Quality Engineer I (In Vitro Diagnostics) - InBios International : Job Details

Quality Engineer I (In Vitro Diagnostics)

Join to apply for the Quality Engineer I (In Vitro Diagnostics) role at InBios International, Inc.

Quality Engineer I (In Vitro Diagnostics)

Join to apply for the Quality Engineer I (In Vitro Diagnostics) role at InBios International, Inc.

DescriptionAre you a detail-oriented problem-solver with a passion for purpose-driven work? Join InBios, a mission-focused biotech company developing and manufacturing diagnostic tools that combat infectious diseases worldwide.

DescriptionAre you a detail-oriented problem-solver with a passion for purpose-driven work? Join InBios, a mission-focused biotech company developing and manufacturing diagnostic tools that combat infectious diseases worldwide.About UsInBios International Inc. has been in business since 1996 designing and manufacturing diagnostic assays for emerging infectious diseases and biothreats. Our work supports global health initiatives and government-funded research, with a strong emphasis on innovation, quality, and compliance. Based in Seattle, we offer a collaborative culture, competitive compensation, and meaningful work that makes a global impact.Location: Seattle, WAType: Full-time | On-siteSalary Range: $75,000 - $110,000 (DOE)What You'll DoAs a Quality Engineer I, you'll be instrumental in upholding the quality and compliance of our in vitro diagnostic products. You'll collaborate with cross-functional teams to ensure our assays meet regulatory standards, perform reliably, and are safe for clinical use. Your strong organizational and communication skills will help foster a culture of quality and continuous improvement across the organization.Key Responsibilities

• Analyze manufacturing processes, identify methods of improving efficiency (while maintaining cGMP), and work with relevant departments to implement changes.
• Identify product failure modes and provide possible solutions through product quality and process improvements.
• Assist in troubleshooting equipment related production issues and implement necessary improvements.
• Integrate hardware and software into new and existing manufacturing equipment.
• Assist with process development efforts during product transition from R&D to Manufacturing.
• Review, author, and/or approve batch records, device history records, deviations, nonconformances, and corrective and preventive actions (CAPA).
• Conduct root cause failure analyses and corrective actions.
• Design and conduct process and equipment evaluations and validations. Perform validation impact assessments.
• Contribute to the qualification, validation, calibration, and maintenance of facilities, utilities, laboratory and manufacturing equipment.
• Assist in other routine Quality Systems tasks as necessary.

What We're Looking ForRequired

• Bachelor's degree (BS) in chemical, mechanical or bioengineering, or related discipline.
• BS with 3+ years relevant experience or MS with 1+ years relevant experience.
• Experience working in a GMP, FDA, ISO and/or USDA regulated environment.
• Experience working with automated manufacturing equipment preferred and common automation systems preferred (ex. vision systems; motion control including, but not limited to, servo motors and stepper drives, human machine interfaces, etc.)
• Strong analytical and statistical analysis skills
• Familiarity in producing CAD drawings (Fusion 360)
• Familiarity in a programming language (preferably Python)
• Experience designing and conducting Installation, Operational, and Performance Qualifications (IQ, OQ, and PQ)

Perks & Benefits

• Medical, dental, vision, life & disability insurance
• 401(k) + Roth IRA + FSA
• 2 weeks paid vacation + 11 paid holidays (including winter break week: Christmas Day through New Year's Day)
• Supportive, mission-driven culture

Apply TodayBe part of a team that's advancing science and improving lives.

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionQuality Assurance

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