Quality Engineer
The GN Group

Job Info

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Reports to Title:

Sr. Quality Manager

Department/Division:

Quality

Primary Work Location:

Bloomington, MN

Job Code/Classification

Exempt

Position Overview

This position is responsible for supporting Quality processes and systems compliant to FDA regulations and ISO requirements related to the sale, manufacture, service and distribution of Hearing Instruments and related accessories.

Essential Functions (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

• Develop and maintain quality system related procedures according to FDA regulations and ISO requirements
• Develop and execute training, including competence assessment, for quality-related processes and procedures
• Create, review and approve Engineering and Manufacturing Change Orders
• Work cross-functionally to conduct root cause investigation, action planning and verification of effectiveness for CAPA
• Work with manufacturing, supply chain, engineering, and others to solve internal and external supplier quality issues; investigate non-conforming product and recommend disposition
• Design, supervise, and perform quality methods such as failure mode effects analysis, statistical process control and gauge studies
• Establish and maintain systems/methods to monitor incoming, in-process and shipped product quality to ensure safety and performance, identify trends and drive improvements
• Communicate with local, global and corporate functions and customers (dispensers), as needed, to resolve system and product quality issues, including customer complaints
• Drive Quality Planning Process including FMEA (Risk Management), Control Plan and Process Audit, etc.
• Establish and maintain inspection procedures based on the material/product specifications and customer requirements
• Support planning and execution of internal, external and cross-site audits
• Establish and review process, equipment and test method validation documentation (IQ, OQ, PQ, PV, TMV)
• Take part in process and equipment validation

Competencies (Knowledge and Skills needed for this position.)

• Practical application of medical device regulations and standards to system/process development
• Strong verbal and written communication skills
• Problem solving skills
• Detail oriented
• Root cause analysis
• Risk assessments
• Excellent organizations skills to manage multiple priorities
• Excellent understanding and execution of Good Documentation Practices
• Self-directed
• Drive continuous improvement throughout the organization

Desired Qualifications

Required Education (if necessary):

Bachelor's Degree in Engineering or equivalent experience.

Experience (if necessary):

4+ years related work experience: (Quality Engineering, Quality Control, Quality Improvement Projects, Root Cause Analysis, CAPA) preferred.

Experience in Medical Device Manufacturing, ISO 13485, highly preferred.

Travel (if necessary):

Minimal travel - as required

Other:

Other Information

Direct reports:

N/A

Indirect reports:

N/A

Working Environment:

Manufacturing facility and office environment

Physical Demands:

Sitting, standing, lifting, bending, reaching, no more than 20 lbs.

Position Type and Expected Hours of Work:

Full-time position +

Monday-Friday

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

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This job has expired.