Quality Assurance Technician

  Alameda, CA              ·            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 Quality Assurance Technician who is highly motivated and passionate to engage and help drive collaborative, quality-focused design, development, and production of novel Class III active implantable devices.

The Quality Assurance Technician will be expected to:

• Perform incoming inspections of raw materials and finished goods, including Device History Record reviews, per iota specifications
• Use various tools (calipers, micrometers, pin gages, vision systems) to perform complex (GD&T governed) dimensional AQL and First Article Inspections
• Maintain clear material status identification and execute transactions in the ERP system
• Perform and document internal equipment calibrations, preventive maintenance, and commissioning/decommissioning activities as required
• Work with external suppliers to schedule equipment calibration and preventive maintenance activities (including RFQs, pick-up/drop-off, and list maintenance)
• Process Returned Goods Authorization requests from customer sites, including decontamination, quarantine, and initial assessments per established procedures
• Initiate Non-Conforming Reports and segregate material/equipment for identified non-conformities. Follow up with owners as required
• Assist with ECO material dispositions for areas of responsibility
• Create redlines and route change orders to improve general quality system documentation including but not limited to specifications, forms, templates, and work instructions
• Support Purchasing, Supplier Quality, Manufacturing, and R&D with operational quality issues to ensure production timelines are met
• Support regulatory audits for areas of responsibility

Qualifications:

• High School Diploma with three plus years of relevant experience in the Medical Device Industry (prior experience with Class III Devices preferred)
• Experience interpreting complex engineering drawings with GD&T and selecting appropriate inspection tools
• Proven ability to maintain manufacturing and test equipment per GMP guidelines
• Experience with the use of ERP and eQMS systems
• Knowledge of ISO 13485:2016 and FDA 21 CFR Part 820
• Working knowledge of Gage RR principles
• Excellent communication (verbal and written) and collaboration skills
• Organized, self-motivated, and able to effectively manage multiple priorities
• High attention to detail

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

Please click here to apply.