Join a rapidly growing and innovative medical device company that is revolutionizing patient care through advanced technology and solutions. As part of our expansion, we are committed to maintaining the highest standards of quality and compliance. We are seeking a dynamic and experienced Quality Assurance Manager to play a key role in driving our mission to deliver safe, effective, and reliable products. This is an on-site position requiring a hands-on leader to support our manufacturing, R&D, and quality teams as we scale our operations.
Position Overview:
As the Quality Assurance (QA) Manager, you will lead the QA team in implementing and maintaining robust quality systems and processes that ensure compliance with regulatory requirements (FDA, ISO 13485, etc.). You will be instrumental in supporting our company's growth by ensuring that all medical devices meet the highest standards of quality, safety, and performance. This role will involve close collaboration with cross-functional teams as we bring new products to market and scale production.
Key Responsibilities:
- Lead Quality Assurance Efforts: Manage and oversee all QA activities, ensuring that the quality management system (QMS) is fully implemented, maintained, and continuously improved to meet the needs of our growing organization.
- Regulatory Compliance: Ensure compliance with FDA (21 CFR Part 820), ISO 13485, and other applicable regulations to support the company's expansion into new markets.
- Internal and External Audits: Prepare for and lead internal audits and external regulatory inspections (FDA, Notified Bodies, suppliers). Implement corrective and preventive actions (CAPA) to address any findings and enhance our systems.
- CAPA Management: Oversee the CAPA system to ensure timely investigation and resolution of quality issues, non-conformances, and customer complaints.
- Document Control: Maintain up-to-date documentation of all quality processes, procedures, and records, ensuring compliance as the company grows and products evolve.
- Risk Management: Drive risk management processes in accordance with ISO 14971, integrating risk analysis throughout product development and production.
- Supplier Quality Management: Lead supplier qualification and audits, ensuring that as the company grows, all suppliers meet our high standards for quality and regulatory compliance.
- Team Leadership: Manage, mentor, and grow the QA team to support the increasing demands of a scaling business. Foster a culture of continuous improvement and accountability.
- Product Lifecycle Support: Collaborate with R&D, manufacturing, and regulatory teams to ensure quality is embedded throughout the product lifecycle, from design to post-market surveillance.
- Continuous Improvement Initiatives: Lead quality improvement initiatives, utilizing lean methodologies, Six Sigma, or similar tools to enhance process efficiency and product quality.
- Complaint Handling and Investigations: Oversee the complaint handling system, ensuring customer issues are resolved effectively, and use feedback to drive product improvements.
- Training: Develop and deliver training programs on quality standards and regulatory requirements to support the growth of the organization and the professional development of staff.
Qualifications and Requirements:
- Bachelor’s degree in Engineering, Quality Management, or a related field; advanced degree preferred.
- 5-7 years of experience in quality assurance within the medical device industry.
- In-depth knowledge of FDA regulations (21 CFR Part 820), ISO 13485, ISO 14971, and other global regulatory requirements.
- Proven experience leading regulatory inspections, audits, and certification processes.
- Strong background in CAPA, risk management, and implementing quality systems in a growing organization.
- Experience with product development, manufacturing, and supply chain processes, particularly in the medical device sector.
- Demonstrated leadership abilities, with a track record of managing and scaling quality teams in a fast-paced, dynamic environment.
- Strong analytical skills with attention to detail and the ability to make data-driven decisions.
- Certifications such as Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or Six Sigma (Black/Green Belt) are highly desirable.
Work Environment:
This is an on-site role, requiring the candidate to work at our facility alongside key stakeholders from operations, engineering, and quality teams. As the company grows, your leadership will be vital in ensuring hands-on support for product quality and regulatory compliance across all phases of production.
Why Join Us?
- Growth Opportunities: Be part of a fast-growing company with significant career advancement potential as we expand our product offerings and global presence.
- Competitive Compensation: We offer a competitive salary, comprehensive benefits, and opportunities for professional development.
- Innovative Work Culture: Join a forward-thinking, collaborative team dedicated to improving patient outcomes through cutting-edge medical technologies.
- Impactful Role: As the Quality Assurance Manager, you will play a pivotal role in shaping the quality and success of our expanding portfolio of medical devices.
Contract Details:
- Duration: 6 months
- Please note that we can’t provide H1B sponsorship for this role