The Quality Engineering Technician will support production teams throughout the lifecycle of product.
- Supports Material Review Board (MRB) with nonconformance reports (NCR), including taking part in containment activities, participating in investigations and implementing corrective and preventative actions (50%).
- Works with Quality Control to maintain test equipment, update forms, procedures and other documentation, provide training to personnel and support other activities as needed (20%).
- Maintain and update risk management files (e.g. DFMECA, PFMECA, etc.) as required (10%).
- Monitor and provide feedback on production activity to ensure compliance to procedures, safety and cleanliness requirements are being maintained (10%).
- Support the Quality Engineering department with various activities as needed, including tasks assigned through CRB/MQRB, change orders, equipment qualification, process validation, design validation and verification, DCQPs, etc. (10%).
Required Knowledge, Skills and Abilities:
- Strong interpersonal and communication skills.
- Excellent quantitative and analytical skills.
- Ability to prioritize tasks in a fast-paced environment.
- High level of attention to detail and accuracy.
- Intermediate skills using Microsoft Office products such as Outlook, Word, Excel and Power Point
- Associate's Degree in Engineering or Science, or equivalent work experience, Bachelor's preferred.
- A minimum of six months to one year related manufacturing experience in a QMS environment.
- Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
- Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
- Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
- Attend all required Quality & Compliance training at the specified interval.
- Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.
Environmental/Safety/Physical Work Conditions:
- Ensures environmental consciousness and safe practices are exhibited in decisions.
- Use of computer and telephone equipment and other related office accessories/devices to complete assignments.
- May work extended hours (including nights and weekends) as required to support business needs.
Must be able to stand for several hours throughout the day and be comfortable working in a Controlled Environment.
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