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Quality Engineer

  • Anywhere

Company :
LightDeck Diagnostics

Location :
Boulder, Colorado

Expiry Date :
Fri, 26 Mar 2021 23:59:59 GMT

Apply Job :
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Description :
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 is an on-the-spot test for COVID-19. The LightDeck platform is currently commercialized in veterinary diagnostics and for environmental testing.

Job Duties: The Quality Engineer (QE) position will, under limited supervision, perform complex quality work of a broad nature. The QE will apply knowledge of applicable regulations, standards, principles, theories, and concepts to ensure compliance of MBios quality system procedures and processes. This position will support QMS SOP development for effective, efficient compliance and in support of high-quality product. This position reports to the Director of Quality Assurance.

Assignment to and ownership of several of the following areas:

* QMS support on-going efforts to implement and maintain SOPs for compliance to ISO 13485:2016 and other applicable standards and regulation.
* Management Review Supply data for Management Review meetings and other KPI assessments as requested.
* CAPA issue Corrective Action / Preventive Action (CAPA) for systemic issues, complaints, etc. Drive root cause investigations and completion according to target implementation date and without undue delay.
* NCMR issue Non-Conforming Material Reports (NCMRs) for out of specification parts, sub-assemblies, and assemblies. Support and monitor timely disposition of materials.
* Internal Audits support Internal Audit program, review and address results as appropriate.
* Test Method Development and Inspections use knowledge of inspection methodologies to design and perform incoming, in-process, and final inspections.
* Document and Record Control work with engineering 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 host risk management sessions, such as hazard analyses or FMEAs. Ensure risk management efforts are occurring to plan.
* Supplier Controls conduct 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

No single candidate is expected to have demonstrated skill in all functions listed below, but candidates should highlight relevant experience in a brief cover letter.

* Proven working experience

* o As a quality engineer, preferably within the IVD or medical device industry Working knowledge of ISO 13485:2016 standard Working knowledge of 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

Education and Experience:

* Bachelors Degree in engineering, science, or other related technical field
* 1-3 years of quality assurance experience, preferably in IVD or medical device industry
* Or equivalent combination of education and experience
* Recognized quality certification (e.g., CQE) preferred, but not essential

Hiring salary range for this position is $60,000- $90,000(annualized)

Applicant must have authorization to work in the U.S. Resumes must be accompanied by a cover letter explaining how the applicant meets the job requirements and desired skills. Please apply via Workable; or you may email a cover letter and resume to with applicant name and the job title listing in the subject line.

No phone calls, please. Note: no third-party recruiters will be enlisted for this search.

LightDeck Diagnostics is an Equal Opportunity Employer committed to a culturally diverse workforce.

Benefits

Our organization of ~80 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 MBio team today and make a difference!