Manager - Quality Engineering

The Manager - Quality Engineering will have broad and critical responsibilities that include: overseeing quality policies, procedures, processes, programs, and practices associated with product realization activities (including pre and post launch), and documentation to demonstrate conformance with appropriate standards and regulations; supporting product development teams in the design practices and risk and hazard management processes associated with development of medical devices, assays, and diagnostic test services per the Biodesix Quality Management System (QMS); managing the Quality Engineering group and accountable for applicable quality systems, including but not limited to Product Development, Change Control, Risk Management, Supplier Management, and Materials Management

Key Responsibilities 

• Day-to-day management, development, and implementation of quality assurance programs by the Company. 
• Deliver against Company goals to ensure core team projects are completed on time and meet the Company's quality standards. 
• Manage the Quality Engineering Team and associated systems and personnel 
• Strong collaboration with operations, managers, and product development staff. 
• Monitor production and purchasing services or activities to improve accuracy, customer service, or safety.  
• Development of validation plans for equipment, process, and devices.  
• With Operations and Development leadership, examine existing procedures or opportunities for streamlining activities to meet product improvement needs. 
• Contributor as the Quality function on verification & validation plans and reports. 
• Leading the development of the risk management plan(s) for product realization. 
• Assisting project teams on compliance with design requirements per CAP/CLIA, NYS CLEP and FDA QMSR, European MDR/IVDR, ISO 13485, ISO 14971, and other applicable ISO/EN standards as applicable to the Company. 
• Accountable for the following key functions within the Quality team Product Development Process: Design Control SOPs, Device Design History Files, Change Control, Risk Management, Quality/Process Improvement and Validation, Supplier and Material Management, Operational processes that impact quality 
• All other duties as assigned 

Management Responsibilities 

• Leads a team of employees  
• Sets team strategy, priorities, and performance expectations aligned to organizational goals 
• Drives talent development, succession planning, and workforce planning 
• Provides ongoing feedback and conducts performance evaluations 
• Promotes a culture of respect, collaboration, and belonging across the team and broader organization 

WHAT YOU'LL BRING:

• Knowledge and experience with (CAP/CLIA, NYS CLEP), ISO 13485, LDT, QMSR and Product Development. 
• Experience developing or reviewing product, equipment, or process verification and validation plans and reports.
• Clear understanding and experience implementing ISO 14971:2019 Risk Management into a QMS. 
• Previous experience in leading and participating in Product Development teams. 
• Previous experience in managing and growing teammates. 
• Working knowledge of developing equipment and/or process master validation plans. 
• Must be a team player with strong customer orientation and ability to work within a diverse disciplinary cross-functional team environment. 
• Strong verbal, written, organizational, time management and interpersonal skills. 
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. 
• Must be able to communicate effectively in a verbal and written format. 
• The successful candidate will be: 
  • Able to perform all the required skills of this position with minimal direction. 
  • A detail oriented and quality minded individual with experience based good judgment. 
  • Strong computer skills, including working knowledge of MS Office and e-mail. 

We want you to have a clear view of the Manager - Quality Engineering role—and we want to get to know the real you. Our interview process is designed to be thorough, transparent, and give you direct insight into what it’s like to work here:

1. Virtual Recruiter Screen – A conversation to understand your background, what motivates you, and where you're looking to grow.
2. Hiring Manager Interview – A deeper discussion about your experience, skills, and approach.
3. Final On-Site Interview – Tour our corporate headquarters; interview with additional members of the team to discuss alignment and fit.