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Senior Quality Assurance Engineer

Company: Danaher
Location: Loveland
Posted on: May 3, 2021

Job Description:

Wondering what's within Beckman Coulter?

Take a closer look.

Join a team where you can be heard, be supported, and always be yourself. At Beckman Coulter, a Danaher company, we're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. We are dedicated to advancing and optimizing the laboratory to move science and health care forward for more than 80 years. Find the opportunity to build relevant career, be creative, and try new things with the support needed to be successful. Find the Danaher Business System, which makes everything possible.

What you find at Beckman Coulter -and within yourself - might just change the world!

The Senior Quality Assurance Engineer for Beckman Coulter Life Sciences reports to the Senior Manager of Quality Assurance Engineering in Loveland, CO.

This role provides guidance and direction to cross functional design change teams to meet design control requirements in support of post launch design changes. It also supports Quality Management System activities for the Colorado Design Center.

If you thrive in a fast-paced, high-impact role and want to work to build a world-class QA organization - read on.

In this role, you will have the opportunity to:

  • Ensure conformity of the design change process with applicable regulations and company procedures. Review and approve documentation related to the projects supported. Responsible for Design History File (DHF) completeness and maintenance.
  • Represent all QA functions involved with the project within the change team structure. Support and engage with extended QA team on a regular basis to ensure on time delivery of activities.
  • Contribute to risk management activities: Identify sources of risk such as ergonomics, use error and risks associated with product characteristics.
  • Support audit and inspection preparation, resolution of audit and inspection findings.
  • Support investigation and corrective action activities resulting from customer complaints, quality discrepancies, and non-conformances and coordinate resolutions with appropriate functions.
  • Review marketing and promotional materials for accuracy of claims.
  • Interact frequently with other functional areas and operating entities often communicating difficult concepts and applying problem solving techniques which requires specialized depth and/or breadth of expertise.

The essential requirements of the job include:

  • Bachelor's degree in engineering or science discipline with 5+ years of experience in a regulated environment, Master's degree in engineering or science discipline with three years of experience in a regulated environment, or Doctoral degree in engineering or science discipline with 0-2 years of experience in a regulated environment.
  • Experience in application of design controls in accordance with 21 CFR Part 820, ISO 13485, and ISO 9001 for the development of products and design changes.
  • Produce detailed and comprehensive quality system documentation and reports.
  • Ability to travel up to 10% when business travel is allowed.

This experience is a plus:

  • Certified Quality Auditor to ISO 9001:2015 is a plus.

The salary range for this role is $85,000 - 105,000.00 annually.

  • This job is also eligible for 10% incentive compensation pay.
  • The Company also offers benefits as outlined danaherbenefitsinfo.com to eligible employees.
  • The hourly or salary range is the range Beckman Coulter Life Sciences in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate's experience, qualifications, seniority, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range is only applicable for jobs to be performed in Colorado. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. 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.

Beckman Coulter, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to associates' lives. Whether it's a health care program or paid time off, our programs offer value to life beyond the job.

At Beckman Coulter, we're driven by a sense of wonder for what we can create-and what we can become. Accelerate your career while driving innovation that improves lives. Work hard and try new things, with guidance from committed leaders, powerful DBS tools, and the support of a global organization. As part of the Danaher's 67,000 associates across the globe, the possibilities for growth and development are unparalleled.

We believe that creativity and innovation thrive when the most diverse set of voices are heard, and that's why we're taking concrete steps to ensure that we're fostering an inclusive and engaging workplace. Read about our associates on our Careers Blog or contact one of our recruiters.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified 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. The "EEO is the Law" poster is available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified 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. The "EEO is the Law" poster is available here.

Keywords: Danaher, Loveland , Senior Quality Assurance Engineer, Other , Loveland, Colorado

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