Qa Engineer Jobs

About The Position

Requirements

• A degree in Chemical Engineering or a similar discipline from an accredited college or university, with substantial quality engineering experience in regulated manufacturing environments.
• Advanced application of quality engineering principles, including risk management, root cause analysis, statistical analysis, process capability, sampling plans, measurement system analysis, and data-driven decision-making.
• Experience using quality and statistical tools such as JMP and Excel.
• Demonstrated experience developing and evaluating risk-based validation strategies, including IQ/OQ/PQ/PV, Test Method Validation, measurement system analysis/Gage R&R, and software verification and validation.
• Experience applying risk-based quality engineering to design transfer, commercialization, manufacturing issues, and process changes.
• Advanced written, oral, and presentation skills, including the ability to explain complex technical information, communicate risk and recommendations, influence without direct authority, and present to technical teams, cross-functional stakeholders, and senior leadership.
• Ability to work independently with minimal direction, navigate ambiguity, establish technical direction, and lead multiple high-priority quality initiatives across functions or sites.
• Typically requires a bachelor's degree in a technical discipline and 8–12 years of related experience, or a master's degree and 5–7 years of equivalent industry experience, or a PhD and 2–4 years of experience.

Responsibilities

• Lead complex, high-risk quality investigations, including root cause analysis, CAPAs, NCMRs/MRB, Health Hazard Evaluations, and other product and process risk assessments; drive appropriate disposition and sustainable corrective actions.
• Provide technical leadership and guidance in risk management, Six Sigma, process capability, statistical analysis, sampling strategies, and risk-based problem solving.
• Identify systemic weaknesses and lead sustainable improvements to procedures, process controls, validation frameworks, FMEAs, and other quality processes across functions or sites.
• Define and provide technical leadership for risk-based validation and qualification strategies, including equipment and process qualification, Test Method Validation, measurement system analysis, and software verification and validation.
• Serve as a quality engineering technical lead across complex cross-functional initiatives and communicate technical and compliance issues through documentation, oral communication, and presentations.
• Drive decisions and alignment across functions and sites, including with technical teams and senior leadership.
• Provide risk-based quality leadership for design transfer, commercialization, and significant product or process changes; influence technical decisions and establish controls as products and processes scale to high-volume manufacturing.
• Represent Quality during internal audits and external regulatory inspections, provide subject matter expertise, lead responses to complex technical issues, and help shape organizational quality and compliance strategy.

Benefits

• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursement.
• Opportunity to work with life-changing CGM technology.