Quality Manager

SUMMARY: The Quality Manager is responsible for implementation of new customer processes, including design and development of production fixtures and workflow documentation. Also responsible for process changes and enhancements that support company and customer objectives. Responsible for defining, documenting and ensuring correct and optimally efficient implementation of processes used by the company.

RESPONSIBILITIES:

• Perform Inspection Supervisor area duties
• Implement new customer processes including process transfer from development to production
• Assess customer specifications, drawings, and change orders for proper implementation
• Evaluate, define, and implement internal process changes and enhancements
• Drive new projects to completion through robust project management including management of internal and external resources
• Create, review, and refine process validation documents including IQ’s, OQ’s, and PQ’s
• Create, review and edit process flow maps and p-FMEA documents
• Create, review, and improve training instructions
• Define and develop testing methodologies for new and existing processes including QC methods
• Drive an increase in manufacturing efficiency through analysis of workflow, processes, tooling and equipment
• Troubleshoot production and workflow issues
• Collect data and provide data analysis, interpretation, and trending derived from the Inspection Access database or other data sources, including tracking of management-defined KPI’s
• Design fixtures for customer trial and processing runs
• Assist with production-related activities, as requested, including setup, run configuration, and certification
• Evaluate proposed trials and production jobs for the company’s ability to implement them, and provide quantitative assessments of resource requirements, including labor, materials, and equipment, for input into financial cost estimate models
• Meet with customer and regulatory personnel for quality and design
• Attend periodic MEL meetings; determine root cause of quality issues and implement solutions
• Train area technicians and perform retraining as needed
• Recommend alterations to development and design to improve quality of processes and/or procedures
• Assure that the company’s efforts are in full compliance with the company's quality policies, ISO and other relevant regulations.
• In Manager role, responsible for:
  • Managing the workflow of department employees and delegating tasks.
  • Ensures that assigned employees are equipped with the tools they need to be successful in their positions.
  • Assessing the work performance of assigned employees and identifying areas that need improvement. This includes the completion of performance reviews.
  • Ensure that business goals and performance standards are met.
  • Maintains staff by recruiting, selecting, orienting, and training employees.

SUPERVISORY RESPONSIBILITY

• Supervises Set-up/Inspection Technician group.

ESSENTIAL QUALIFICATIONS:

• Bachelor's Degree in Manufacturing, Industrial, Electrical, or Mechanical Engineering
• 3+ years in a leadership position.
• 5+ years of hand-on professional experience in a Medical Device manufacturing environment
• Experience in a regulated environment such as medical devices
• A collaborative mindset, a flexible and friendly approach to working in teams
• Familiarity of LEAN principles preferred
• Highly Desired Skills:
  • Personnel management skills
  • Strong spreadsheet/Excel skills, strong MS Word skills
  • Working knowledge of ISO standards

KEY SUCCESS FACTOR

• Pay Attention to the Details: Missing just one detail can have an enormous impact on a job. Be a fanatic about accuracy and precision. The goal is to get things right not simply to get it done. Double check your work. Get the details right the first time.
• Make Quality Personal: Demonstrate a passion for excellence and take pride in the quality of everything you touch and everything you do. Have a healthy dislike for mediocrity. Good is not good enough. Always ask yourself, “Is this my best work?
• Honor Commitments: Be true to your word. Be punctual for all meetings and phone calls. If a commitment cannot be fulfilled, alert others early and agree to new deliverables.
• Get Clear On Expectations: Create clarity and avoid misunderstandings by discussing expectations upfront. Set expectations for others and ask when you’re not clear on what they expect of you. End all meetings with clarity about action items, responsibilities, and due dates.
• Deliver Legendary Service: It’s all about the experience. With every experience, do the little things, as well as the big things, that surprise people. Make every interaction stand out for its helpfulness. Create the “WOW” factor that turns customers into raving fans. This includes both internal and external customers.
• Be Relentless About Improvement: Regularly evaluate the way you/we work to find ways to improve. Don’t be satisfied with the status quo. “Because we’ve always done it that way” is not a reason. Guard against complacency. Find ways to get things done better, faster and more efficiently.
• Practice Blameless Problem-Solving: Demonstrate a relentless solution focus, rather than pointing fingers or dwelling on problems. Identify lessons learned and use those lessons to improve ourselves and our processes so we don’t make the same mistake twice. Get smarter with every mistake. Learn from every experience.

PERSONAL PROTECTION EQUIPMENT:

• Following items are available as needed:
  • Safety glasses are required in designated areas.
  • Company supplied uniforms and/or gowning must be worn in designated areas.

PHYSICAL DEMANDS: While performing the duties of this job, the employee is asked to use their arms, hands and fingers for an extensive period of time. The employee will be frequently sitting, standing, walking and carrying items of less than 40lbs.

LANGUAGE SKILLS: Employee must be able to read and interpret documents written in English. Employees must be able to have good communication with fellow employees, supervisors, and management.