Experienced Quality Engineer - Carlsbad in Carlsbad, California at Radiometer

Date Posted: 11/11/2019

Job Snapshot

Job Description

Job ID: AME000201

About Us

At Radiometer, our mission is to help caregivers make diagnostic decisions that save lives. To provide caregivers the insight and confidence that help them arrive at the right diagnostic decisions – decisions that in the end help save lives.
On a yearly basis millions of lives are touched by the information our solutions provide and that’s a fact, we take very seriously; the more critical the setting, the greater the requirements are and that’s why we’ve made it our vision to improve global healthcare with reliable, fast and easy patient diagnoses.
Want to know more about our mission and vision? Click on the link: Link of YouTube video
Our people
At Radiometer, we acknowledge that the information our products provide is often the difference between life and death; an acknowledgement that drives and unites us as a company. From biotech and software specialists to financial controllers and engineers, all 3800 colleagues are committed and dedicated to help realize life’s potential.

If you aspire to be part of a purpose, performance and values driven organization whose mission and vision guide every action, we are eager to hear from you.


Description

The primary responsibility of this position is to identify, monitor and improve quality metrics and processes in support of the quality goals of SenDx Medical, Inc. This position actively participates in team activities to ensure that the manufacturing processes are compliant with company procedures as well as FDA/ISO regulations and standards. The incumbent will serve as a technical resource to product development, manufacturing and suppliers to improve process capability, reliability and the quality of products. Will create quality and process improvement plans and drive root cause analysis activities.

PHYSICAL REQUIREMENTS (As required by the Americans With Disabilities Act)

General physical requirements: Sedentary work, physical requirements– requires lifting 50 lbs.
Visual acuity requirements: Administrative
Motion and sensory requirements: Walking, talking, hearing, light to medium manual dexterity
Physical working conditions: Working environment is inside in administrative area, inside in manufacturing area, inside in laboratory area.  

PRINCIPAL ACCOUNTABILITIES/ESSENTIAL JOB FUNCTIONS 
  • Ensure adherence to Quality System requirements in an FDA and ISO regulated environment throughout product and process lifecycles. This includes products in design and development as well as products in production and the processes which support them.
  • Perform investigations and root-cause analysis activities as they related to Corrective/Preventative Actions (CAPA), and drive continuous improvement.
  • Perform analysis, trending and reporting of inspection and test data to insure conformance to specifications.
  • Perform design and process validation studies in conjunction with R&D, Engineering and Manufacturing to ensure compliance to applicable standards.  Ensure validation and revalidation of production cells by evaluating equipment and processes for critical and non-critical parameters, performing capability studies and integrating findings into validation protocols.
  • Ensure compliance in manufacturing areas and escalate nonconforming situations. Initiate and lead root cause investigations and documentation for non-conformities. Review dispositions of non-conformities for compliance and presence of objective evidence.
  • Perform in-house failure and complaint investigations to determine deficiencies in product design and manufacturing processes.
  • Perform and/or assist with conducting verification of effectiveness checks related to corrective and preventative actions as identified in the SenDx corrective and preventative action program (CAPA).
  • Identify, initiate and lead process and compliance improvement. Implement improvements and methods for measuring effectiveness of changes.
  • Administration of statistical sampling plans for incoming inspection and finished product testing.
  • In conjunction with engineering and manufacturing, assist with the implementation and maintenance of statistical process controls were applicable.
  • Assess and ensure compliance with applicable standards of design control, risk management, adequacy of testing and process and production control systems.
  • Compilation and analysis of information for Quality Management Reviews and external audits.  Perform trending on key Quality System metrics.
  • Utilize Danaher Business System (DBS) concepts and tools in the performance of daily activities.
  • Perform other duties & projects as assigned.
 

Job Requirements



Qualifications

Education: BS or BA in Engineering or Life Sciences
Experience: Minimum of 7 years in the medical products industry
Skill/Aptitude: Familiarity with QSR (FDA) & ISO Standards, Design and Process Validation Experience
Alternate Qualifications: ASQ QE Certification desirable
Required Licenses: None

Reports To: Manager, Quality Assurance
Supervisory Responsibilities: None, may be required to supervise technician or inspector on a project basis.
Key Internal Customers: Daily interface with Research and Development, Engineering, Quality Control, Regulatory Affairs, Manufacturing, Manufacturing Engineering, Technical Service on project and product issues. 
Key External Customers: Occasional interfacing with Radiometer and/or distributors for purposes of resolving product problems.

Diversity & Inclusion
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
 

Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.