What are the responsibilities and job description for the Sustaining Quality Engineer position at BioLab Sciences?

Job Title : Sustaining Quality Engineer

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 manufacture reliable and safe products with the highest quality to help optimize body performance through continuous innovation, education, superior customer service, and teamwork. Since its founding, BioLab Holdings has experienced explosive growth and is actively developing new technologies to innovate, improve the 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 : Senior Director of Quality & Regulatory Compliance

Job Overview :

We are seeking a detail-oriented and hands-on Sustaining Quality Engineer 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 supporting the validation of new and existing equipment, addressing non-conformances, reviewing process instruction and workflows for compliance, and ensuring the highest standards of quality throughout the product lifecycle.

Essential Functions :

Validation Strategy & Protocols :

Develop, review, and execute validation strategies and protocols utilizing technical writing and ensuring they meet regulatory requirements
Support the evaluation of validation strategies and risk assessments for new equipment or changes to existing equipment

Compliance :

Review and evaluate procedures for compliance and utilization of Good Manufacturing Practices (GMP)

Assist in ensuring that testing and verification and processes adhere to GMP standards and operational best practices

Risk Management and Continuous Improvement

Conduct risk analysis for nonconformances, continuous improvement efforts, and validation activities to maintain regulatory compliance and effective product management

Identify potential risks and work with cross-functional teams to implement solutions

Protocol Generation :

Create and support the generation of validation protocols, reports, and other documentation using clear technical writing

Ensure efficient workflows for protocol development and efficient workflows

Data Analysis :

Perform data collection, analysis, and review to identify trends, areas of improvement, and escalation needs

Lead efforts to investigate and resolve quality issues identified through data analysis

Process Control & Compliance :

Review and support test methods, inspection procedures, and other process controls to ensure compliance and identify opportunities for improvement

Provide support on audits and response coordination

Nonconformance & CAPA Support :

Provide support on Nonconformances, Corrective and Preventative Actions (CAPA) investigations, and Complaints

Support in conducting root cause analysis for quality events and investigations

Training and Best Practices :

Provide training and guidance in manufacturing on quality-related best practices, procedures, and compliance standards

Facilitate the continuous improvement of quality practices across the organization

This job description is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the job. Other duties may be assigned.

Qualifications : Education :

Minimum Bachelor's degree, preferably in Engineering or Life Sciences

Experience :

Minimum of 2-4 years of experience in the pharmaceutical or medical device industry

Strong experience with validation planning & execution, risk assessments, and technical writing

Knowledge of GMP, ISO standards, and other regulatory requirements

Skills & Competencies :

Extensive knowledge of quality systems and continuous improvement methodologies

Excellent communication skills with the ability to work collaboratively in a cross-functional environment

Detail-oriented with the ability to handle complex issues and drive solutions effectively

Proficient in technical writing, protocol development, and data and risk analysis

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 :

Competitive Salaries

Health, Dental, and Vision Insurance

Retirement Plans

Tuition Reimbursement

Generous Paid Time Off

Employee Assistance Program

No premium payments

BioLab Sciences 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.

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