Job description

About us

MedFab is a growing company working primarily in the medical device industry. Our work environment is positive and forward thinking. The people we hire are customer focused, employ a strong work ethic, are honest and respectful, and are looking for continuous growth and improvement.

Job Details

MedFab is a growing company working primarily in the medical device industry. Our work environment is positive and forward thinking. The people we hire are customer focused, employ a strong work ethic, are honest and respectful, and are looking for continuous growth and improvement. We are seeking a highly experienced and motivated Quality Manager to join our team. As the Quality Manager, you will be responsible for ensuring that our products and services meet the highest quality standards.

This person will be responsible for supervising and proactively leading the operation of the quality department and implementing our Quality Management System to ensure customer satisfaction.

Role/Responsibilities

• Lead implementation of a quality management system that meets the needs and requirements of ISO 13485:2016
• Ensure that processes needed for the quality management system are documented.
• Report to senior management on the effectiveness of the quality management system, the importance of meeting customer as well as applicable regulatory requirements, and any need for improvement.
• Establish the quality policy
• Ensure that quality objectives are established
• Conduct management reviews
• Ensure the availability of resources for the Quality Management System
• Ensure the promotion of awareness of applicable standards, requirements, and quality management system requirements throughout the organization.
• Customer Concern Management. Investigate customer concerns, perform Root Cause Analysis, and develop Corrective and Prevention Actions. Lead the resolution and ensure timely follow-up of quality issues to maintain customer satisfaction.
• Becomes personally skilled in all inspection and testing procedures.
• Mentor and develop staff in a manner which results in qualified, productive and satisfied employees who are able to successfully respond to changing customer needs.
• Create and implement a natural culture of quality that is woven into the manufacturing process.
• Identify errors and inefficiencies in the process, then lead the change to resolve.
• Identify quality continuous improvement initiatives and present business case proposals.
• Collaborate with other departments to create the best flow of quality streams.
• Implement and communicate metrics to drive improvements to goals.
• Actively serve as a proactive leader and natural mentor to staff. Communication and feedback a must.
• Provide leadership to sustain a quality philosophy and lean culture throughout the company.
• Improve product and service quality through ISO 13485 compliance, problem-solving tools, prevention methods, and quality at the source.
• Develop and maintain standardized work instructions for the quality department
• Manage corrective/preventative action data - assist team with actions to resolve nonconformities.
• Compile nonconformance trend analysis reports and drive root cause resolution.
• Collaborate with Purchasing and Engineering to drive incoming quality.
• Single point, proactive customer interface on quality related issues.

ISO 13485 Compliance

• ISO audit point person and project manager
• Owner of Quality Manual, refinements and compliance of process in the shop flow.
• Manage, update and distribute quality system documentation to meet ISO 13485 requirements
• Continuously improve the effectiveness of the quality system
• Lead initiatives for internal, customer and third-party quality system audits
• Report audit activities and results, perform comprehensive follow up of corrective action requests
• Report the status of quality indicators such as the cost of quality, scrap costs, TQM survey results, etc.

Required Skills:

• Strong attention to detail.
• Successful supervisor experience required
• Must be able to create a plan to improve and drive to completion across departments.
• Demonstrated leadership, project management, facilitation and problem-solving skills
• Proficient at figuring out new computer systems
• Must be organized and efficient
• Must be able to multi-task, stay professional and calm in a fast-paced environment
• Must have knowledge of ISO 9001 International Standard Requirements for Quality Management Systems, knowledge of ISO 13485 is preferred.
• Advanced print reading skills include GD&T
• Experience with quality improvement tools and techniques (i.e., Lean, Six Sigma, Statistical Process Control and Failure Mode & Effects Analysis)
• Ability to read, analyze, and interpret technical procedures and scientific literature. Ability to write reports and business correspondence.
• IQ, OQ, PQ experience

Preferred Education / Experience:

• Bachelor’s degree in related field of engineering, science, or regulatory affairs, or equivalent experience.
• 5+ years in manufacturing environment in a leading quality role
• CMM programming experience

Job Type: Full-time

Pay: $80,000.00 - $95,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Paid time off
• Vision insurance

Schedule:

• Day shift

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Lakeville, MN 55044: Reliably commute or planning to relocate before starting work (Required)

Experience:

• ISO 9001 or ISO 13485: 3 years (Required)

Work Location: In person

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