Quality Engineer - Manufacturing

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.

Harmar Mobility is a Drug-Free Workplace and an Equal Employment Opportunity employer.

This position reports directly to the Quality Assurance Manager. This person will need to be confident in working on cross-functional teams and serve as a key technical resource in product support, document development, Quality compliance, maintenance of the document database, and as a Super User for both company sites.

This position requires someone with 21 CFR 820 Medical Devices. ISO 13485 experience a plus. Must be comfortable working on cross-functional teams and serve as a key technical resource in product support, document development, maintenance of the document database.

• Non-Conforming Material disposition
• Collects data from returns and NCRS for trending analysis
• Coordinates GEMBA meetings
• Works with manufacturing engineering to ensure necessary process controls are in place for design changes.
• Quality Trainer for Inspectors
• Helps lead to Root Causes for CAPA responses
• Liaison between Supplier and Harmar regarding quality issues
• Participates in Internal audits
• Contribute to the design, development, and implementation of product quality assurance plans providing feedback on corrective and preventative actions to engineering, manufacturing, service, and field operations and supplier performance
• Oversees all customer returns (OOBF, Warranty, Complaints, etc.)
• Failure Analysis of Returns
• Quality Team Lead
• Quality Subject Matter Expert for all Quality areas
• Supports Quality managers in their absence
  
  

Requirements

Skills

• Role experience with a medical device manufacturer in compliance with ISO 13485 the FDA preferred.
• Excellent communication skills, both verbal and written.
• Ability to effectively present information.
• Strong analytical and problem-solving skills.
• Self-motivated and proactive with strong customer service orientation.
• Ability to establish and maintain effective and cooperative working relationships with those contacted in the course of work.
• Experience with data organization and presentation.
• Excellent project management skills.
• Intermediate or above skill in the use of Microsoft Office Suite required.
• Project completion driven.
  
  

Education/Requirements

• Degree in quality, industrial, or mechanical engineering.
• 4 years of experience in quality engineering, quality assurance, or a similar role.
  
  

Harmar Has Great Benefits

• Medical, FSA, HSA, Dental, Vision, STD, LTD after 60 days of full-time employment
• Harmar offers $50,000 Life Insurance first day of employment
• 401(k) matching after 6 months of full-time employment
• Paid Vacation time (80 hours) ,Sick/Personal time (30 hours) after 90 days of full-time employment (prorated based on hire date)
• Eight Paid Holidays and one Floating Holiday per year
• Fitness and PPE Reimbursement
  
  

Harmar Mobility is an equal opportunity employer and does not discriminate against otherwise qualified applicants on the basis of race, color, creed, ancestry, religion, orientation, age, sex, marital status, national origin, disability, genetic information, or veteran status.