Quality Manager

We are looking for Quality Manager for an impactful medical device manufacturing company. This Quality Manager will oversee all aspects of quality control, including maintaining certifications, conducting inspections, programming machines, and participating in audits. This role requires expertise and leadership in developing policies, procedures, and efficient business strategies.

Responsibilities:

• Manage and prioritize inspections, First Article Inspections (FAIs), and CMM programming.
• Track customer complaints, non-conformances, and Corrective And Preventive Actions (CAPAs).
• Oversee process validations, capability studies, and statistical analysis as required.
• Maintain quality system procedures and ISO 13485 registration.
• Manage calibration systems and gage calibration.
• Oversee Engineering Change Orders (ECOs) and inventory.
• Authorize Material Review Board (MRB) to dispose of items.
• Perform part inspections and coordinate audits (internal and external).
• Manage and supervise a team of six team members.

Supervision:

• Plan, coordinate, and prioritize department workload.
• Assign projects, evaluate work methods, and resolve issues.
• Manage workload, implement improvements, and handle personnel issues, including training, discipline, and performance evaluation.

Qualifications:

• Technical certificate or associate’s degree in programming/process engineering or related field.
• 5 years of quality control experience, including 3 years of supervisory experience.
• Must obtain Lean, Black Belt, and GD&T training.

Knowledge & Skills:

• Advanced knowledge of engineering and geometric dimensions.
• Proficient in measuring tools, ISO 13485, FDA 21CFR820, and ERP systems.
• Skilled in Microsoft Office, SolidWorks, CMM and metrology software.
• Strong math and problem-solving skills.
• Effective communication, leadership, delegation, and organizational skills.