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.

Functional Overview:

Single point of contact for all Quality issues. Responsible to interact with multiple functions to produce a culture of collaboration that positively impacts quality at Harmar through various quality disciplines that include (but are not limited to): Statistical analysis, green/lean/black belt quality projects and thorough/accurate reporting related to testing. 

This individual is a key member of the quality department and will work in close collaboration with the Director of Quality, Quality Manager, Quality Compliance and Manufacturing teams (Production, Purchasing, Engineering).

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.

Someone with 21 CFR 820 Medical Devices, ISO 13485 experience would be 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.

• Coordinate Gemba meetings, Assist in CAPA root cause analysis.
• Participate in internal audits and provide strong support to other areas.
• Support Quality Control in containment, investigation, and resolution of non-conformances.
• Maintain nonconforming database, support equipment calibration and calibration nonconformity. investigations.
• Collect data from returns and NCRs for trend analysis.
• Lead lean thinking, team involvement, and problem-solving to improve quality output.
• Evaluate and analyze current quality metrics and feedback to target and reduce quality defects.
• Collecting production data, analyzing outputs, and determining corrective courses of action to promote quality and efficiency.
• Work with management to drive continuous improvement.
• Ensure compliance of manufacturing processes and areas to all applicable quality system regulations.
• Work with manufacturing engineering to ensure necessary process controls and validations are in place and best practices are followed (GMP)
• Supports the test review and verification of protocols and reports for validations.
• Works with Suppliers, Management, Engineers and Manufacturing associates in the resolution of quality problems.
• Conduct product evaluation and failure analysis.
• Participate in safety and internal audits and activities.
• Helps lead root cause analysis for CAPA projects.
• Contribute to the design, development and implementation of product Quality Assurance plans providing feedback for corrective and preventive actions to Engineering, Manufacturing, Service and Suppliers.

Work Environment:

• Duties will take place in the office and warehouse environment.
• Some lifting (<25 lbs.)
• Ability to stand for long periods of time (10 hours).

Requirements:

• Four years of experience in Quality Engineering, Quality Assurance or similar role.
• Proven Experience as a leader in Quality.
• Preferred - Familiarity with electromechanical products, fabrication processes, welding, coating and assembly processes.

Requirements

Skills:

• Experience with FDA compliance and/or ISO13485
• Strong verbal and communication skills.
• Ability to effectively organize data and 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.
• Excellent project management skills.
• Time management
• Must be detail oriented.
• Intermediate (or above) computer skills.

Education/Requirements

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

Harmar's Core Values: 

• Team Players –We lean on each other, are dependable and trustworthy.
• Get stuff Done – We finish the job and possess a strong work ethic
• Can-Do Attitude – A spirit of positivity and flexibility. We go the extra mile
• Genuinely Cares –We are accountable and work to be customer champions.
• Does the Right Thing – Every Time, All the time. No exception, No compromise.
• Embraces Inclusion – We love diversity. Come as you are. We like it that way.

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.