Manage Gentuity's complaint handling process ensuring compliance with regulatory standards and Gentuity's QMS.
Analyze and categorize complaints to develop metrics and identify trends and areas for improvement.
Collaborate with cross-functional teams to promptly investigate and resolve complaints.
Prepare and submit detailed reports on complaint investigations to Gentuity's internal and external customers.
Train team members in complaint management best practices.
Maintain accurate documentation of all complaint-related activities in Gentuity's eQMS system.
Supporting members of CAPA team aiding in investigation and root cause analysis.
Provide support for test method development used to determine robust complaint and CAPA root cause.
Support any Post Market Surveillance activities as required to maintain compliance per regulatory requirements.
Other duties as assigned
EXPERIENCE / SKILL REQUIREMENTS :
Time management skills
Microsoft Word, PowerPoint, Excel experience
Organization skills
1 – 3 years, experience in a medical device or pharmaceutical environment.
Investigation experience related to product performance.
Previous experience with eQMS systems preferred.
EDUCATIONAL REQUIREMENTS :
Bachelor's Degree, in a Technical or Scientific / Engineering discipline preferred, OR an equivalent combination of Education and Work Experience.
Equivalence work experience, a minimum of 5 years work experience in medical device or pharmaceutical industry.
serp_jobs.job_alerts.create_a_job
Quality Engineer • Sudbury, MA, US
Job_description.internal_linking.related_jobs
Quality Engineer III
Werfen • Bedford, MA, United States
serp_jobs.job_card.full_time
Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States.Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
We are a worldwide leader in specia...serp_jobs.internal_linking.show_more
Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States.Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
We are a worldwide leader in specia...serp_jobs.internal_linking.show_more
The Leonardo DRS Naval Power Systems business is a trusted provider of innovative naval gas and hybrid power systems, control technology and support solutions for the U.
Navy and navies around the w...serp_jobs.internal_linking.show_more
VirtualVocations • Dorchester, Massachusetts, United States
serp_jobs.job_card.full_time
A company is looking for a Quality Engineer III.Key Responsibilities Develop and execute software quality methods and processes Lead projects and mentor less experienced team members in quality ...serp_jobs.internal_linking.show_more
Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States.Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
We are a worldwide leader in specia...serp_jobs.internal_linking.show_more
Quality Engineer III (Contract) (Location : Nashua, NH area) Preferred Qualifications : Quality Engineer with 5-7+ years’ experience who has a good understanding of GD&T requirements.Qualifications •...serp_jobs.internal_linking.show_more
As a global manufacturer of complex aircraft engine components, Pursuit Aerospace is founded on a commitment to relentless, continuous, operational improvement and extraordinary customer service.We...serp_jobs.internal_linking.show_more
Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States.Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
We are a worldwide leader in specia...serp_jobs.internal_linking.show_more
Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA.The 2,000+ employees of Draper tackle important national challenges with a promise of delivering ...serp_jobs.internal_linking.show_more
VirtualVocations • Worcester, Massachusetts, United States
serp_jobs.job_card.full_time
A company is looking for a Mid-Level Quality Engineer to enhance internal applications and ensure system performance.Key Responsibilities Troubleshoot and resolve issues through root cause analys...serp_jobs.internal_linking.show_more
1010 Analog Devices Inc. • Wilmington, MA, United States
serp_jobs.job_card.full_time +1
NASDAQ : ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge.
ADI combines analog, digital, and software technologie...serp_jobs.internal_linking.show_more
Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA.The 2,000+ employees of Draper tackle important national challenges with a promise of delivering ...serp_jobs.internal_linking.show_more
VirtualVocations • Worcester, Massachusetts, United States
serp_jobs.job_card.full_time
A company is looking for a Solutions Engineer (Post Sales) to bridge technical product capabilities and customer success.
Key Responsibilities Partner with customers post-implementation to ensure ...serp_jobs.internal_linking.show_more
LAB Medical Manufacturing, Inc.ISO 13485 registered manufacturer of medical devices has opening for : Quality Engineer Summary of Position : Lab Medical Manufacturing Inc.
The candidate will support n...serp_jobs.internal_linking.show_more
Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States.Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
We are a worldwide leader in specia...serp_jobs.internal_linking.show_more
VirtualVocations • Lowell, Massachusetts, United States
serp_jobs.job_card.full_time
A company is looking for an Engineer IV focused on Quality Assurance.Key Responsibilities Design, develop, implement, and maintain comprehensive test plans, test cases, and automated test suites ...serp_jobs.internal_linking.show_more
SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positively impact people’s lives in homes around the world....serp_jobs.internal_linking.show_more
Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA.The 2,000+ employees of Draper tackle important national challenges with a promise of delivering ...serp_jobs.internal_linking.show_more
Careers Integrated Resources Inc • Marlborough, MA, US
serp_jobs.job_card.full_time
Job Title : Supplier Quality Engineer.Duration : 11 Months+ (Possibilities of Extension).Shift & Timing : Regular Business Hour, Monday to Friday.
This position provides support to the Global Supplier ...serp_jobs.internal_linking.show_more
Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA.The 2,000+ employees of Draper tackle important national challenges with a promise of delivering ...serp_jobs.internal_linking.show_more