Job Title: Quality Assurance Specialist
As a Quality Assurance Specialist, you will play a key role in ensuring the delivery of high-quality products to our customers. Your primary function will be to provide support to cross-functional teams including Production, Quality Control, Purchasing, Facilities, IT, Regulatory, Analytical Lab, Research and Development, and Engineering Sustaining teams.
Key Responsibilities:
* Provide Quality Assurance support to process validation, change requests, non-conforming product issues, corrective and preventive action program, design and process FMEA, risk assessment, and associated quality system documentation.
* Support the development and implementation of quality systems, processes, and procedures to ensure compliance with regulatory requirements.
* Collaborate with cross-functional teams to identify and implement opportunities for improvement.
* Develop and maintain quality metrics and reporting tools to track performance and drive continuous improvement.
* Conduct audits, assessments, and investigations to identify and address quality-related issues.
Required Skills and Qualifications:
* Bachelor's degree in a relevant field such as science, engineering, or quality assurance.
* Minimum 4 years of experience in a quality assurance or related role, preferably in the medical device industry.
* Proven knowledge and experience with ISO13485, ISO14971, EU Medical Device Regulation 2017/745, and FDA QSR including 21 CFR Part 820 and 21 CFR Part 11.
* Excellent communication and interpersonal skills with the ability to work effectively at all organizational levels.
* Strong analytical and problem-solving skills with the ability to identify and resolve complex quality-related issues.
Benefits:
* Competitive salary and benefits package.
* Opportunities for professional growth and development.
* Collaborative and dynamic work environment.