Staff Quality Assurance Specialist

About Mendaera, Inc.

Mendaera is developing technology that will enable all healthcare providers to do more for their patients. Our platform combines real-time imaging, robotics, and artificial intelligence to make precise and consistent intervention more accessible. Our aim is to eliminate barriers in the patient journey, accelerate recovery, delight customers, and reduce cost of care.

About the Opportunity

We are seeking an experienced Staff Quality Assurance Specialist to lead and enhance our quality management systems within a regulated medical device environment. This senior-level position requires deep expertise in international quality standards, regulatory compliance, and supplier quality management. The successful candidate will serve as a subject matter expert, driving continuous improvement initiatives while ensuring adherence to stringent quality requirements. The annual salary range for this role is $140,000 to $170,000.

About You

We are looking for candidates who: thrive in fast-paced environments; embrace ambiguity; can create frameworks and work-products from scratch; are able to level between micro and macro analysis; possess critical and system thinking ability; are detail oriented.

Key Responsibilities

Quality System Leadership

• Lead the development, implementation, and maintenance of comprehensive quality management systems in accordance with ISO 13485 and 21 CFR Part 820 requirements
• Drive quality system improvements and modernization initiatives to enhance operational efficiency and regulatory compliance
• Serve as the primary quality liaison with regulatory bodies during inspections and audits
• Develop and maintain quality policies, procedures, and work instructions that align with current regulatory standards

Auditing and Compliance

• Plan, conduct, and oversee internal quality audits across all functional areas to ensure systematic compliance with established quality standards
• Lead external supplier audits and certification processes, evaluating supplier quality systems and capabilities
• Coordinate and support regulatory audits and inspections, serving as the technical expert during interactions with FDA, Notified Bodies, and other regulatory authorities
• Investigate quality system nonconformances and implement effective corrective and preventive actions (CAPA)

Supplier Quality Management

• Establish and maintain robust supplier qualification and monitoring programs, ensuring suppliers meet quality, regulatory, and performance requirements
• Develop supplier quality agreements and performance metrics, conducting regular supplier performance reviews
• Lead supplier corrective action processes and manage supplier quality issues through resolution
• Collaborate with procurement and engineering teams to evaluate new suppliers and maintain approved vendor lists

Risk Management and Process Improvement

• Implement and maintain risk management processes in accordance with ISO 14971 and other applicable standards
• Lead cross-functional teams in quality improvement initiatives, utilizing statistical tools and methodologies
• Conduct management reviews and present quality metrics, trends, and improvement recommendations to senior leadership
• Champion quality culture throughout the organization through training, mentoring, and knowledge transfer

Documentation and Training

• Ensure all quality documentation meets regulatory requirements and industry best practices
• Develop and deliver training programs on quality systems, regulatory requirements, and audit processes as needed
• Maintain current knowledge of evolving regulatory requirements and industry standards, communicating impacts to relevant stakeholders

Required Qualifications

Education and Experience

• Bachelor's degree in Engineering, Life Sciences, or related technical field; Master's degree preferred
• Minimum 10-12 years of progressive quality assurance experience in medical device, pharmaceutical, or highly regulated manufacturing environment
• Extensive hands-on experience with ISO 13485 Medical Device Quality Management Systems
• Comprehensive knowledge of 21 CFR Part 820 (FDA Quality System Regulation) requirements and implementation

Technical Expertise

• Proven track record in conducting internal and external quality audits, with demonstrated ability to identify system gaps and drive corrective actions
• Advanced supplier quality management experience, including supplier auditing, qualification, and performance monitoring
• Strong understanding of risk management principles and application of ISO 14971
• Experience with design controls, document control, management responsibility, and other core QMS elements
• Knowledge of additional regulatory standards such as ISO 17025, ISO 9001, and international medical device regulations (MDR, Health Canada, etc.)

Professional Certifications

• Lead Auditor certification for ISO 13485 required
• ASQ Certified Quality Auditor (CQA) or similar professional certification preferred
• Additional quality-related certifications (Six Sigma, Lean Manufacturing) advantageous

Core Competencies

• Exceptional analytical and problem-solving skills with attention to detail
• Strong leadership capabilities with experience managing cross-functional projects and teams
• Excellent written and verbal communication skills, with ability to present complex technical information to diverse audiences
• Proficiency in quality management software systems and statistical analysis tools
• Demonstrated ability to work independently while managing multiple priorities in a fast-paced environment

Preferred Qualifications

• Experience with FDA 510(k) submissions, PMA processes, or other regulatory submissions
• International regulatory experience with CE marking, Health Canada, or other global markets
• Background in product development within medical device industry
• Experience with software as medical device (SaMD) quality requirements
• Familiarity with cybersecurity requirements for medical devices