Our client, a leading Medical Device startup, is seeking an experienced Quality Engineer II to drive quality excellence in their growing team.
Key Responsibilities
* Ensure compliance with company policies and procedures, as well as national and international regulations.
* Lead compliance and improvement activities for the quality system, including CAPA and audit programs.
* Apply problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
* Plan, execute, report, and follow up on quality system audits, and support inspections as required.
* Provide expertise in quality assurance, controls, and systems to develop and maintain the company's QMS.
* Develop and implement control plans, inspection plans, and testing strategies to ensure product compliance.
* Work closely with suppliers to ensure robust quality agreements are in place.
* Support internal teams in product development through first article inspection qualifications and test method development.
* Gather and analyze data to support statistical sampling requirements and ensure compliance with product specifications and regulations.
Job Requirements
* Bachelor's degree in quality engineering, life science, or related field.
* 3-5 years of experience in quality assurance in the medical device sector, preferably in a FDA/MDR regulated environment.
* Quality certification and lead auditor certification are advantageous.
* In-depth knowledge of quality engineering principles, methodologies, and tools, such as FMEA, SPC, Root Cause Analysis, and CAPA.
* Experience in QA activities associated with medical device design and development.
* Results-driven with excellent interpersonal skills and ability to work effectively in a fast-paced environment.
* Excellent written and communication skills, fluency in English, attention to detail, and strong technical writing skills.
About Us
Pale Blue Dot Recruitment is a trusted resource for the MedTech workforce.