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Professional Qms Implementation Jobs in Kentucky

$110 - $170/hr

... implement and grow a value-added QMS grounded in FDA and ISO 13485 requirements. This role has no ... Professional certification (ASQ, RAPS) * ISO 13485 Auditor certification * Experience with Software ...

$110 - $130/hr

... QMS) across the full project portfolio, driving on-time, on-budget, high-quality outcomes at scale ... Ensure consistent, professional communication standards--including structured kickoff, progress ...

Support QMS Development and Maintenance: Assist with maintaining and improving QMS processes ... Change Management Support: Assist in implementing process changes or new quality systems. Help ...

Support QMS Development and Maintenance: Assist with maintaining and improving QMS processes ... Change Management Support: Assist in implementing process changes or new quality systems. Help ...

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Manufacturing Engineering & Quality Professional

Fairdale, KY · On-site

$69K - $89K/yr

Quality System Engineer (QMS) * Laboratory Engineer * EHS Engineer * Material Planner & Customs ... Monitor key performance indicators (KPIs) and implement continuous improvement projects focused on ...

$75 - $110/hr

... and QMS etc.)* Take lead responsibility for significant quality issues and Quality Management ... Administer, develop and implement programs and initiatives to improve quality assurance efforts*

$135 - $160/hr

... implement new certifications as identified by the business. * Quality Management System (QMS ... Languages * English required, French and Spanish preferred but not mandatory Professional ...

Site Manager, MEP

Lexington, KY · On-site

$90 - $130/hr

... professional services, specialty equipment, and real estate. Since 1960, Gray has grown from a ... Will insure the company QMS program is used and maintained in accordance to company standards.

... professional services, specialty equipment, and real estate. Since 1960, Gray has grown from a ... Will insure the company QMS program is used and maintained in accordance to company standards.

$85 - $115/hr

Map operational routing, configure electronic Work Instructions (eWI), implement automated part ... QMS) and Management of Change (MOC) protocols. * Project Management : Lead NPI as liaison between ...

... professional services, specialty equipment, and real estate. Since 1960, Gray has grown from a ... Will insure the company QMS program is used and maintained in accordance to company standards.

$85 - $120/hr

... professional. * You will perform work on technical projects where you will follow Integer ... QMS), supporting corrective and preventive actions investigation and implementation, and ...

... professional services, specialty equipment, and real estate. Since 1960, Gray has grown from a ... Will insure the company QMS program is used and maintained in accordance to company standards.

... professional services, specialty equipment, and real estate. Since 1960, Gray has grown from a ... Will insure the company QMS program is used and maintained in accordance to company standards.

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Professional Qms Implementation information

What is a professional QMS implementation?

A Professional QMS (Quality Management System) Implementation refers to the process of systematically establishing and integrating quality management practices within an organization, typically aligned with recognized standards like ISO 9001. Professionals in this role analyze current processes, identify gaps, develop policies and procedures, train staff, and ensure continuous improvement to meet quality objectives. The goal is to enhance product or service quality, improve customer satisfaction, and ensure regulatory compliance. Successful implementation often involves change management, documentation, and ongoing monitoring to sustain quality outcomes.

What are the key skills and qualifications needed to thrive as a professional QMS implementation specialist?

To excel as a Professional QMS Implementation Specialist, you need a strong understanding of quality management principles, relevant industry standards (such as ISO 9001), and often a bachelor's degree in a related field. Familiarity with QMS software platforms, documentation systems, and certifications like ISO 9001 Lead Auditor are commonly required. Excellent project management, problem-solving, and communication skills set standout professionals apart in this role. These competencies are vital for ensuring effective system rollout, regulatory compliance, and continuous organizational improvement.

What are some common challenges faced during the implementation of a quality management system, and how can professionals address them?

Professionals implementing a QMS often encounter challenges such as resistance to change, lack of employee engagement, and difficulty aligning new processes with existing workflows. To address these, it's crucial to communicate the benefits of the QMS clearly, involve staff at all levels early in the process, and provide ongoing training and support. Collaboration with cross-functional teams and regular feedback sessions can also help smooth the transition and ensure successful adoption of the QMS.

What is the difference between Professional Qms Implementation vs Quality Assurance Specialist?

AspectProfessional Qms ImplementationQuality Assurance Specialist
CertificationsISO 9001 Lead Implementer, Internal AuditorISO 9001 Auditor, QA Certifications
Work EnvironmentImplementing and customizing QMS processes, working with cross-functional teamsMonitoring, testing, and auditing products/processes for quality compliance
Employer & IndustryManufacturing, Healthcare, Automotive, requiring QMS setupManufacturing, Software, Healthcare, focusing on product/service quality

Professional Qms Implementation focuses on establishing and customizing quality management systems within organizations, ensuring compliance and process integration. In contrast, a Quality Assurance Specialist primarily monitors and audits existing processes to maintain quality standards. Both roles require similar certifications but differ in scope and daily responsibilities.

What cities in Kentucky are hiring for Professional Qms Implementation jobs?

Cities in Kentucky with the most Professional Qms Implementation job openings:

Quality Assurance Manager

On-site

UpDoc, Inc.
Health Care and Social Assistance • 1 - 10 employees

$110 - $170/hr

Other

Posted 7 days ago


Job description

About UpDoc

At UpDoc, we are building the first clinically validated, physician-supervised AI agents that manages chronic diseases. We are an early-stage startup founded by Stanford physicians.

We are seeking a talented and motivated QA Manager, reporting to the Director of Quality Assurance to join our team and help us build and scale our quality management system as we bring our AI-powered chronic disease platform to patients and providers.

This is a fully remote position.

Who You Are

You're an enthusiastic, self-motivated quality professional with strong communication skills and a track record of building a culture of quality from the ground up. You're comfortable being hands-on in a fast-paced startup environment, and excited to implement and grow a value-added QMS grounded in FDA and ISO 13485 requirements. This role has no direct reports today, but will grow the function over time as the company scales.

What You'll Do
  • Lead internal audits, gap assessments, and action item closure for periodic QMS reviews
  • Manage and Maintain Design and Development Files for FDA regulated products.
  • Manage Quality Training: Guide team members on quality system use, and follow up on training compliance and QMS action items
  • Build and refine quality systems and SOPs in line with cGxP, ISO 13485, and other applicable standards
  • Own and manage UpDoc’s NCR, CAPA, and post-market surveillance processes
  • Administer, and maintain UpDoc's eQMS (Qualio)
  • Collaborate across departments to follow through on change implementation action items
  • Assist or provide support to the customer support team as needed
What You'll Need
  • Working knowledge of core QMS concepts and medical device standards, including 21 CFR 820, ISO 13485, and ISO 14971
  • Experience implementing or improving quality processes at a medical device or digital health company
  • 7+ years in a regulated medical device environment (software experience preferred), including 5+ years in an FDA-regulated environment
  • Bachelor's degree in Computer Science, Life Sciences, Engineering, or equivalent experience
  • Comfort with common software startup tools and platforms, such as Jira, Linear, Slack and Google Workspace
Highly Desired
  • Professional certification (ASQ, RAPS)
  • ISO 13485 Auditor certification
  • Experience with Software as a Medical Device (IEC 62304, IEC 82304)
  • Experience in early-stage or high-growth startups, building QMS process from scratch
  • Experience with HIPAA and SOC 2 regulated environments
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UpDoc logo

About UpDoc

Sourced by ZipRecruiter

Industry

Health care and social assistance

Company size

1 - 10 Employees

Headquarters location

Palo Alto, CA, US