Quality Engineer

Department:
Quality
Job Type:
Full Time
Location:
Phoenix, AZ (Onsite)
Date Posted
June 8, 2022

NeoLight is current seeking a Quality Engineer with medical device experience to support new product development and product introduction at our Scottsdale AZ facility.

Duties & Responsibilities

1.1 Support design control activities related to new product development and sustaining engineering, including risk management, measurement system development and validation, statistical analysis, and product acceptance criteria development.

1.2 Supports long term manufacturing quality activities including but not limited to: supplier qualification, supplier development, process quality, product release, and nonconformance resolution.

1.3 Oversees the preparation and integrity of data for the purpose of CAPA management, failure investigations, process validations, and manufacturing process improvements.

1.4 Supports the development and improvement of Quality Systems including but not limited to: Document Control, Training, Internal & External Audits, Compliance, CAPA and continuous improvements.

1.5 Analyzes the QMS and associated data to assure adherence to cGMP's and ISO quality standards.

1.6 Reviews and approves product releases.

1.7 May accomplish tasks through coaching and supervision of support and entry level team members.

Qualifications & Skills

2.1 Masters of Science (MS) in technical field or Bachelor of Science (BS) in technical field and minimum 3 years in medical device related industry.

2.2 Familiarity with medical device regulations, industry or international standards and ability to interpret and implement required processes to maintain compliance.

2.3 Ability to independently perform work of a broad nature with general direction and concurrence from senior management.

2.4 Ability to make risk-based decisions.

2.5 Excellent communication skills (verbal, written, and presentation).

2.6 Ability to effectively manage time and resources. Strong listening, assessment, questioning, analytical and problem-solving skills.

2.7 Strong interpersonal skills required in areas of verbal/written communications, customer focus, professionalism, coaching, team building, and leading.

Let's work together!

If you are interested in this opportunity, please submit your resume and contact information here. Feel free to let us know why you are interested in this position.

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