Quality Manager Jobs

Six Month Goals

• Work with R&D to establish product V&V plans and prioritize execution to support Clinical Trials with a risk-based approach
• Partner with R&D to progress on human factors deliverables such as Use FMEA and formative studies on Sample Preparation
• Drive hazard analysis and other risk management activities to completion
• Champion process validation efforts and help develop process validation master plans for consumables and instruments

How You Will Contribute

• Address Supplier Quality issues related to vendor performance, including working with contract manufacturers
• Lead and develop Quality team members
• Oversee the quality aspects of the consumable assembly and BSL-2 lab areas
• Manage Internal and Supplier Audits and prepare for 3rd Party Audits
• Develop, refine, maintain, and deploy the Quality Management System (QMS)
• Train the organization on procedures and overseeing the Training function
• Ensure Document Controls and activities
• Provide strategic leadership, reporting, and support with Change Control, Material Review, assessing QMS effectiveness, risk management

We'd Love to Hear from You If You

• Value effective people management and developing team members as demonstrated through a history of training and mentoring teammates
• Understand technical details in design and manufacturing of electro-mechanical, software-driven medical devices
• Have worked with medical products in early-stage, clinical, and commercial stages
• Communicate clearly and cohesively across disciplines, including utilizing persuasion and data storytelling techniques
• Balance business needs and start-up uncertainties with quality concerns and regulations
• Are adaptable, flexible and self-driven to find creative solutions to addressing quality issues in a new product

Desired Knowledge, Education, and Experience

• FDA regulations related to IVD medical device development and production, particularly 21 CFR 820
• Product safety regulations such as IEC-61010
• ISO 13485
• B.S. in an engineering or life sciences discipline and at least 5 years in a quality-related role handling activities like risk management, supplier quality, change control, and Quality Management Systems

• Health insurance
• The opportunity to make a global impact
• 401k Matching
• Paid Time Off