OBJECTIVE OF THE POSITION:

The Design Quality Engineer II collaborates with other staff on the product design, research and development, marketing and manufacturing teams to create highly functional products or services that are aligned with the company’s goals and mission.

This position manages 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. The Design Quality Engineer II is responsible for supporting product development teams in the design practices and risk and hazard management processes associated with development of specimen collection kit, assays, diagnostic test services and software algorithms per the Quality Management System (QMS).

The Design Quality Engineer II is responsible for ensuring that a product meets the company's standards and the specifications in each product lifecycle. This position will collaborate with the design and production teams on various design projects. In addition to being a good communicator, all candidates should be creative thinkers with excellent problem-solving skills.

RESPONSIBILITIES:

·Apply Design Controls Management knowledge to product design and phase gate reviews, as well as Design History File (DHF) updates, by reviewing and approving technical documentation such as design and development plans, artwork and labeling, validation/verification protocols, reports, and records.

·Review and approve New Product Development project deliverables, as well as product optimization deliverables, for compliance, completeness, and consistency, with a focus on “Design for Quality.”

·Acting Quality function for product optimization and development core teams responsible for documenting the design process and presenting progress reports to all relevant stakeholders.

·Generate and maintain risk documentation, including, but not limited to Hazard Assessments, Risk Assessments, and Risk Reports, and be a strong contributing team member to Failure Mode and Effects Analyses (FMEA’s).

·Assist in the development of statistically rationalized component and product acceptance inspection plans.

·Analyze data using tools such as Capability Analyses/Studies, SPC, and trend analyses to update inspection plans and control plans.

·Evaluating design plans to comply with industry standards and regulations.

·Maintain existing quality records and designs including development and maintenance of all product DHFs.

·Assist in the development of Quality Management System (QMS) processes and procedures to ensure compliance with applicable design control and product development regulations.

·Perform data analysis, and develop, monitor, and oversee metrics reporting.

·Lead and/or support continuous improvement activities.

·Support and participate in internal and external audits and inspections.

·Generate and maintain procedures, work instructions, inspection plans, forms, and templates.

·Lead and/or participate on Corrective Action and Preventive Action (CAPA) investigations.

·Review/approve verification & validation protocols and reports.

·Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

·While performing the duties of this job, the team member is regularly required to use hands to grip, handle, or feel objects, tools, or controls and talk or hear.

·The team member frequently is required to sit, walk, and reach with hands and arms; occasionally is required to stand, stoop, kneel, crouch, or crawl, and must occasionally lift and/or move more than 25 pounds.

·Specific vision abilities required by this job include visual acuity to Colorado driver’s license requirements.

WORK ENVIRONMENT:

·The work environment characteristics described here are representative of those a team member encounters while performing the essential functions of this job.

·Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

·The primary work environment is an office setting.

·The noise level in the work environment is usually moderate.

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