JOB SUMMARYThe Manager, Quality Assurance is responsible for leading and ensuring the effective execution, compliance, and continuous improvement of core Quality Management System (QMS) processes, including Corrective and Preventive Action (CAPA), Complaint Handling, Nonconformance Management, Internal and External Audits, and overall regulatory compliance. This role provides operational and strategic leadership to ensure that quality system processes are compliant with applicable regulatory requirements, including FDA Quality Management System Regulation (21 CFR Part 820/QMSR), ISO 13485, and other global standards. The Manager, Quality Assurance is accountable for driving timely and effective investigations, risk-based decision making, and inspection readiness across the organization. The position leads a team of quality professionals and works cross-functionally throughout the organization to ensure product quality, patient safety, and regulatory compliance. This position is based in THINK's corporate office.
DUTIES & RESPONSIBILITIES- Lead and manage the CAPA, Complaint Handling, Nonconformance, and Audit programs to ensure compliance, effectiveness, and continuous improvement.
- Ensure quality system processes are aligned with FDA (21 CFR Part 820/QMSR), ISO 13485, and other applicable regulatory requirements.
- Establish and maintain a risk-based framework for escalation, prioritization, and resolution of quality issues across CAPA, complaints, and nonconformances.
- Drive timely and thorough investigations, including root cause analysis, correction, corrective action, and verification of effectiveness (VOE).
- Oversee complaint handling processes, ensuring accurate evaluation, investigation, and regulatory reporting (e.g., MDR) as required.
- Ensure nonconformances (material and process) are appropriately documented, evaluated, and dispositioned, with clear escalation pathways to CAPA when required.
- Serve as the subject matter expert (SME) for CAPA, complaints, nonconformance, and audit processes.
- Ensure processes incorporate risk-based decision making consistent with QMSR expectations.
- Ensure alignment and integration across quality system processes to avoid silos and drive systemic effectiveness.
- Lead internal audit programs, including audit planning, execution, reporting, and follow-up of audit findings.
- Support external audits and inspections (FDA, notified bodies, customers), including preparation, hosting, and response activities.
- Ensure inspection readiness through robust documentation, metrics, and process discipline.
- Develop and monitor key quality metrics (e.g., CAPA timeliness, complaint cycle time, audit findings, backlog trends) and drive data-driven decision making.
- Identify systemic quality issues and drive cross-functional continuous improvement initiatives.
- Ensure effective implementation and maintenance of quality system procedures, work instructions, and records.
- Collaborate with cross-functional teams to ensure compliance with product and process requirements.
- Provide leadership in regulatory compliance strategy as it relates to quality system processes.
- Support management review by providing meaningful data, trends, and recommendations.
SUPERVISORY RESPONSIBILITIES- Direct management of Quality Assurance personnel, including Compliance, Complaints, Supplier Quality, Quality Engineering, and Inspection functions.
- Provide coaching, mentoring, and performance management to ensure a high-performing team.
- Establish clear roles, responsibilities, and accountability within the team.
- Handle discipline and termination of employees in accordance with company policy.
- Drive a culture of quality, compliance, and continuous improvement across the organization.
- Ensure adequate resourcing and prioritization aligned with business and regulatory needs.
QUALIFICATIONSRequired:- Bachelor's degree in engineering, science, or a related discipline, or an equivalent combination of education and experience.
- Minimum of 10 years of experience in Quality Assurance within the medical device or similarly regulated industry.
- Minimum 3 years of leadership or people management experience.
- Strong working knowledge of FDA 21 CFR Part 820/QMSR and ISO 13485 requirements, along with direct experience managing CAPA, complaint handling, nonconformance, and audit processes.
- Experience supporting FDA inspections and/or notified body audits is required.
- Proven ability to lead complex investigations, perform robust root cause analysis, and drive effective corrective actions.
- Experience developing and monitoring quality metrics, as well as driving continuous improvement initiatives.
- Strong written and verbal communication skills are essential, along with excellent organizational, analytical, and problem-solving abilities.
- Ability to influence cross-functional stakeholders and drive accountability across the organization is critical for success in this role.
- Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
Preferred:- Professional certifications such as Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or ISO 13485 Lead Auditor.
- Experience working with medical device software, robotics, or other complex systems.
- Experience implementing or transforming Quality Management System processes.
- Familiarity with Salesforce.com based electronic QMS platforms such as Propel.
COMPETENCIES- Decision quality
- Leadership and team development
- Risk-based thinking
- Process optimization
- Collaboration and cross-functional Influence
PHYSICAL DEMANDS & WORK ENVIRONMENT- Must be able to remain in a stationary position and operate office equipment for a prolonged period of time.
- Physical activities include, but not limited to constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs.
- Other infrequent physical activities include, but not limited to, positioning self to complete assigned tasks, and ascending/descending floors and/or ladders.
- Occasionally work around moving mechanical parts.
- Must be able to work in a schedule that commensurate with business operation, including work during weekends, holidays and/or times outside of normal business hours.
- Must be able to travel as business necessitates (up to 10%).
Disclaimer:The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be possible to enable individuals with disabilities to perform the essential functions.
