Supplier Quality Engineer
Seattle, WA, USA
Posted on Wednesday, August 16, 2023
Who We AreTasso is a fast-growing Seattle-based startup that delivers at-home diagnostic testing to those who need it most. Tasso was founded to find a better way to collect blood than a painful fingerstick or time-consuming venous draw. Since then, our products have been used in pharmaceutical clinical trials, by Olympians as part of a new virtual anti-doping program, and broadly by hospital systems across the US. We are growing our footprint with leading health systems, clinical research organizations, academic medical centers, and more who are looking to deliver clinical-grade, convenient diagnostic tests to their patients. You Will:
- Review manufacturing specifications to identify materials needed for production.
- Support identifying and sourcing the best vendors to supply materials needed for production.
- Visit supplier facilities and observe the manufacturing environment to review and assess their procedures.
- Perform regular quality control audits to ensure suppliers continue to work in compliance with established standards.
- Support review of incoming materials from suppliers to check for defects and ensure quality.
- Conduct tests and assessments on products and materials to identify quality issues.
- Establish key performance indicators to track ongoing supplier performance.
- Maintain detailed reports on supplier quality, including defect rates and areas that result in potential nonconformances.
- Provide technical advice and guidance to suppliers to reduce defect rates.
- Serve as a liaison between Tasso management and supplier to identify and resolve quality issues.
- Assess and communicate internal specification changes to suppliers and partners with purchasing to manage phase-in and phase out activities.
- Assess the impact of proposed external supplier changes to product quality and manage phase-in of approved changes.
- Maintain supplier qualification records.
- Work in cross-functional teams to improve processes that cross department boundaries.
- B.S. in Engineering, Technology, or Science from an accredited college or university.
- 5+ years of experience in Medical Devices, Manufacturing, and Quality Assurance.
- FDA 21 CFR 820, ISO 13485, ISO 14971, and cGMP in a fast-paced manufacturing environment.
- Excellent leadership, interpersonal, and liaison skills are a must.
- Strong statistical analysis and quality assurance background.
- Experience with manufacturing and production processes and engineering principles.
- Ability to provide guidance to improve process efficiency.
- Electronic Quality Management System experience.
- Proficiency in Word and Excel.
- $100,000 - $125,000 per year base salary + Stock Options
- 100% paid Medical, Dental & Vision for employees and generous subsidy for dependents
- 11 Paid Holidays and unlimited PTO
- 401K + Employer Match
- Paid parental leave policy
- Flexible work hours and a hybrid on-site policy