Easter Seals Jobs

Job Title: Quality Assurance Coordinator

Location: Haslet, TX

Company Overview:

A leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. The company is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

Hours: This is an on-site position, five days a week, from Monday to Friday. Flexibility to work additional hours or weekends may be required based on business needs.

Pay: Will based on the experience

Summary:

The Quality Assurance Coordinator is integral to maintaining and supporting quality assurance processes within the medical device distribution center. This role ensures compliance with Good Manufacturing and Distribution Practices, ISO 13485 standards, and company quality and regulatory requirements. The coordinator is responsible for executing tasks assigned by the Quality Assurance Supervisor to uphold the effectiveness of the Quality Management System. Additionally, they act as a key collaborator in preserving quality compliance and driving continuous quality system improvement initiatives across the Distribution Center.

This role requires close collaboration with cross-functional teams to address quality concerns and ensure proper evaluation and handling to maintain quality standards in compliance with Good Distribution and Manufacturing Practices. The Quality Assurance Coordinator serves as a key point of contact for quality-related activities, contributing to consistent compliance to guarantee that the quality, integrity, and safety of the products are maintained throughout the distribution center’s operations.

Essential Functions & Accountabilities:

• Performs assigned daily tasks effectively, on time, and in compliance with Good Distribution Practices.

• Performs the incoming quality inspection process to verify that received materials meet quality standards.

• Maintain the Quality Order process, ensuring accurate records, documentation, and timely release.

• Conduct the Return Material Authorization (RMA) process, ensuring returned materials are inspected, received, and appropriately dispositioned.

• Collaborate with cross-functional teams to address quality concerns and drive continuous improvement.

• Support the maintenance of the Quality Management System in compliance with ISO 13485 standards and regulatory requirements.

• Conduct assigned non-routine inspections on finished goods, comparing results with company quality standards, and communicating and addressing any findings as necessary.

• Perform product inspections at various stages of the distribution process, including visual inspection as well as cycle counts.

• Generate Non-Conformance Material Reports (NCMRs) when inspection results indicate deviations or when significant quality issues are identified.

• Act as a resource for other departments on quality-related issues. Participate in cross-functional meetings to facilitate information exchange, troubleshoot issues, and provide quality assurance recommendations.

• Maintain proper documentation control, including updates to procedures, work instructions, and records.

• Identify areas for process improvements and support the implementation of changes to enhance the effectiveness of the quality system and ensure product quality.

• Support the monitoring of the Temperature Monitoring System within the distribution center's temperature-controlled areas.

• Perform other duties or assignments as required by the Quality Assurance management team.

• Foster a culture of quality and continuous improvement within the distribution center.

Education and Experience:

• Must possess a high school diploma or GED.

• Minimum of 3 years of experience in Quality Assurance or a related field within the medical devices distribution, pharmaceuticals, or life sciences industry.

• Certifications in Quality System, ISO 13485 are preferred.

• Experience with cold chain management and temperature monitoring systems is a plus.

• Proficiency in Microsoft Office Suite, D365 ERP, and other relevant applications are preferred.

• Experience in healthcare, medical devices, or other regulated industries operating under FDA regulations is highly preferred.

• Good communication skills, results-driven, innovative, creative, and action-oriented.

• Critical thinking and decision-making skills, with the ability to multitask in a fast-paced environment.

• Ability to review and comprehend written instructions, including specifications and quality inspection methods and requirements.

Travel: Not applicable.

Our Benefits:

As an employee, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick, and holidays, and multiple other perks and benefits.

Pay Details: $50,000.00 to $60,000.00 per year

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act

• Los Angeles City Fair Chance Ordinance

• Los Angeles County Fair Chance Ordinance for Employers

• San Francisco Fair Chance Ordinance