Quality Assurance Engineer - Product Development in Sacramento, California at Beckman Coulter Diagnostics

Date Posted: 2/8/2018

Job Snapshot

Job Description

Job ID: BEC008376

About Us

Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.



Beckman Coulter is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.



Description

As a member of the QRA team, the candidate will be responsible to:


  • Provide design control and risk management oversight to multiple development projects.

  • Ensure compliance with applicable regulatory agency requirements, published standards, company policies/procedures, local procedures/work instructions, and project specific plans;

  • Provide guidance to project teams on project specific processes and deliverables. Ensure key elements of product developments are documented in design and development plan or design change plan. Ensure Plans are established and updated timely;

  • Facilitate risk assessments for new designs and design changes at various project development phases. Ensure that risk management activities are performed in accordance with company procedure;

  • Generate and analyze customer feedback data to improve product reliability and performance for our customers that is within the scope of the project;

  • Support development of concise and complete verification and validation strategies that efficiently generate bodies of objective evidence to confirm product requirements compliance and the global regulatory submission strategy. Ensure all test anomalies/deviations are investigated, cause determined, impact assessed, plan of action defined, and resolution is verified;

  • Ensure the product Design History File (DHF) is auditable, traceable, concisely organized, complete, and supports regulatory product registration needs;

  • Drive continuous improvement of new product development procedures, methods, tools, techniques, and training, etc. to support project specific efficiencies.

  • Independently plan, coordinate, and report on product quality programs, which provide a basis for sound technical decisions using techniques in experiment design and data analysis. 

  • Focus on improvement of company performance by defining, designing & implementing strategic improvement projects aligned with business strategies.

  • Develop, maintain, monitor & implement Quality Management systems, protocols & standards. 

Job Requirements



Qualifications

Bachelor’s degree with +5 years experience, Master’s degree with 3+ years of experience, or Doctoral degree with  0-2 years of experience, preferably in areas of knowledge in
microbiological, biological or chemical  assays with experience in a
microbiology/clinical laboratory.


Strong technical background in areas of medical device regulations and processes;


  •      Strong skills in problem solving and in-depth data analysis on products and processes


  • Ability to perform detail-oriented work with a high degree of accuracy

  • Working knowledge of US and International regulations and standards (QSR, ISO, CE-IVD, GLP, cGMP, CLIA, Japan GMP, CMDR)

  • Experience in Verification and Validation & Product Submission/Registration Processes

  • Experience in transferring new products from design to production;

  • Effective communication skills to ensure positive outcomes across a multi-disciplinary team;

  • Experience in Multi-functional project leadership with effective team building, influencing and facilitation skills;

  • Strong technical writing skills


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. A globally diverse team of 81,000 associates, we are united by our culture and operating system, the Danaher Business System, which is our competitive advantage.