Insmed
QA Product Quality Complaint Specialist
Insmed, Bound Brook, New Jersey, United States, 08805
Product Quality Complaint Associate, QA
Reporting to the Director, Product Quality Complaints, the Product Quality Complaint Associate, QA will play a key role in the complaint process. Specific areas of responsibility include: Ensure accurate and thorough complaint intake information, replacement need, trouble-shooting with complainant, patient follow-ups, product complaint investigations, tracking and trending of complaint data. The position is based in our Bridgewater, NJ HQ (onsite 3 days a week). Responsibilities
Additional representative responsibilities will include, but not necessarily be limited to, the following: Accurately enter commercial, clinical and/or compassionate use complaints into the internal software system/QMS. Review each complaint assigned for accurate/missing information, complaint details, further regulatory compliance actions, replacement needs, or unreported adverse events. Act as a technical product subject matter expert and trouble shoot complaints with complainants. Contact complainants for follow up information, trouble shooting and device returns. Perform complaint investigations to determine root cause, identify resolution and respond to the complainants. Ensure adverse events reported through the complaint system or at patient follow-up are reported within 24 hours. Provide product training and complaint training to internal and external stakeholders. Partner with colleagues in other departments to increase the overall effectiveness of the Quality Assurance department. Manage workload and call volume within pre-defined KPIs and SLAs. Recognizes and identifies opportunities for improvement around product complaints and device support processes; shares best practices with the Patient Support & Quality teams. Investigations associated to complaint trending along with associated CAPA. Qualifications
BS or associate degree in engineering, Life Science or related discipline preferred, and a minimum of 1-2 years of relevant Quality Assurance experience. Experience with a patient calls/complaint intake in a regulated industry. Must be thoroughly knowledgeable on relevant cGMP's and Good Documentation Practices Must have excellent communication skills (verbal and written). Demonstrate ability to manage projects and variable workloads. Highly organized with a strong attention to detail, clarity, accuracy and conciseness. Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook). Must successfully exhibit Insmed's five (5) values: Collaboration, Accountability, Passion, Respect, Integrity. Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace. Salary Range
$73,000 - $97,200 a year Compensation & Benefits
At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location: Flexible approach to how we work Health benefits and time-off plans Competitive compensation package, including bonus Equity Awards (Long-Term Incentives) Employee Stock Purchase Plan (ESPP) For more information on U.S. benefits click here. Additional Information
Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Applications are accepted for 5 calendar days from the date posted or until the position is filled.
Reporting to the Director, Product Quality Complaints, the Product Quality Complaint Associate, QA will play a key role in the complaint process. Specific areas of responsibility include: Ensure accurate and thorough complaint intake information, replacement need, trouble-shooting with complainant, patient follow-ups, product complaint investigations, tracking and trending of complaint data. The position is based in our Bridgewater, NJ HQ (onsite 3 days a week). Responsibilities
Additional representative responsibilities will include, but not necessarily be limited to, the following: Accurately enter commercial, clinical and/or compassionate use complaints into the internal software system/QMS. Review each complaint assigned for accurate/missing information, complaint details, further regulatory compliance actions, replacement needs, or unreported adverse events. Act as a technical product subject matter expert and trouble shoot complaints with complainants. Contact complainants for follow up information, trouble shooting and device returns. Perform complaint investigations to determine root cause, identify resolution and respond to the complainants. Ensure adverse events reported through the complaint system or at patient follow-up are reported within 24 hours. Provide product training and complaint training to internal and external stakeholders. Partner with colleagues in other departments to increase the overall effectiveness of the Quality Assurance department. Manage workload and call volume within pre-defined KPIs and SLAs. Recognizes and identifies opportunities for improvement around product complaints and device support processes; shares best practices with the Patient Support & Quality teams. Investigations associated to complaint trending along with associated CAPA. Qualifications
BS or associate degree in engineering, Life Science or related discipline preferred, and a minimum of 1-2 years of relevant Quality Assurance experience. Experience with a patient calls/complaint intake in a regulated industry. Must be thoroughly knowledgeable on relevant cGMP's and Good Documentation Practices Must have excellent communication skills (verbal and written). Demonstrate ability to manage projects and variable workloads. Highly organized with a strong attention to detail, clarity, accuracy and conciseness. Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook). Must successfully exhibit Insmed's five (5) values: Collaboration, Accountability, Passion, Respect, Integrity. Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace. Salary Range
$73,000 - $97,200 a year Compensation & Benefits
At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location: Flexible approach to how we work Health benefits and time-off plans Competitive compensation package, including bonus Equity Awards (Long-Term Incentives) Employee Stock Purchase Plan (ESPP) For more information on U.S. benefits click here. Additional Information
Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Applications are accepted for 5 calendar days from the date posted or until the position is filled.