Family Leave
Current
Self-Employed
Paused career to provide compassionate care for a critically ill family member.
Feb 2017 - Present
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Kim Roach Email & Phone Number
Dedicated, self-motivated, and driven professional with over 19 years of medical device experience. Strategic Planning & Execution • Quality Assurance • Regulatory Compliance • Customer Complaint Investigation
at
Self-employed
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Current company
Self-employed
Role
Dedicated, self-motivated, and driven professional with over 19 years of medical device experience. Strategic Planning & Execution • Quality Assurance • Regulatory Compliance • Customer Complaint Investigation
Location
Haltom City, Texas, United States
Who is Kim Roach? Overview
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Kim Roach is listed as Dedicated, self-motivated, and driven professional with over 19 years of medical device experience. Strategic Planning & Execution • Quality Assurance • Regulatory Compliance • Customer Complaint Investigation at Self-employed, based in Haltom City, Texas, United States. AeroLeads shows a matched LinkedIn profile for Kim Roach.
Kim Roach previously worked as Family Leave at Self-Employed and Medical Device Complaint Handling Specialist at Mentor Worldwide, Llc, A Johnson & Johnson Company. Kim Roach holds Computer Science from Texas Tech University.
Profile bio
About Kim Roach
With over 19 years of dedicated experience in the medical device industry, I am a self-motivated and driven professional known for my ability to navigate complex standards, rules, and regulations with ease. Throughout my career, I have consistently demonstrated my capacity to excel in diverse roles and collaborate effectively across all levels of an organization.In my most recent role as a Quality Complaint Handling Specialist at Mentor Worldwide, LLC, a Johnson & Johnson Co., I led the investigation, resolution, and reporting of customer complaints, ensuring timely and accurate analysis. My expertise in regulatory compliance allowed me to oversee documentation and resolution processes in alignment with ISO standards, FDA regulations, and international requirements, including MDD/MDR, ANVISA, and APAC standards.I have a proven track record in auditing, having assisted in quality management system reviews and FDA audits, while also coordinating with external auditors during official assessments. Additionally, my technical proficiency extends to facilitating complaint handling processes through database management and electronic reporting systems, showcasing my adaptability to emerging technologies and methodologies.Throughout my tenure, I have fostered cross-functional collaboration by facilitating multi-department meetings and cross-training initiatives, resulting in streamlined processes and enhanced communication across teams. My strategic approach to problem resolution and commitment to quality assurance have consistently driven success in achieving organizational objectives.As I continue to pursue opportunities in the medical device industry, I am eager to leverage my extensive experience and skills in strategic planning, project management, and regulatory compliance to contribute to a dynamic team and drive meaningful impact in healthcare innovation. Let's connect to explore potential collaborations and opportunities for mutual growth.
Current workplace
Kim Roach's current company
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Self-Employed
4 roles
Kim Roach work experience
A career timeline built from the work history available for this profile.
Medical Device Complaint Handling Specialist
- Supervised the investigation, resolution, and reporting of all adverse events (AE). Processed, investigated, and monitored trending and reporting of product defect complaints. Investigated and resolved complex issues..
- Prioritized information from technical perspective to ensure complaint analysis and investigations were processed in timely manner.
- Conducted complaint investigations using device evaluation results including visual standards, root cause analysis, and corrective action decisions.
- Reviewed complaint files for accuracy and entered investigation results into database, including observation codes, failure codes, investigation assessment, and summary.Regulatory Compliance
- Conducted regulatory reviews of customer complaints; assessed and recorded regulatory reporting.
- Oversaw the documentation and resolution of customer reports and complaints in accordance with company policies and procedures to ensure compliance with regulatory agency reporting requirements.
Aug 2004 - Feb 2017
Product Evaluation Intake Coordinator
- Conducted phone interviews with physicians, medical staff, sales representatives, and affiliates related to regulatory reporting to obtain Class III medical device complaint information. Generated new complaints in.
- Created hard files containing complaint history and patient information, and updated database.
- Coordinated no-charge replacement devices and return kits.
- Conducted database queries to support complaint and patient failure trend analysis.
- Notified management of potential manufacturing or design-related complaints, such as labeling, for investigation and possible escalation.
- Coordinated no-charge replacements according to Mentor Lifetime Replacement Policy with international customer service.
Sep 2000 - Aug 2004
Product Evaluation Lab Technician
Mentor Corporation
- Used basic inspection test equipment and determined appropriate tool for measurement to be performed including micrometers, calipers, dial thickness gauges, or microscope.
- Read and interpreted drawings, QCICs, and test methods.
- Conducted and summarized laboratory evaluations on medical devices through gross evaluation, leak testing, and microscopic examination.
- Documented, photographed, assigned lab numbers, and conducted data entry on returned medical devices.
Jul 1998 - Sep 2000
2 education records
Kim Roach education
Computer Science
Business Administration
FAQ
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What company does Kim Roach work for?
Kim Roach works for Self-employed.
What is Kim Roach's role at Self-employed?
Kim Roach is listed as Dedicated, self-motivated, and driven professional with over 19 years of medical device experience. Strategic Planning & Execution • Quality Assurance • Regulatory Compliance • Customer Complaint Investigation at Self-employed.
Where is Kim Roach based?
Kim Roach is based in Haltom City, Texas, United States while working with Self-employed.
What companies has Kim Roach worked for?
Kim Roach has worked for Self-Employed, Mentor Worldwide, Llc, A Johnson & Johnson Company, and Mentor Corporation.
How can I contact Kim Roach?
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What schools did Kim Roach attend?
Kim Roach holds Computer Science from Texas Tech University.
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