Quality Engineer

Job Description

Major Accountabilities:
Technical ownership to perform formal and/or informal root cause investigation and corrective action of product, equipment, material, or process non-conformances, anomalies, observations, etc.
Identifies and implements initiatives that improve customer facing quality, reliability, or cost reduction.
Investigates and documents customer complaints per established procedures and timelines
May perform hands-on troubleshooting of customer returned devices and complete associated sample investigation logs
Ensures compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies pertaining to medical devices
Process ownership to ensure manufacturing processes remain in a validated state and yields products that adhere to all specifications, requirements, and controls
Identifies and implements initiatives that improve manufacturing yield, cycle time, supplier performance, flow, operator safety & ergonomics, process simplicity, clarity, repeatability, and robustness

Familiarity with regulatory reporting requirements for medical devices (e.g. MDRs, Vigilance reports, etc);
Familiarity with medical device complaint files and quality records;
Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard
Strong computer skills (including Word and Excel)
Demonstrated written and verbal communication skills
Ability to assimilate technical details and apply them to investigation conclusions