Quality Engineer - Medical Device

Full Time
Carlsbad, CA 92008
$76,000 - $105,600 a year
Posted
Job description

In our line of work, life isn’t a given - it’s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we’re located. Creating impactful innovations like ours, doesn’t happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career.

Radiometer is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.

You will support the quality engineering function for your two Value Streams. Participate in product development team activities to ensure the manufacturing processes conform to applicable standards. Serve as a technical resource to product development, manufacturing and suppliers to improve process capability, reliability and the quality of products. Create quality and process improvement plans and determine root cause analysis!

Responsibilities

  • Manage process and product non-conformances in line with company procedures

  • Review, investigate, resolve and report on quality discrepancies

  • Driving quality related improvement projects through cross functional teamwork

  • Supporting and continuously participating as quality representative in problem Solving Projects (PSP) & Kaizen events

  • Support Internal audits, External Audits (BSI, MDSAP, FDA, etc) & Corporate Audits

Qualifications

  • Bachelor’s Degree in Engineering or Sciences or equivalent

  • 3+ years of experience in an FDA regulated and ISO 13485 certified industry

  • Skills in statistical data analysis and statistical techniques

  • Possess knowledge of the Risk Assessment process and Risk Management Files

  • Possess knowledge of verification and validation of products and processes, technical summary reports and user requirement specification

Preferred Qualifications

  • ASQ certification

  • Statistical software knowledge

Compensation

  • The salary range for this role is $76,000 to $105,600. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.

  • This job is also eligible for bonus/incentive pay.

  • We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

  • Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

#LI-SM1

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Given the essential job duties of this position, the employee is required to be fully vaccinated against COVID-19 as a condition of employment, subject to reasonable accommodation and applicable law.

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