Senior Quality Auditor

Quality – Quality           ·            1020 Atlantic Avenue, Suite 100 Alameda, Ca 94501 (On-Site)              ·            Full time

iota Biosciences, a wholly-owned subsidiary of Astellas Pharma US, is a medical device company pioneering bioelectronic solutions across a range of medical therapies and diagnostics. Bioelectronic medical implants are the start of an entirely new form of medicine, treating chronic diseases through non-pharmaceutical mechanisms not previously accessible to clinicians.

iota Biosciences, Inc. was acquired by Astellas Pharma US in November 2020. Astellas Pharma US, Inc. is an affiliate of Tokyo-based Astellas Pharma Inc., a top 20 global pharmaceutical research company. Astellas is committed to turning innovative science into medical solutions that bring value and hope to patients and their families. iota’s core proprietary technology stack leverages ultrasonic energy to communicate with and power custom implantable devices, enabling completely new clinical approaches to treating diseases. At iota Biosciences you will be given the opportunity to substantially influence the design and success of these pioneering Class III medical implants, as the company expands the reach of its novel technology while bringing new solutions to the clinic.

We are looking for a Senior Quality Auditor who is highly motivated and passionate to engage as a quality team member building an internal Audit System within the Quality Management System (QMS) for novel medical devices. The Senior Quality Auditor will be expected to: 

• Develop, lead and drive an internal audit program to 21 CFR Part 820, and ISO 13485:2016 compliance.
• Perform gap assessments and internal audits throughout the QMS, and drive actions to address findings.
• Develop, lead and drive a Corrective and Preventative Action system.
• Guide preparation activities, and actively support regulatory body audits, including front and/or back room support.
• Provide Internal Audit process, gap assessment, and compliance trainings to QMS team members on a continuous basis.
• Develop and maintain quality programs, systems, processes (SOPs) and procedures for compliance to regulatory requirements.
• Drive awareness and compliance to applicable standard operating procedures to meet, comply and champion quality commitments.
• Provide expertise and guidance in interpreting policies, regulations, and standards.
• Drive quality improvement projects to include compliance to new or updated requirements or guidance.  
• Lead the development and execution of streamlined business systems, which effectively identify and resolve quality issues and audit findings.
• Collaborate with cross-functional colleagues regarding the impacts of enhancements and process changes.
• Work with team members to provide process oversight on a continuing basis to ensure activities are compliant with requirements and meet regulations.

Key Qualifications

• Bachelor’s degree
• Minimum four years of relevant experience in the medical device field, or an advanced degree with a minimum of two years of relevant experience in the medical device field
• Extensive knowledge of ISO 13485:2016 and FDA 21 CFR part 820 and part 11 regulations
• ISO 13485 Lead Auditor certification
• Minimum 2 years Lead Auditor experience in Medical Device field
• Strong technical writing and documentation review skills
• Strong training skills
• Able to work constructively across all functions of the organization
• Organized, self-motivated, ability to effectively manage multiple projects and priorities; high attention to detail 
• Effective interpersonal/communication skills 

Preferred Qualifications

• ASQ Certified Quality Auditor
• Software and/or process validation experience
• Mentorship experience

Job Type

On-site (flexible), Full-time

$102,000 – $158,000 a year

At iota Biosciences, we take pride in providing equal employment opportunities to everyone, inclusive of race, ethnicity, beliefs, religion, marital status, gender, gender identity, citizenship status, age, veteran status or disability.

iota offers a very competitive benefits package that includes the following:

• 100% employer-paid Anthem Platinum PPO or Kaiser Platinum plans, as well as dental, and vision, for employees and dependents at 100%
• Short-Term and Long-Term Disability
• Employee Assistance Program
• 401k plan – matching contributions equal to 100% of your deferral contributions up to 5% of your eligible compensation
• Bonus Plan
• Long Term Incentive Plan (LTIP)
• Four weeks of vacation, two floating holidays, and nine company paid holidays

Please click here to apply.