IMPACT and OPPORTUNITY:

We have an opportunity for an experienced and self-motivated Manufacturing Quality Manager. The ideal candidate thrives in complex situations requiring problem solving and high levels of process improvement thinking – you are experienced at making the complex simple. The role reports to the Plant Manager / dotted line to QA/RA Executive Director and manages a Manufacturing Quality Team.  This role is 100% onsite working in a production environment and needs to be available to work 7:00am-4:30pm.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

• Assesses and improves the quality of product in production and service departments.
• Conduct effective root cause analysis on safety and quality issues, implements corrective and preventative actions.
• Acts as a change agent to consult and improve results by streamlining basic processes.
• Understands production metrics and works with teams to improve KPIs (delivery, cost of quality, safety).
• Establishes and enforces quality standards and specifications with vendors in collaboration with Production, Purchasing, R&D, Service and QA/RA teams.
• Provide manufacturing support for Gentherm QMS processes.
• Responsible for monitoring medical device industry trends for assigned QMS processes.
• Responsible for investigations as required to support the MRB, CAPA, Supply Chain, and Post-Market Surveillance.
• Responsible for Manufacturing support for assigned development / continuous improvement projects.
• Responsible for management of employees involved with manufacturing.
• Carries out management responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
• Supports the Plant Manager and Quality Management Representative, as required.
• Responsible for assigned duties to support Manufacturing and Quality to meet department objectives.

MINIMUM QUALIFICATIONS:

• Bachelor's degree in Mechanical, Electrical, Quality, or Manufacturing Engineering
• Minimum of 8 years of relevant experience
• Minimum of 3 years of management experience with proven record to effectively lead and develop team
• Analytical and quantitative approach to problem solving
• Prior Project Management, problem-solving experience
• Prior Manufacturing process improvement experience
• Excellent verbal and written communications skills
• Lean Manufacturing/Six-Sigma Green or Black belt
• Proficiency of Microsoft Office Products (Outlook, Word, Excel, PowerPoint)

PREFERRED QUALIFICATIONS:

• Experience in a regulated industry, preferably medical device
• Demonstrated success in delivering productivity and cost improvements
• Knowledge and experience using ERP system