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 Supplier Quality Engineer located in a commutable location to Alameda and the greater San Jose, CA area, who is highly motivated and passionate to engage as a quality core team member on collaborative, quality focused design and development of novel Class III active implantable devices. The Senior Supplier Quality Engineer will be expected to: 

•Take a lead position to facilitate the implementation of the iota production processes at our outsourced production suppliers

•Interact with core internal groups to review and confirm all supplier facing design outputs are met and ready for transfer to suppliers

•Execute supplier facing design output transfer to outsourced suppliers and integration into their QMS

•Verify the outsourced production suppliers is capable of implementing design outputs (i.e. CTQs, and test methods)

•Experience writing, reviewing, and implementing part specifications and receiving inspection plans with focus on CTQs

•Generate supplier performance matrixes and present opportunities and threats to the company, product, and QMS

•Generate, monitor, and close Supplier Corrective Actions Requests (SCAR) in a timely manner

•Develop, modify, apply, and maintain SOPs and other processes and procedures to ensure compliance to requirements and guidance 

•Lead and drive CA & PA (Corrective and Preventative Action) projects that are attributed to suppliers as required

•Drive quality improvement projects to include compliance to new or updated requirements or guidance documents

•Ensures that activities are complaint with policies and procedures

 Minimum Qualifications: 

•Bachelor's degree in Engineering, Science, or related technical degree

•Five minimum years of relevant experience.

•Three years Class III Medical Device experience

Preferred Qualifications: 

•Technically savvy; must be able to understand specifications and requirements regarding an array of engineering disciplines and technical issues

•Organized, self-motivated, ability to effectively manage multiple projects and priorities; high attention to detail 

•CQA, MDSAP Lead Auditor Certification or demonstrated compliance auditing experience

•Enhanced understanding of ISO 13485, 14971, and 21 CFR 820 Regulatory requirements

•Demonstrated application of ISO 13485, 21 CFR 820, and ISO 14971 principles with internal and external customers and suppliers

•Ability to travel both domestically and, when needed, internationally

•Effective interpersonal/communication skills 

•Green belt or higher Six Sigma certification

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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:

Health

Employees thrive when healthy, both physically and mentally:

Comprehensive health coverage for you and your family, covered at 100%

Employee Assistance Program

Time-off

Take time off when you need to take it:

Generous PTO policy

Paid parental leave

Paid holidays beyond the traditional

Paid volunteer day

Competitive Compensation

In addition to our competitive base salaries, we offer:

Annual Bonus Plan

Long Term Incentive Plan (LTIP)

401k plan with matching contributions equal to 100% of your deferral contributions up to 5% of your eligible compensation