Quality Assurance Specialist
Danaher Corporation
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Cytiva, one of Danaher’s (https://danaher.com/our-businesses) 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career.
Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.
The Quality Assurance Specialist is responsible for leading a Complaint Handling Unit (CHU) supporting and executing the triage, investigation, and closure of product quality complaints. Additional key responsibility are metrics, follow-up, and analysis for items in the CAPA and nonconformity system, whether or not complaint related.
This position reports to the Senior QA Manager and is part of the Quality Assurance team located in Burnaby, BC and will be an on-site role.
What you will do:
+ Lead a Complaint Handling Unit (CHU) supporting and executing the triage, investigation, and closure of product quality complaints. Tasks include coordinating and supporting investigations, running trend reports, performing statistical analysis of trends, tracking major issues and related corrective actions, assisting in final customer reports, and interfacing with customers in various forms of communications.
+ Facilitate risk-assessment activities and acts as QA lead for Field Actions involving Aseptic Filling product groups
+ Support internal and external audits as Subject Matter Expert from a complaint handling unit perspective
+ Provide metrics and oversight of the deviation, CAPA, and complaint systems, including high-level analysis for management review
Who you are:
+ Bachelor's degree in Biological Sciences, engineering, or related field (e.g., Biomedical Engineering, Systems Engineering, Pharmacology, Chemistry) or equivalent work experience
+ Multiple years relevant experience dealing with post market surveillance activities (complaint triage, investigations, CAPA, etc.)
+ Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English
+ Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
+ Experience with root cause analysis, nonconformance investigation, and CAPA management
It would be a plus if you also possess previous experience in:
+ Experience in a regulated environment such as medical devices (ISO 13485), pharmaceuticals (GMP), or biotechnology.
+ Proficiency with quality management systems (QMS) and tools like Veeva, TrackWise, Salesforce, Magic.
Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home) .
The salary range for this role is $79,500-$90,000 CAD. 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. 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 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.
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Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com .
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.
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