Job Details

Job Responsibilities

• Manage operations to meet mfg. goals
• Ensure quality standards – ISO 13485
• Ensure compliance with industry regulations
• Manage & mentor team leaders/members
• Promote Lean Mfg. initiatives & continuous improvement
• Partner cross-functionally to support organizational goals
• Maintain a safe & compliant work environment

Job Requirements

• Bachelor's degree in technical field or similar highly preferred
• 7+ years of mfg. & leadership experience – lean mfg. environment experience required
• Strong knowledge of Lean Manufacturing, cGMP, & Med Device/Dental regulations
• Strong written and verbal communication skills
• Familiarity with 21 CFR Part 820, CMDR, MDR, and other global medical/dental regulations preferred
• Experience creating and implementing SOPs preferred