Quality Engineer I

Description

Job Title : Quality Engineer I

Company Summary :

BioLab Holdings is a regenerative health company focused on providing innovative solutions that encourage the body to heal naturally. Our mission is to raise the standard of caring. Since its founding, BioLab Holdings has experienced explosive growth and is actively developing new technologies to innovate, improve customer experience, and expand its market share within the wound management space. We are seeking individuals who are passionate about making a difference in the work they do and will help support our company's mission.

Reports To : Quality Engineering Supervisor

Job Overview :

We are seeking a detail-oriented and hands-on Quality Engineer I to join our Quality Team. This role will focus on ensuring compliance with regulatory standards and supporting continuous improvement initiatives. You will be instrumental in enhancing our quality systems, improving processes, and supporting new product launches and regulatory submissions. The ideal candidate will ensure compliance with regulatory standards, lead continuous improvement initiatives, and collaborate cross-functionally to maintain the highest quality standards throughout the product lifecycle.

Essential Functions :

Quality System Improvement

• Develop and implement strategies to enhance quality systems, ensuring compliance with GMP, ISO 13485, FDA 21 CFR 820, and EU MDR regulations
• Review and optimize manufacturing processes to improve efficiency, product quality, and regulatory compliance
• Support change management processes, including impact assessments for process, material, or equipment changes

New Product Launch and Regulatory Submissions Support

Process Validation

Nonconformance & CAPA Management

Risk Management and Continuous Improvements

Documentation & Training

Qualifications : Education :

Experience :

Skills & Competencies :

Location : On-Site - Mesa, AZ

What We Offer :

Looking for a company to work at can be a daunting task, but we believe that we stand out from the rest. Our company offers a positive and inclusive work environment, opportunities for growth and development, and a commitment to work-life balance. Join us and become part of a team that values your contributions and invests in your success.

Total Rewards Package :

BioLab Holdings is an Equal Opportunity employer and does not discriminate based on race, ancestry, color, religion, sex, age, marital status, sexual orientation, national origin, medical condition, disability, veteran status, gender identity, or any other basis protected by law.