Key Responsibilities:

• Maintain quality systems and follow FDA, ISO, and environmental standards.
• Help operators own the quality process.
• Support the MRB (Material Review Board) and RMA (Return Merchandise Authorization) processes.
• Work with teams to address quality, cost, and scheduling issues.
• Prepare documents such as FMEAs (Failure Modes and Effects Analysis), control plans, quality plans, and PPAPs.
• Lead process validations and reduce the need for inspections.
• Create quality reports and track costs of quality.
• Investigate customer complaints and take corrective actions (CAPA).
• Work on special projects assigned by management.
• Follow Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Apply problem-solving techniques and statistical tools like Six Sigma.
• Work with both internal and external customers.
• Participate in audits and inspections.
• Write and update work instructions and procedures.

Skills & Qualifications:

• Experience in manufacturing operations (forging or machining).
• Knowledge of quality systems and regulatory requirements (FDA, GMP, ISO).
• Ability to read blueprints and use GD&T (Geometric Dimensioning and Tolerancing).
• Proficiency in using measuring devices and software (Minitab, Microsoft Office).
• Strong problem-solving skills and knowledge of 8D techniques.
• Basic math skills (algebra, trigonometry).

Education & Experience:

• Bachelor’s degree in Engineering or a related field, or 6+ years of experience in the Medical Device Industry.
• ASQ CQE or CMQ/OE certification is preferred.
• At least 2 years of experience in a quality role within medical device manufacturing is preferred.
• Familiarity with ISO 13485 and FDA 820 standards is a plus.