Manufacturing Quality Manager

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 has five direct reports (one Quality Engineer, two inspectors and two testers). 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, and QA/RA teams.
• Oversees the compliance and execution or management of the following processes/activities:
  • Acceptance Activities
  • Quality Inspection and Final Test
  • Medical Device Manufacturing and process improvement
  • Process development, verification and validation
  • Design Transfer
  • Manufacturing and Quality Gemba and KPI management
• Provides support to the following processes:
  • Statistical Techniques
  • Deviation Notices
  • Control of Non-Conforming product
  • Calibration of Measurement and Test Equipment
  • Purchasing and Supply Chain
  • New Product Development and Sustaining Engineering
• Provide manufacturing support for Gentherm QMS processes.
• Responsible to monitor medical device industry trends for assigned QMS processes.
• Responsible for analyzing and trending data to facilitate continuous improvement efforts and effectiveness of product lines.
• 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.
• Effectively training people inside of the workgroup and leads projects.
• Supports the Plant Manager and Quality Management Representatives, 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
• Six-Sigma Green or Black belt
• Knowledge and experience using ERP system
• Analytical and quantitative approach to problem solving
• Prior Project Management, problem-solving experience
• Prior Manufacturing process improvement experience
• Excellent verbal and written communications skills
• 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

COMPETENCIES:

• Deliver Results
  • Understand the mission and output of your team; set SMART objectives and deliver
• Drive Change
  • Focus on agility and commitment to continuous improvement; Understand and act on internal and external drivers of change
• Build Capability
  • Foster a culture of learning and development; Support individual growth through continuous feedback to achieve personal and professional goals
• Cultivate Innovation
  • Openly embrace, create, implement and support new and innovative ideas, processes and technology that deliver business results