Staff Quality Assurance Specialist

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