Quality Engineer

Quality Engineer: NORTHSTAR MEDTECH SOLUTIONS

Industry: Contract Manufacturing & Laser Processing

Job Type: FULL-TIME; EXEMPT

Education Level: Bachelor’s degree in engineering

Reports to: Quality Manager, CEO

Supervisor Responsibilities: NONE

About the Job:

INNOVATION! PRECISION! EXPERIENCE!

This position will serve as the company’s on-site quality representative that works directly with the organization’s Quality Manager. They will champion, support and lead an effective on-site quality management system. The quality engineer will work in a “hands on” environment utilizing a small staff so they must be willing to perform all duties relating to quality matters as needed. The quality engineer will work with the entire team to meet our customers’ high standards of quality, specificity, and on-time delivery.

DUTIES AND RESPONSIBILITIES

Quality:

· The quality engineer monitors and advises on how the management system is performing, which may often include the publication of statistics regarding company performance against set measures. A key role of the quality engineer is that of ensuring that customer requirements and expectations have been accurately identified and that the organization meets or exceeds customer expectations.

· Manage a clearly defined quality management system that all staff can apply.

· Write and maintain process quality control (protocols) and support documentation (reports, work instructions, quality inspection forms) to support all audits.

· Lead investigations for quality issues, implement Root Cause Analysis and drive corrective and preventive actions and report with Quality Manager.

· Encouraging all staff to incorporate a quality-related mindset into their work methods and culture

· Acting as key contact with customers' auditors and being responsible for ensuring the execution of corrective actions and ongoing compliance with customers' specifications.

· Create and update work instructions as required.

· Coordinate with technical staff for carrying out inspections, testing and project activities.

· Manage nonconforming material process

· Manage corrective action reporting (CAR) process

· Schedule and lead Quality Status Update meetings

· Serve as the lead for all external customer audits

· Supervise the internal auditing of management systems

· Assess suppliers' product specifications and quality plans

· Conduct routine supplier audits

General:

· Support Environmental, Health, and Safety (EHS) efforts related to plant equipment, processes, and employees, ensuring compliance with company policies and MNOSHA and OSHA requirements.

· Provide general support to all departments as required, including running production.

· All other duties as assigned.

QUALIFICATION REQUIREMENTS

· Bachelor’s degree in manufacturing and/or engineering field, 2+ years of experience required; may have direct related quality experience without manufacturing or engineering degree, 4+ years preferred

· Quality experience to develop and maintain in-house compliance with ISO 9001 & ISO 13485 standards and all other regulatory organizations.

· Prepare and execute documentation control for internal and external quality audit periods.

· Able to implement and manage a project from start to finish.

· Able to manage multiple tasks or projects simultaneously.

· Excellent organizational, time management skills, and strong decision-making and problem-solving skills.

· Must be able to read mechanical and general fabrication drawings.

· Understand and use precision instruments

· Must have strong attention to detail.

· Must have excellent organizational skills.

· Excellent verbal and written communication skills to interact with diverse employees and customer groups.

· Knowledge of laser manufacturing for welding, marking, cutting.

NICE TO HAVE

· Working knowledge of 3D CAD Software, including SolidWorks

· Working knowledge of ERP/MRP systems

· Lean Manufacturing, Continuous Improvement, Engineering, and Supply Chain Management.

COMPENSATION

This salaried job will depend on related and/or direct experience. We offer a comprehensive benefits package. This includes major medical, disability, life insurance, PTO, Sick Time, Leave Time, and a retirement plan with company match.

WORK AUTHORIZATION

Applicants must be currently authorized to work in the United States without the need for employer sponsorship. This position is not eligible for employer-sponsored work authorization, including H-1B sponsorship or employment-based permanent residency, now or in the future.

License/Certification:

• Driver's License (Required)

Ability to Commute / Ability to Relocate:

• Plymouth, MN 55446 (Required)

Work Location:

• In person

Job Type: Full-time

Pay: $85,000.00 - $100,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance