk mitigations and post-market signals;
- Achieving operational excellence including measurement systems analysis, defect reduction, receiving inspection, lot characterization, and scrap analysis trending;
- This engineer may also participate in Design Assurance Testing, Test Method Development, Internal Quality Audits, Manufacturing Quality support, and Quality System improvements.
DUTIES AND RESPONSIBILITIES:
- Investigate returned product from customer complaints and perform root cause analysis; document investigations and maintain a fully compliant complaint system. Investigations require safely handling Returned Goods biohazards with the potential for exposure to blood borne pathogens; blood borne pathogens training will be required;
- Lead special assignments on problem solving and trouble shooting of quality related issues;
- Use Assurx CATSWeb system to publish quality metrics for the company and for suppliers using web portals;
- Perform analysis of statistical process control (SPC) charts;
- Coordinate and document periodic sterilization dose audits of Gamma sterilization;
- Support Engineering and Operations groups with on-going development and manufacturing testing. Work is performed mostly in office and lab environment, up to 30% off site travel may be required, primarily to supplier manufacturing sites;
- Assist with testing, tracking, and monitoring of progress on CAPA projects and Internal Audit action items.
- A four-year engineering degree from an accredited institution and a minimum of 2 years of medical device manufacturing experience is an absolute must (we need people who know the record-keeping expectations of lab work in this industry... you need to accept them and work hard on them...we don’t want to waste our time with people who will whine about them);
- Focused attention to detail to solve problems within the quality system (we have no time for creative problems solvers who cannot thoroughly document their work… this just creates more work for other people on the team and we are too busy to do your tasks for you);
- Strong sense of integrity (we are making a medical device after all),
- Expertise in the use of computer for documentation and statistical analysis, including writing code (we use SAS JMP for stats – this is a discovery tool for analysis and visualization which can be scripted for repetitive tasks).
Our mission is to enhance patient care by providing high quality, innovative mechanical surgical solutions for skin...