Quality Manager at Harmar Mobility LLC

Description

Want a fulfilling job while working for a Great Place to Work-certified company? Looking for opportunities to grow in your position and enhance your craft? Do you enjoy working with a team, where your opinions and ideas are strongly valued? Lift your life by joining Harmar Mobility, where our purpose is to lift lives within our team, among our network of dealers, and in our communities across the nation. We manufacture mobility device lifts for vehicles and accessibility products to help those with mobility difficulties enjoy their independence and continue to make meaningful memories, whether they’re at home or on the road.

The incumbent site Quality Manager (QM) oversees site specific quality control activities within the manufacturing facility and ensures the highest quality standards. The QM analyzes complaint data daily, reviews negative trends, participates in A3s and problem-solving methodologies, maintains close contact with suppliers, enforces quality inspections and ensures the highest standard of quality in our products.? The Site Quality Manager is the single point for all quality issues to include non-conformances, out-of-box failures, corrective actions, incoming inspection, warranty, manufacturing quality issues, and vendor quality performance.  

The site Quality Manager may be designated as the ETL contact for quarterly audits. All Quality Inspectors, Quality Technicians and Quality Engineers at the manufacturing site report directly to the site Quality Manager. 

 This individual is a key member of the Quality department and will work in close collaboration with the site Production, Engineering, Tech Services and Purchasing teams.  

Management of the site Quality team 

• Manages the Quality Inspectors, Quality Technicians and Quality Engineers to ensure appropriate levels of onboarding, qualification, and cross training. 
• Owns development of the site Quality team including, regular performance reviews, coaching, development of individuals through coaching and training, and use of disciplinary system if needed. 
• Develop Quality team to assist with maintenance of quality tools and systems such as CAPA, NCR, RMA, OOBF, Complaints and Calibration.  

Ownership of Quality product and Quality processes at manufacturing location 

• Establishes and enforces execution of appropriate inspection methods for verification of material upon receipt, for finished product testing, and for handling of materials. 
• Provides training for production employees on quality systems. 
• Drive corrective action to eliminate negative trends and eliminate failures. 
• Interface with the production team and generate Quality Alerts, Deviations or Stop Ship when necessary. 
• Interface with customers and suppliers on quality problems. Contribute to the development of both the supplier and internal quality systems. 
• Set requirements for raw material or intermediate products for suppliers and monitor their compliance. 
• Manage the Return Material Authorization (RMA) program to include evaluation and testing of returned devices.  Data obtained from the RMA evaluation will be analyzed and shared with the organization to improve product support and design.  
• Owner of the Corrective Action and Preventive Action (CAPA) for the site.  Ownership includes training of the manufacturing team to the CAPA process, issuing CAPAs and tracking to completion.  The Quality Manager is expected to be a CAPA coach and resource to ensure effective actions are put in place.   

Interactions with Engineering 

• Audit and approve Engineering Drawings to ensure compliance to GMP, Regulatory and Quality standards (comparing document to actual). 
• Work in conjunction with engineering to create verification and validation plans. 
• Quality representative on the new product development teams and will own the required documentation such as quality plans.  
• Guide engineering team to utilize SPC tools for determining root cause of problems. 
• Provide guidance and training to the Engineering team to ensure all designs and documentation meet document control policies. 
• Assists with the identification of deviations from quality standards and ensures all deviations are documented and recorded. 

Site leadership 

• Ensure all processes and systems are compliant with regulations regarding 21 CFR 820 for Class II Medical Devices. 
• Leads by example for plant quality and safety practices. 
• Participate in safety and plant protection activities. 
• Ensure adherence to health and safety guidelines as well as FDA and legal obligations 
• Submit detailed reports to appropriate executives, as necessary

Requirements

• Minimum five years of Quality leadership experience in a manufacturing environment required.?  
• Proven Experience as a leader in a Medical Device industry 
• Familiarity with electromechanical products, fabrication processes, welding, coating, and assembly processes. 
•  BS Degree in a Technical Field required
• Mechanical or Electrical Engineering preferred
• ASQ certification, Six Sigma Green Belt preferred
•  Strong verbal and communication skills 
• Strong Excel Pivot chart and data mining skills, 
• Power BI experience preferred 
• Coaching and training others experience
• Time management 
• Priority setting 
• Detail oriented