Job Description

Description

If you can drive quality improvements through creating new or enhancing processes, while positively influencing production employees; then you should be successful at Oakworks.  We are looking for a quality engineer with quality assurance experience in a medical device environment.

The Quality Engineer takes a data driven approach to deliver quality initiatives and acts as a change agent in the organization, while managing (2) Quality Specialists. The Quality Engineer is responsible for the administration, oversight of quality control and release of finished product, supplier quality, auditing, non-conforming material. Applying risk management principles (ISO 14971), and an advocate of continuous improvement. Additionally experience desired in investigations and root cause analysis, design assurance, design transfer and validation.

Hours and Status:

The normal schedule is Monday through Friday with some flexibility on start and end times. This is a full time, benefits eligible position

Qualifications

Requirements:

Must have a BS degree in Engineering or related Bachelor’s degree. 10 years’ experience in a quality engineering role with medical device experience (Class 1 and 2) strongly preferred along with knowledge of FDA 21CFR 820, ISO 13485, ISO 14971 and IEC 60601. American Society for Quality (ASQ) QE, Internal auditor ISO 9001 / ISO 13485 and Six sigma certification preferred.

The ability reading blueprints with tolerances with advanced computer skills, trending analysis, project and Quality System software are required.  Physical requirements include the ability to sit/stand/walk for extended periods of time on a daily basis.

WHO WE ARE:

Oakworks is a family owned and run company for over 40 years that produces world class medical, spa, and massage equipment in our modern 91,000 sq ft building. You will be helping to build a wide array of products with a great team of people. We offer a 401k plan, generous company bonus plan, paid time off, 9 paid holidays and opportunities for advancement. Oakworks focuses on the quality of our products and also cares about our employees. Oakworks is proudly promoting health awareness through different activities within the company. We strive on being an employee centered workplace and hold multiple wellness and fun events to show our appreciation.

Equal Opportunity Employer and M/F/Vets/Disability