Engineer Quality

This position is a technical individual contributor responsible for applying engineering principles, data analysis, and risk-based methodologies to design, implement, and improve quality processes and controls. This role supports compliance with regulatory, customer, and internal requirements by leading technical quality activities such as process qualification, equipment and systems validation, environmental monitoring, and corrective action effectiveness. This role partners cross-functionally to ensure quality is built into systems, processes, and operational execution, supporting complex or highly regulated facilities or network-wide services design and implementation.

Responsibilities

• Apply engineering and quality principles to design, implement, and maintain effective quality controls across operations.
• Lead or support process qualification, validation, and requalification activities in accordance with applicable regulatory and quality requirements.
• Lead or support equipment and systems qualification activities, including warehouse temperature mapping studies, environmental monitoring validation, and ongoing requalification.
• Analyze quality data, trends, and process performance to identify risks, root causes, and improvement opportunities.
• Lead or support root cause analysis, corrective and preventive actions (CAPA), and effectiveness verification.
• Develop and maintain technical quality documentation, including validation protocols, reports, and risk assessments.
• Support new customer onboarding, process changes, equipment installations, and system upgrades from a quality and validation perspective.
• Partner with Operations, Engineering, IT, and Quality teams to ensure compliant and scalable technical solutions.
• Support internal, customer, and regulatory audits and inspections within assigned technical scope.
• Other duties as assigned.

Requirements

Qualifications & Experience

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical field.
• 4 years of experience in quality engineering, validation, or regulated operations.
• Demonstrated experience applying engineering principles in quality or compliance-focused environments.
• Formal training or certification in Lean, Six Sigma, or quality risk management methodologies; Internal candidates to demonstrate QDM proficiency with QDM Expert certification.
• Experience in performing validation, qualification, or technical risk assessments.

Preferred Qualifications & Experience

• Experience in regulated environments such as medical devices, pharmaceuticals, healthcare logistics, or food grade operations.
• Working knowledge of ISO-based quality systems (e.g., ISO 13485, ISO 9001), GMP, GDP, HACCP, FSMA, or similar frameworks.
• Hands-on experience with equipment qualification, systems validation, and environmental monitoring programs.
• Experience conducting warehouse temperature mapping studies and managing ongoing monitoring programs.
• Familiarity with statistical analysis, SPC, or data visualization tools.
• Formal training or certification in validation, Lean, Six Sigma, or quality engineering methodologies.

Skills & Abilities

• Strong technical, analytical, and problem-solving skills.
• Ability to interpret and apply regulatory and engineering requirements.
• Proficiency in data analysis and technical documentation.
• Excellent written and verbal communication skills.
• Ability to work independently with minimal supervision.
• Strong organizational and project management skills.
• Ability to influence cross-functional stakeholders without direct authority.
• High level of integrity, precision, and attention to detail.

Physical & Cognitive Requirements (With or Without Accommodation)

• Ability to follow policies and procedures.
• Ability to read, write, and interpret information.
• Ability to add, subtract, multiply, and divide.
• Ability to use hands to finger, handle, or feel.
• Ability to sit, walk, or stand for the duration of the shift.
• Must possess visual acuity to perform essential job functions.
• Ability to conduct physical tasks with a full range of motion throughout the warehouse environment.
• Ability to lift/carry items up to 50 pounds.

Benefits

• Competitive pay, paid bi-weekly for both full-time and part-time opportunities.
• 401K plan with company match after 1 year.
• Tuition reimbursement program.
• Holiday pay and accrued paid time off programs offering both Vacation and PTO.
• Medical, dental, vision, and voluntary benefits available on day one.
• Basic life insurance and basic AD&D coverage.
• Supplemental Life and Supplemental AD&D.
• Short-Term and Long-Term Disability coverage for full-time employees after 180 days of service.
• Paid parental leave for both moms and dads.
• Paid bereavement and jury duty.