Summary of the Position

The Senior Director of Quality Assurance is responsible for the development and maintenance of the EBR Quality System, ensuring company activity is performed in compliance with the EBR Quality System, FDA QSR, and any other relevant international quality system requirements (such as ISO 13485) through both hands-on work and mentoring of direct and indirect reports. 

S/he will lead and set objectives and priorities for a team of quality engineers, quality system specialists, and quality technicians, be a hands-on contributor, and communicate with all levels of the organization. S/he will interact with other EBR departments to ensure timely resolution of product related issues. 

Essential Duties and Responsibilities

• Establish quality standards by authoring and implementing procedures in compliance with all relevant regulations.
• Establish and ensure quality compliance of suppliers, quality system, documentation, corrective and preventive actions, training etc.
• Establish and ensure active involvement of the quality engineering function in all product development, operations, and complaint investigation activities.
• Establish inspection methods and procedures.
• Establish standards for the disposition of finished and nonconforming material.
• Establish and enforce quality documentation standards.
• Provide quality assurance support for all projects impacting or utilizing the quality system. Maintain a clear boundary for business processes that should and should not be governed by the quality system.
• Support cross-functional departments to facilitate the achievement of corporate goals, assisting Operations with efficient manufacturing, collaborating with R&D with expedient product development, and interfacing with Regulatory Affairs for proper medical device reporting.
• Develop and assess quality metrics. Report quality performance via management review to the management team.
• Lead, motivate, and manage the performance of the quality team.
• Serve as management representative for the quality system. Maintain a professional and credible image with regulatory agencies and notified bodies.
• Ensure all product development and manufacturing activity comply with FDA and ISO regulations.

Other Duties and Responsibilities

• Foster cross-functional communication between the quality organization and other departments.
• Work closely with vendors and contract manufacturers to resolve production issues and ensure purchased materials and components meet specifications.

Education and Experience 

• BS in life sciences, engineering, or equivalent 

Required

• Minimum of 10 years related experience in the medical device industry 
• Minimum of three years of management experience in quality engineering or quality systems at a medical device company
• Working knowledge of US and ISO quality system standards and regulations
• Working knowledge of statistical techniques related to sampling and data analysis

Preferred

• Prior experience working with class 3 medical devices preferred

Knowledge, Skills, and Abilities

• Ability to write and edit concise procedures and technical documentation.
• Ability to exercise good judgement in the development of quality systems, requirements, and business processes that are appropriately tuned for the maturity level of EBR Systems
• An undying commitment to find the simplest and most efficient methods for cross-functional teams to comply with quality requirements. A willingness to take ownership and responsibility in assisting other departments in their compliance efforts.
• Proficiency with Microsoft Windows and Office required. Strong preference for familiarity with MasterControl or equivalent eQMS.
• Ability to work independently, take initiative, employ analytical abilities, and lead a team to accomplish both short-term projects and long-term initiatives with minimal direction.
• Self-motivated and self-directed; conscientious approach to work assignments; enjoys the challenges of multitasking and working at a fast pace while staying flexible to frequently shifting priorities.
• Excellent communication skills, both verbal and written.
• Excellent interpersonal and negotiating skills; ability to maintain good working relationships while dealing with a variety of personnel.
• Regular and punctual attendance and dependability in meeting commitments and deadlines.
• Must be available and willing to work flexible schedules, as needed

 Disclaimer:  EBR Systems Inc. will never ask for personal identifying information (such as Social Security Number, bank account details, or credit card information) during the application process. All communication from EBR Systems Inc. regarding job opportunities will be conducted through official company channels.   

Salary Range

$187,000 - $253,000

Base pay is one part of your total compensation. The final starting salary offer to the successful candidate will be determined by evaluating several factors, such as education, experience, knowledge, skills, internal equity, and alignment with market data. 

EBR Systems, Inc. does not accept unsolicited resumes from headhunters, recruitment agencies, or fee-based recruitment services. Please refrain from solicitations at this time.

About EBR Systems

Silicon Valley's EBR Systems is revolutionizing cardiac rhythm disease treatment with its WiSE™ CRT System technology, eliminating the need for pacing leads. Our dedicated team is committed to providing safe, cost-effective wireless cardiac stimulation therapies for millions of patients.

EBR Systems offers a great place to work as well as generous benefits and growth opportunities:

• Medical, dental, and vision insurance
• 401K
• PTO – starting at 3 weeks per year
• Competitive salary with opportunities for career growth
• Employee stock options
• Life insurance
• Weekly company lunches and occasional happy hour events