We are seeking a highly experienced Senior Quality Assurance Specialist to join our team in the development of medical devices. The ideal candidate will have a proven track record in ensuring product quality through effective quality management systems.
Key Responsibilities:
* Lead compliance and improvement activities associated with the quality system, 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, acting as an audit escort or supporting coordination during inspections.
* 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.
* Gather and analyze data to support statistical rational sample testing requirements during early product development and ensure compliance with product specifications, regulations, and internal requirements.
* Prepare and 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.
* Support the quality control activities, relating to lot release of finished devices, received products, or other QC activities.
Requirements:
* A degree in quality engineering, life science, or a related field.
* 3-5 years of experience at a quality assurance role in the medical device sector, preferably in a FDA/MDR regulated environment.
* Quality certification and lead auditor certification are an advantage.
* In-depth knowledge of quality engineering principles, methodologies, and tools (FMEA, SPC, Root Cause Analysis, CAPA, investigations).
* Excellent interpersonal skills, ability to work with people to achieve results, and excellent written and communication skills.
* Proven record of policy and procedure development, good judgment/decision-making, and problem-solving ability.
* Highly motivated with excellent communication skills and proven ability to work effectively as part of a team and interact professionally with all organizational levels.
About the Role:
This is an exciting opportunity for a seasoned quality professional to make a meaningful contribution to the development of innovative medical devices. As a Senior Quality Assurance Specialist, you will play a critical role in ensuring the highest standards of quality and regulatory compliance throughout the product lifecycle.
What We Offer:
We offer a dynamic and supportive work environment that fosters collaboration, innovation, and growth. Our team is passionate about developing medical devices that make a real difference in people's lives. If you share our passion for quality and excellence, we encourage you to apply for this challenging and rewarding role.