Job Description
We are seeking a Quality Engineer II to join our Medical Device startup.
This role requires full-time onsite work with no hybrid or remote options.
Responsibilities:
* Ensure compliance with company policies and procedures as well as national and international regulations.
* Lead quality system compliance and improvement activities, including CAPA, audit programs, and personnel training.
* Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
* Plan, execute, report, and follow up on quality system audits. Act as an audit escort and/or support during inspections as required.
* Provide expertise in quality assurance, controls, and systems to develop and support the company's QMS.
* Develop and implement control plans, inspection plans, and testing strategies to ensure product compliance.
* Collaborate with suppliers to establish robust quality agreements and review their quality metrics periodically.
* Support internal teams in product development through first article inspection qualifications, test method development, and approval activities.
* Analyze data to support statistical rational sample testing requirements and ensure compliance with product specifications and regulations.
* Maintain detailed records of inspections, testing, and non-conformance reports.
* Collect, analyze, and report key data related to product testing, supplier performance, and internal quality metrics.
* Use data-driven insights to drive continuous improvement initiatives and ensure optimal product quality and process efficiency.
* Develop test protocols or reports to support design validations and verification activities.
* SUPPORT THE QUALITY CONTROL ACTIVITIES RELATING TO LOT RELEASE OF FINISHED DEVICES, RECEIVED PRODUCTS OR OTHER QC ACTIVITIES.
Requirements:
* Bachelor's degree in quality engineering, life science, or related field.
* 3-5 years of experience in a quality assurance role in the medical device sector, preferably in a FDA/MDR regulated environment.
* Quality certification and lead auditor certification are advantageous.
* Familiarity with FDA's 21 CFR Part 820 (Quality System Regulation) and ISO 13485:2016.
* In-depth knowledge of quality engineering principles, methodologies, and tools.
* Experience in QA activities associated with design and development of medical devices.
* Results-driven with ability to handle multiple tasks in a fast-paced environment.
* Excellent interpersonal skills and ability to work effectively with people.
* Excellent written and communication skills, fluency in English, attention to detail, and strong technical writing skills.
* Proven record of policy and procedure development.
* Good judgment/decision making and problem-solving ability.
* Highly motivated with excellent communication skills and ability to work effectively as part of a team.
* Proficiency in MS office products.
* Good business acumen and enthusiastic self-starter.