Manufacturing Process Validation & Compliance Engineer

Ready to elevate regulated manufacturing quality?

Do you excel at translating standards into reliable processes? Are test method validations, CAPA, and Device History Records second nature to you? If guiding 1–3 Technicians/Inspectors while partnering with Design, Manufacturing, and Suppliers sounds exciting, this role is for you.

Your impact

• Live our Core Beliefs and uphold all safety and quality requirements across QMS, EMS, company policies, operating procedures, and applicable regulations.
• Be audit-ready: support regulatory and agency inspections, audits, investigations, and inquiries.
• Safeguard manufacturing quality for assigned products, advise on deviations/waivers, and ensure accurate, complete Device History Records.
• Validate changes: review updates to BOMs, Assembly Procedures, Drawings, Component Specifications, FMEAs, and Control Plans for adequacy and correctness.
• Own test method validations from protocol generation to final reporting.
• Coordinate process validations and capability studies with Design and Manufacturing Engineers; recommend process monitoring devices as appropriate.
• Create and improve inspection techniques and procedures to verify conformance to design specifications.
• Write, approve, and implement Incoming, In-Process, and Final Inspection procedures.
• Ensure regulatory-compliant disposition of nonconforming materials; verify effectiveness of corrective actions.
• Lead and manage investigations into customer complaints.
• Advance CAPA effectiveness by analyzing trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes.
• Contribute to continuous improvement projects and support product transfers.
• Work with suppliers, management, Engineers, and Manufacturing associates to resolve quality problems; support capability studies and statistical quality control (Cpk, DOE, Hypotheses Testing, etc.).
• Mentor and support quality inspectors and technicians; provide work direction for 1–3 Technicians/Inspectors.
• Perform other functions as required; other duties as assigned.

What you bring

• Bachelor’s degree in engineering or related field.
• 2–5 years of Quality Engineering experience, preferably in manufacturing.
• Hands-on experience with Quality Engineering tools and techniques.
• Working knowledge of domestic and international regulations and standards (ISO, QSR, UL, MDD, TGA, etc.).
• Proficiency with Microsoft Office and Minitab.
• Clear written and verbal communication; success working independently and on teams.
• Strong organization, time management, initiative, and work ethic.

Physical requirements

Not applicable

Preferred certifications

• CQE, CSQE, CRE, CQA
• Six Sigma Green Belt or Black Belt (desired)