Quality Assurance, Specialist, Med Device
We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our dedicated team in ensuring the quality and regulatory compliance of our Med Device Products! The QA Specialist will play a crucial role in maintaining and enhancing the overall quality management and product development processes. The perfect candidate would be willing to work hands-on to ensure compliance and support a quality-oriented culture throughout the site. If you see yourself being a leader of innovation and discovery this opportunity is for you.
The QA Specialist will be responsible for…
- Collaborate with cross-functional teams to establish and maintain effective quality assurance processes in alignment with regulatory requirements and company standards.
- Participate in the development, implementation, and continuous improvement of the Quality Management System (QMS) to ensure compliance with ISO 13485, FDA regulations, and other relevant standards.
- Review and approve design control documents, including design specifications, risk assessments, and verification/validation protocols, to ensure the products meet quality and safety requirements.
- Conduct thorough audits of manufacturing processes, supplier activities, and internal systems to identify areas for improvement and ensure adherence to quality standards.
- Assist in the creation and execution of validation protocols for equipment, software, and processes to support product development and manufacturing.
- Perform root cause analysis and corrective/preventive actions (CAPA) for quality incidents, deviations, and non-conformities to drive continuous improvement and prevent recurrence.
- Support the preparation and submission of regulatory documentation, such as 510(k) submissions, Technical Files, and Design Dossiers.
- Collaborate with the Regulatory Affairs team to ensure that quality and compliance aspects are integrated into regulatory strategies and submissions.
- Provide guidance and training to employees on quality-related matters, ensuring a culture of quality consciousness and regulatory compliance.
- Stay current with industry trends, regulations, and best practices related to medical device quality assurance and share relevant information with the team.
The QA Specialist should have the following qualifications….
- Bachelor's degree in a relevant scientific or engineering field; advanced degree is a plus.
- Minimum of 3 to 5 years of experience in quality assurance within the medical device industry.
- Strong knowledge of ISO 13485, FDA regulations (21 CFR Part 820), and other relevant quality standards.
- Experience with design control processes, risk management methodologies, and validation protocols.
- Excellent communication and collaboration skills, with the ability to work effectively across cross-functional teams.
- Detail-oriented mindset with strong analytical skills and the ability to think critically.
- Certifications such as Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) is a plus!
- Experience with medical textiles or compression fabrics are a plus!
- Ability to work remotely.
- Competitive compensation package.
- Comprehensive benefits & PTO.
If you are interested in the role of QA Specialist, don't hesitate to apply today!