Complaint Handling Coordinator-SCI002762
SCIEX – An operating company within Danaher’s Life Sciences platform
SCIEX helps to improve the world we live in by enabling scientists and laboratory analysts to find answers to the complex analytical challenges they face. Our leadership in LC-MS and CE-MS have made us a trusted partner globally to those who are focused on basic research, drug discovery, food and environmental testing, forensic toxicology, clinical research and diagnostics. With over 40 years of innovation, we continue to redefine what is achievable in routine and complex analysis.
We are seeking smart, team-oriented people who have purpose and are committed to helping us deliver Answers for Science. Knowledge for Life. ™ Our global team, located on every continent, is our greatest strength, bringing diverse perspectives and breakthrough thinking. With the power of the Danaher Business System behind us, it’s our people who have made us the industry leader. Come join our winning team. Visit us at www.sciex.com.
Sciex offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives.
Sciex 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.
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- Review, triage and confirm complaints as per defined criteria
- Enter complaints as needed and per defined criteria
- Perform assignable cause investigations to identify potential failure modes and failure mechanisms
- Assign complaints to the appropriate subject matter experts for filed complaints that may require further investigation
- Determine applicability of the complaints for Medical Device Reporting and Vigilance reporting requirements and work with RA to file MDRs with the appropriate regulated agencies
- Assist with further investigation on complaints that are escalated to CAPAs
- Collaborate with subject matter experts as needed
- Close complaints ensuring that all necessary information has been appropriately documented
- Participate in analysis of complaint trend reports
- Advise and respond to queries on complaints handling
- Apply critical thinking to trouble shooting efforts that support department objectives
- Participate in process improvements
- Maintain in-process and completed records in accordance with established company procedures
- Monitor metrics on the efficacy and efficiency of the complaints handling process and provide regular metric reports to team and to management
- Participate in internal and external audits
- Ensure compliance of operations within area of concern with all relevant EHS regulatory requirement and SCIEX safety policies, procedures and guidelines
- Other duties/ ad hoc tasks as assigned.
- 3 to 5 years of relevant experience
- GMP experience; biotechnology or pharmaceuticals. Medical devices preferred
- Experience in Complaint Investigation or Post Market Surveillance/QA preferred
- Mass Spectrometry experience is an asset (hardware and/or software)
- Medical Technology/clinical laboratory background is an asset
- Excellent writing and organizational skills
- Good computer skills to include email Microsoft applications such as Word and Excel.
- Work may be independent/flexible, so an ability to manage time and productivity to meet department metrics and a high level of personal integrity is required
- Basic knowledge of statistics desired
- Excellent verbal and interpersonal skills
- Strong problem solving skills
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, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 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.
Job Function: Quality and Regulatory Affairs
Primary Location: North America-North America-Canada-ON-Concord