Senior Quality Engineer

Precision Matters. Lead Quality That Moves Industries Forward.

Step into a senior-level quality engineering role with a global logistics and manufacturing support organization known for operational excellence, regulatory discipline, and continuous improvement. This opportunity is ideal for an experienced Quality Engineer who thrives in regulated environments, drives process optimization, and partners cross-functionally to ensure products, suppliers, and systems meet the highest quality standards.

Hours & Pay

• Pay Rate: $60-$65 per hour
• Schedule: Monday-Friday, 8:00 AM-4:00 PM (flexible)
• Employment Type: Full-time
• Work Environment: Primarily office-based with occasional exposure to production areas

About the Role

The Senior Quality Engineer is responsible for maintaining and advancing quality systems related to operations, supplier quality, validation, and regulatory compliance. This role serves as a key driver of continuous improvement, risk management, and audit readiness while supporting manufacturing, suppliers, and leadership through data-driven quality initiatives.

Daily Tasks & Responsibilities

• Manage nonconformances by leading root cause analysis and implementing corrective and preventive actions
• Drive continuous improvement through process optimization, automation of measurement techniques, and streamlined SPC requirements
• Support internal and supplier validation and qualification activities, including equipment qualification, process validation, PFMEAs, and risk assessments
• Facilitate technology transfers by developing quality plans, sampling plans, process controls, and test methods
• Perform statistical analysis such as process capability studies, GR&R, DOE, and risk analysis to reduce quality costs
• Lead and participate in Design and Process FMEA activities and update risk management documentation
• Provide manufacturing support by troubleshooting defects, developing inspection methods, and overseeing metrology equipment calibration and maintenance
• Collaborate with quality inspectors to select appropriate measurement and inspection tools
• Manage document control activities, including ECOs, work instructions, and quality system documentation
• Ensure ongoing compliance with ISO standards, FDA regulations, and internal quality procedures
• Lead cross-functional quality projects, manage key quality metrics, and support CAPA initiatives
• Partner with internal teams and external suppliers to achieve departmental and organizational quality objectives

Requirements & Qualifications

• Bachelor's degree in engineering, materials science, chemistry, manufacturing, or a related field
• 5+ years of quality engineering or quality assurance experience in a regulated industry such as medical devices, pharmaceuticals, biotechnology, or manufacturing
• 5+ years of experience producing technical quality documentation, including quality plans, KPIs, NCRs, PFMEAs, and formal procedures
• 5+ years of hands-on experience with ISO standards (ISO 9001, ISO 13485) and FDA regulations (21 CFR Part 820, Part 211)
• Strong knowledge of quality tools, including RCA, SPC, fishbone diagrams, Pareto analysis, process mapping, and control plans
• Advanced Microsoft Excel skills required; proficiency in Word, PowerPoint, and Access
• Ability to work independently while contributing effectively to cross-functional teams
• Strong analytical, problem-solving, and communication skills

Preferred Experience

• Master's degree in engineering, materials science, chemistry, or manufacturing
• Experience leading supplier audits and CAPA investigations
• Six Sigma or Lean Manufacturing expertise
• APQP, PFMEA, and control plan experience
• Familiarity with U.S. and international medical device regulations

Physical Requirements

• Ability to work at a computer for extended periods
• Ability to lift up to 10-15 pounds
• Ability to observe visual and audible safety signals

Benefits & Perks

This role offers weekly pay and access to a comprehensive benefits package designed to support your health, financial well-being, and long-term career growth. Benefits include medical, dental, and vision insurance, life insurance, a 401(k) retirement plan, short-term disability coverage, employee discounts, and additional resources that support work-life balance and professional development.

If you're ready to lead quality initiatives, influence continuous improvement, and make a meaningful impact in a regulated manufacturing environment, click Apply Now to take the next step in your career.

The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depending on the position, benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs.

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