Director, Quality Assurance at Think Surgical

JOB SUMMARY

The Director, Quality Assurance will plan and direct the establishment, implementation and maintenance of quality assurance standards, ensuring the delivery of high-quality products and robust processes in compliance with both national and international requirements. This position is based in the Fremont, CA office. 

DUTIES & RESPONSIBILITIES

• Serve as the QSR/ISO Management Representative; serve as primary liaison with FDA, California State Department of Health and Notified Bodies during company inspections. 
• Ensure that post-marketing adverse event fillings to foreign regulatory authorities are consistent with company policies, as well as the respective foreign regulatory requirements.
• Lead the Quality system within THINK Surgical, as an effective cross functional member of the management team.
• Implement and maintain programs and processes to ensure high quality products and compliance with the QSR and ISO 13485.
• Develop and implement quality assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements.
• Hire, develop and mentor employees to create a world class Quality Organization. 
• Work directly with and/or influencing other departments to ensure that the quality system program is robustly effective across the organization while ensuring Company compliance and success.
• Lead in the identification, development, implementation and continual improvement of quality systems across the company. 
• Generate and maintain the quality policy, quality manual and quality objectives. 
• Direct and/or participate in work with Design Engineering teams on risk management and design control activities in support of new or next generation products. 
• Develop and administer department budgets, objectives, schedules, training plans and performance reviews.
• Other tasks as assigned.

SUPERVISORY RESPONSIBILITIES

• Recruit, interview, hire, and train new staff in the department.
• Oversee the daily workflow of the Quality Assurance (QA) department.
• Provide constructive and timely performance evaluation and feedback.
• Handle discipline and termination of employees in accordance with company policy.

QUALIFICATIONS

Required:

• B.S. in life sciences, engineering, or equivalent experience.
• 10+ years related experience in the Class II, Class III medical device industry.
• 5+ years in a management role.
• Proficient in 21CFR 820 and EU MDR.
• Thorough knowledge of FDA Quality System Regulation, ISO 13485, ISO 14971, and EU Medical Device Regulation requirements.
• Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
• Experience with ISO 62304, Medical Device Software – Software Life Cycle processes.
• Familiar with EN 60601, safety requirements for medical electrical systems.
• Familiar with IEC 62366, medical device usability.
• ISO 13485 Lead Auditor training.
• Solid organizational, analytical and problem-solving skills.
• Excellent interpersonal and communication skills, both verbal and written.
• Ability to analyze and interpret standards, technical procedures, professional journals and governmental guidance and regulation documents.
• Direct interaction with FDA reviewers/inspectors.
• Working knowledge of MDR/ Vigilance Reporting.
• Team based work environment experience with leadership of teams.
• Strong interpersonal, written, oral, communication, organizational and planning skills.

Preferred:

• Additional peripheral experience in Manufacturing, Engineering and/or Product Development.

COMPETENCIES

• Decision quality
• Drive results
• Organizational savvy
• Drive vision and purpose 
• Effective communication and collaboration
• Strategic mindset
• Build effective teams
• Persuade
• Situational adaptability   

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 20%).

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