Job Details

Overview

Join to apply for the Director, Quality Assurance role at THINK Surgical. This range is provided by THINK Surgical. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$200,000.00/yr - $225,000.00/yr

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%).

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.

Additional

• Seniority level: Director
• Employment type: Full-time
• Job function: Quality Assurance
• Industries: Medical Equipment Manufacturing

Referrals increase your chances of interviewing at THINK Surgical by 2x