Quality Engineer II

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 LightDeck’s quality system procedures and processes. This position will support QMS SOP development for effective, efficient compliance and in support of high-quality product.

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, ISO 9001:2015 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. Lead 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. Lead Material Review Board (MRB).
• Internal Audits – perform Internal Audits, as assigned, and address results as appropriate.
• Test Method Development and Inspections – use knowledge of inspection methodologies to evaluate the design and performance 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. Represent Quality Assurance on development project teams.
• 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.
• Perform other related duties as assigned.

Requirements

• Bachelor’s Degree in engineering, science, or other related technical field
• A minimum of 4-7+ years of quality assurance experience, preferably in a regulated industry or equivalent combination of education and experience
• Proven working experience as a quality engineer, preferably within a regulated industry; recognized quality certification (e.g., CQE) preferred
• Working knowledge of ISO 9001:2015 standard preferred
• Working knowledge of ISO 13485:2016 standard a plus
• Working knowledge of FDA, Canadian, and EU IVD regulations
• Experience related to the above listed Job Duty categories, with emphasis on Design and Development and Validation, preferred
• Proficient and experienced in spreadsheets, MS Office, statistical software, and other QMS software applications.
• Outstanding technical writing and communication skills. Ability to work with all levels of the organization.

Benefits

Benefits include Medical, Dental, Vision, 401k and a generous leave program.

Work will be performed in both an office and a laboratory environment. Office setting will involve sitting and standing, lifting up to 10 pounds, utilizing phone and computer equipment. LightDeck laboratories handle biohazards and potentially infectious, human-derived samples such as blood products. Laboratory personnel will be trained to work in Biosafety Level 2 laboratory settings and are required to follow all safety protocols and PPE requirements. Lab process equipment may include analyzing and testing tools and the usage of chemicals and reagents. Lifting/carrying up to 25 pounds and process monitoring via visual inspection. 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 appli