We are seeking an experienced Quality Engineer to join our team. The successful candidate will be responsible for ensuring product quality during early development phases through to commercial.
About the Role:
This position requires a proven track record in Quality and Regulatory control of medical devices. You will focus on leading compliance and improvement activities associated with the quality system, applying thorough problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
Responsibilities:
* Comply with policies, procedures, and applicable national and international regulations.
* Lead compliance and improvement activities associated with the quality system.
* 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 or support during inspections as required.
* Provide expertise in quality assurance, controls, and systems to support and develop the QMS.
* Develop and implement control plans, inspection plans, and testing strategies to ensure product compliance with design and regulatory requirements.
* Work closely with suppliers to ensure robust quality agreements are in place, including periodic review of their quality metrics.
* Support internal teams in the development of products through first article inspection qualifications, test method development and approval activities, and commercialization.
* Analyze data to support statistical rational sample testing requirements during early product development and ensure compliance with product specifications, regulations, and internal requirements.
* 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, ensuring optimal product quality and process efficiency.
* Develop test protocols or reports to support design validations and verification activities.
* Support quality control activities related to lot release of finished devices, received products, or other QC activities.
* Review and approve changes to product processes for existing medical device products conducted in compliance with global regulations and internal procedures.
Requirements:
* A degree in quality engineering, life science, or a related field is required.
* 3-5 years of experience in a quality assurance role in the medical device sector is essential, preferably in an 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 is required.
* In-depth knowledge of quality engineering principles, methodologies, and tools is necessary.
* Experience in QA activities associated with the design and development of medical devices is required.
* Results-oriented with excellent interpersonal skills, ability to work with people to achieve results, and strong technical writing skills are essential.
* Proven record of policy and procedure development is beneficial.
* Good judgment, decision-making, and problem-solving ability are required.
* Excellent communication skills, proficiency in MS office products, and good business acumen are desired.
* A highly motivated individual with excellent communication skills and the ability to work effectively as part of a team is preferred.