Manager - Quality Engineering

Biodesix, Inc.; Louisville (CO); On-site; USD 100,000 - 116,000; Full time

Benefits offered by this job

Discretionary Bonus

Health Coverage (Medical, Dental, Vis

Vacation 120 hours

Sick time 72 hours

11 holidays + 3 floating

Employee Assistance Program

Voluntary Benefits

Recognition program

Job summary

Biodesix is seeking a Manager - Quality Engineering in Louisville, CO, a hybrid role that leads quality policies, processes, and documentation across product realization from development to post-launch.

You will guide the Quality Engineering team, ensure conformance with CAP/CLIA, NYS CLEP, ISO 13485, and FDA QMS standards, and collaborate with operations and development to improve product quality and regulatory compliance.

Qualifications

• Experience with CAP/CLIA, NYS CLEP, ISO 13485, and FDA QMS.
• Proven ability to lead and grow a Quality Engineering team.
• Strong understanding of risk management in medical device development.
• Experience with design controls and validation plans.
• Excellent communication and cross-functional collaboration.

Responsibilities

• Oversee QA programs across product realization.
• Lead QMS, Change Control, Risk Management, Supplier and Material Management.
• Head development of risk management plans.
• Coordinate with operations and development for process improvements.
• Manage team performance and staffing.

Skills

Quality Engineering

CAP/CLIA Knowledge

ISO 13485

Risk Management

Leadership

Cross-functional collaboration

Regulatory Compliance

Documentation

MS Office

Job description

ABOUT US:
Biodesix is a leading diagnostic solutions company, driven to improve clinical care and outcomes for patients.

Biodesix Diagnostic Testssupport clinical decisions to expedite personalized care and improve outcomes for patients with lung disease.

Biodesix Development Servicesenable the world’s leading biopharmaceutical, life sciences, and research institutions with scientific, technological, and operational capabilities that fuel the development of diagnostic tests, tools, and therapeutics.

Our Mission:Transform patient care and improve outcomes through personalized diagnostics that are timely, accessible, and address immediate clinical needs.

Our Vision: A world where patient diseases are conquered with the guidance of personalized diagnostics.
For more information, please visit www.biodesix.com

This is a hybrid role based in Louisville, CO

THE ROLE:

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

JOB LOCATION: This is a hybrid role based in Louisville, CO

THE ROLE:

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

WHAT YOU'LL DO:

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 Q M SR, European MD R/IVDR , ISO l3485 , 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, Operation al 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, Q M SR and Product Development .
• Good working knowledge of object-oriented concepts and application design principles .
• Clear understanding and experience implementing ISO 14971 :2019 Risk Management into a QMS .
• Previous e xperience in l eading 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.
• Experience with creation and execution of testing plans/reviewing functional specification documents .
• 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.

WHAT YOU'LL GET:

• Annual Base Salary Range $100,000 – $116,000
• Discretionary Bonus opportunity
• Comprehensive health coverage: Medical, Dental, and Vision
• Insurance: Short/Long Term Disability and Life Insurance
• 120 hours of annual vacation
• 72 hours of paid sick time off
• 11 paid holidays + 3 floating holidays
• Employee Assistance Program
• Voluntary Benefits
• Employee recognition program

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:

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

Biodesix is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Biodesix is proud to be an Equal Opportunity Employer

We are committed to ensuring an inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Notice to Recruitment Agencies

In the case of candidates submitted or presented to Biodesix by a recruiter or agency without a signed agreement, Biodesix explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

Accommodation Notice

If you are an individual with a disability and require a reasonable accommodation to use our online system to search and/or apply for a position, please send us an email at [e-mail].

Recruitment Fraud Warning

Biodesix has become aware of individuals fraudulently representing themselves as Biodesix employees or recruiters.

Please be aware that Biodesix will never:

• Extend a job offer without an interview process.
• Conduct interviews solely through questionnaires, email, text messages, or chat platforms.
• Request payment, gift cards, cryptocurrency, banking information, or personal financial information as part of the recruiting process.
• Ask candidates to purchase equipment or software on behalf of the company.

All legitimate Biodesix employment opportunities are posted on our official Careers page. If you receive a suspicious communication claiming to be from Biodesix, or would like to verify the legitimacy of a job opportunity, please contact us at [e-mail].