Quality Manager - Food, Medical Device or Pharma Required

Quality Manager

Successful, profitable manufacturer is seeking a Quality Manager to oversee the quality systems and plant quality at a growing site. The Quality Manager will report to the Corporate Director of Quality and work closely with the Plant Manager on quality initiatives and will be responsible for the following tasks:

1. Monitor and improve the quality management system
2. Oversee and ensure regulatory and legal compliance, including leading and guiding all direct reports to ensure compliance
3. Manage and lead root cause analysis and ensure countermeasures are completed
4. Responsible for validation of new and existing products
5. Communicate plant quality KPIs, goals and initiatives to plant management and corporate representatives
6. Prepare for and execute internal and external quality audits
7. Drive and achieve quality continuous improvement initiatives, including cost savings goals for the plant
8. Interact with plant and corporate teams on quality projects
9. Develop and maintain key quality performance indicators
10. Lead and participate in cross-functional teams related to plant quality
11. Partner with R&D for on-site trial activities
12. Execute and improve quality training, including quality orientation training
13. Complete non-routine quality projects and higher level crisis management
14. Assist with vendor qualification
15. Other tasks as assigned by management

Candidates must be able to communicate directly and effectively at all levels, be self-motivated, take initiative on projects, be organized, have excellent attention to detail, and enjoy leading and developing their team. This position will spend up to 30% of the time on the manufacturing floor. Medical benefits are available day one of employment. Other benefits include paid holidays, personal days, vacation, 401K, profit sharing, stock purchase plan and bonus potential.

Requirements for the Quality Manager:

• Minimum of a Bachelor's degree
• At least five years in a similar manufacturing quality leadership role
• Experience supervising others, ideally direct and indirect reports
• Experience overseeing quality in food, medical device or pharmaceutical manufacturing
• QMS (Quality Management System) environments (e.g., ISO 13485) following GMP requirements.
• Hands on experience with pre-requisite programs such as Change control, Pest control, Risk/FMEAs, Calibration, Validation, Annual Product Reviews, Quality Management Reviews, etc.
• Strong background with root cause analysis and CAPA (corrective and preventative action)
• Experience in leading external audits. (auditee of FDA, ISO, or similar Quality System certification audit)
• Microsoft Word, Excel, PowerPoint and Outlook Skills preferred but NOT required