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Qa Stability Program Coordinator Jobs (NOW HIRING)

... Stability. * Adheres to internal standards, policies, and procedures * Performs other ... Proficiency in Microsoft Office programs (Excel, Outlook, Word) (Required) * Ability to lift/carry ...

Quality Assurance Specialist

Boulder, CO · On-site

$105K - $125K/yr

Provide Quality Assurance support for the OnKure stability programs, including review and approval of stability protocols and reports. * Provide Quality Assurance support in the drafting and periodic ...

The Quality Assurance Coordinator will assist with the administration and document control of the ... Stability. * Adheres to internal standards, policies, and procedures * Performs other ...

Responsibilities Summary As a Quality Assurance Coordinator servicing various industry clients, you ... By evaluating performance against program requirements and compliance standards, this position ...

Position Overview The Quality Assurance (QA) Coordinator is responsible for developing, implementing, and continuously improving quality processes, procedures, and controls to support operational ...

Summary As a Quality Assurance Coordinator servicing various industry clients, you will ensure best ... By evaluating performance against program requirements and compliance standards, this position ...

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Qa Stability Program Coordinator information

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How much do qa stability program coordinator jobs pay per hour?

As of Jun 9, 2026, the average hourly pay for qa stability program coordinator in the United States is $26.56, according to ZipRecruiter salary data. Most workers in this role earn between $20.91 and $30.53 per hour, depending on experience, location, and employer.

What is the difference between Qa Stability Program Coordinator vs Quality Assurance Specialist?

AspectQa Stability Program CoordinatorQuality Assurance Specialist
CertificationsGMP, ISO, or industry-specific quality certificationsGMP, ISO, or industry-specific quality certifications
Work EnvironmentManufacturing, pharmaceutical, or biotech settings focusing on product stabilityManufacturing, pharmaceutical, or biotech settings focusing on product quality
Employer & Industry UsageUsed in industries requiring product stability testing and validationUsed across industries for ensuring product quality and compliance

The Qa Stability Program Coordinator primarily focuses on managing and overseeing product stability programs, ensuring products meet regulatory standards over time. In contrast, the Quality Assurance Specialist has a broader role in maintaining overall product quality and compliance. Both roles require similar certifications and work in comparable environments, but their core responsibilities differ slightly, with the coordinator emphasizing stability testing and the specialist focusing on quality assurance processes.

What cities are hiring for Qa Stability Program Coordinator jobs? Cities with the most Qa Stability Program Coordinator job openings:
What states have the most Qa Stability Program Coordinator jobs? States with the most job openings for Qa Stability Program Coordinator jobs include:
Infographic showing various Qa Stability Program Coordinator job openings in the United States as of May 2026, with employment types broken down into 86% Full Time, and 14% Part Time. Highlights an 100% In-person job distribution, with an average salary of $55,255 per year, or $26.6 per hour.
Director, Quality Assurance

Director, Quality Assurance

Femasys, Inc.

Suwanee, GA

Full-time

Posted 28 days ago


Job description

Position Summary
The Director of Quality Assurance is responsible for leading the application of quality assurance principles and techniques in the planning, development, and implementation of quality systems processes and procedures to support the various functions of the organization, specifically R amp;D, Clinical and manufacturing.
Core Responsibilities
  • Management Representative with the authority and responsibility for ensuring the quality system requirements are effectively established, implemented and maintained; reporting on the performance of the quality system, and any need for improvement, to executive management; and ensuring the promotion of awareness of regulatory and customer requirements throughout the organization.
  • Oversee day to day operations and provide strategic/operational direction for the Company’s Quality Assurance department including management and development of QA personnel, final product testing and release, receiving and in-process testing, stability testing, QC inspections and audits, and QC documentation.
  • Jointly responsible with the Vice President, Regulatory amp; Clinical Affairs to serve as PRRC (person responsible for regulatory compliance) as defined in the European Medical Device Regulation 2017/745.
  • Develop and implement effective internal quality policies, procedures, and training programs consistent with Company objectives, customer needs, and FDA QSR/ cGMPs, ISO 13485 regulations, and CE marking guidelines.
  • Analyze, develop, implement, and audit policies and procedures for applicability and compliance to regulations.
  • Responsible for company-wide quality system procedures for executing how the company handles process validation, process control and enhancements, quality metric reporting, supplier qualification, design assurance programs, complaint handling and CAPA programs.
  • Manage material control program to include: QC materials management including labeling and storage, QC materials inventory and use and materials lot control.
  • Support engineering in the development, testing, verification, validation, and commercialization of new products, or changes to existing products to assure products conform to government and Company standards and satisfies all applicable regulations.
  • Support engineering in the qualification and validation of equipment and processes.
  • Develop, coordinate, and administer internal and third-party quality audits, inclusive of schedules, communication, reports, and tracking follow-up actions.
  • Interface with the FDA, ISO, CE, and other international regulatory agents or surveillance auditors. Respond to regulatory and/or third-party audit observations.
  • Develop and implement instructions/methods for inspecting, testing, and evaluating product conformance to specification.
  • Process non-conforming material reports including MRB dispositioning. Work with suppliers to correct problems.
  • Maintain the corrective/preventive action program, inclusive of tracking status of open actions, receiving and reviewing responses, working with departments for timely completion, and periodic reports and metrics.
  • Support manufacturing in the investigation of manufacturing problems and product complaints to determine the root cause and recommend appropriate corrective and preventive action to avoid recurrence. Lead and perform component/product testing.
  • Responsible for the deployment, validation, and maintenance of the Quality Management System software.
  • Maintain the product stability program, including both real time and accelerated aging.
  • Evaluate quality data, prepare periodic reports to monitor trends, and report to management to ensure the Company’s continuous improvement efforts are on track.
  • Review and approve reports and other documentation prepared by QA and QC for regulatory submissions/inspections.
  • Act as primary quality team member for projects and product teams, providing counsel, training, and interpretation of FDA and other applicable regulations to Company personnel.
  • Participate in risk analysis to identify appropriate protective measures to mitigate risk associated with identified hazards.
Qualifications
Required:
  • Bachelor’s degree in Engineering, Science or related field degree
  • 8+ years experience in Quality Assurance, Quality Engineering, or related functions in a medical device or FDA regulated company
  • Good working knowledge of FDA Quality System Regulation 21 CFR Part 820 (cGMP/QSR) and related parts, 21 CFR Part 58 (GLPs), ISO 13485, 93/42/EEC (EU Medical Device Directive) and MEDDEV 2.12 (Medical Device Vigilance Guideline)
  • Good organizational and follow-through skills with exceptional attention to detail
  • Excellent verbal and written communication skills
  • Demonstrated presentation, facilitation skills and the ability to interact and communicate with senior management and technical staff at all levels
  • Understanding of statistics required – Cp, Cpk, AQL, etc.
Preferred:
  • Startup or early-stage medical device experience.
  • ASQ, CQM (Certified Quality Manager) or CQE (Certified Quality Engineer) are highly desirable.
  • Class III Medical Device experience