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Quality Manager

LightDeck Diagnostics

This is a Full-time position in Boulder, CO posted September 12, 2021.

LightDeck Diagnostics believes in a new approach to healthcare where fast, accurate, simple, low-cost diagnostic tests will be run wherever and whenever they are needed, without compromise.

Our proprietary LightDeck® platform combines an advanced laser waveguide with novel materials and patented manufacturing techniques to deliver lab-quality results anywhere, in minutes.

We are introducing a portfolio of in vitro diagnostic panels.

The first are point-of-care tests for COVID-19.

The LightDeck platform is currently commercialized in veterinary diagnostics and for environmental testing.
Job Summary
The Quality Manager position will lead complex quality work of a broad nature.

The QM will apply knowledge of applicable regulations, standards, principles, theories, and concepts to ensure compliance of LightDeck’s quality system procedures and processes.

This position will support QMS operation for effective, efficient compliance and in support of high-quality product.
Primary Responsibilities Leadership Lead and mentor team of quality assurance team including quality engineers and document control specialists Ensure consistent voice from quality team Manage culture to ensure collaborative, supportive relationships between quality and other departments Lead audits with 3rd party auditing organizations, notified bodies, customers, and other relevant parties Coordinates interdepartmental activities Lead investigations and resolve potential product quality issues to improve efficiency.

Promote quality within the organization and communicate the importance of meeting customer and regulatory requirements QMS – lead on-going efforts to implement, maintain, and grow quality management system processes to ensure quality products and compliance to ISO 13485 2016/ MDSAP and other applicable standards and regulation.

Management Review – Conduct Management Review meetings and support other KPI assessments as requested.

CAPA – oversee Corrective Action / Preventive Action (CAPA) process for systemic issues, complaints, etc.

Ensure team is driving root cause investigations and completion according to target implementation date and without undue delay.

NCMR – oversee Non-Conforming Material Reports (NCMRs) program for out of specification parts, sub-assemblies, and assemblies.

Support and monitor timely disposition of materials.

Internal Audits – lead Internal Audit program, review and address results as appropriate.

Test Method Development and Inspections – use knowledge of inspection methodologies to design and provision resources for incoming, in-process, and final inspections.

Document and Record Control – work with engineering, scientific, and production teams to develop DMR, DHF, and DHR documentation.

Design and Development – ensure quality objectives and deliverables are achieved during design and development efforts.

Risk Management – lead risk management processes, including hazard analyses or FMEAs.

Ensure risk management efforts are occurring to plan.

Supplier Controls – coordinate supplier control activities such as supplier audits, assess supplier performance.

Production Controls – work with production team to implement and maintain production controls.

Process Validation – review process validation protocols, participate in execution of protocols, and report on results.

Equipment PM and Cal – work with other QA team members to ensure equipment program is compliant.

Software Tool Validation – draft software requirements, protocols, and reports for software tools used in manufacturing processes.

Training and Competence – provide training on QMS topics, ensure training programs are occurring as planned.

Post Market Surveillance – participate in Post Market Surveillance planning and execution.
Requirements
Knowledge, Skills and Abilities (KSAs) Proven working experience In a quality leadership role, preferably within the IVD or medical device industry In depth knowledge of ISO 13485 2016 standard, MDSAP, and FDA, Canadian, and EU IVD regulations Experience related to the above listed Job Duty categories Proficient and experienced in spreadsheets, MS Office, statistical software, and other QMS software applications.

Outstanding technical writing and communication skills Leadership qualities including team development, project management, and culture maintenance Education and Experience Requirements
Bachelor’s Degree in engineering, science, or other related technical field A minimum of 7+ years of quality assurance experience, preferably in IVD or medical device industry Experience in a leadership role, preferably in quality assurance Or equivalent combination of education and experience Recognized quality certification (e.g., CQE) preferred, but not essential
Working Conditions
Work will normally be performed in an office environment and will involve sitting, standing, lifting up to 10 pounds, utilizing phone and computer equipment.
LightDeck Diagnostics is an Equal Opportunity Employer committed to a culturally diverse workforce and is an Affirmative Action Workplace.

We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

LightDeck is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures.

If you need assistance due to a disability, you may contact us at jobs@lightdeckdx.com.
Applicants must have authorization to work in the United States and must apply through our Career Site (unless the candidate requires assistance due to a disability as indicated above).

No phone calls, please.
Benefits
Hiring salary for this position is $85,000 to $120,000 annually.

Our organization of ~100 people works on proprietary technology that has the potential to have a huge impact on the world (see recent press release on our website).

Company benefits include medical, dental, vision, disability, simple IRA with company match, PTO, paid holidays, as well as a casual and collaborative work environment, office snacks and drinks.

Located near Boulder’s many bike trails, our employees often bike or walk to work.

We are committed to work life balance, and seek to support our employees with professional development opportunities that expand their skills and abilities.

Come join the LightDeck team today and make a difference!