Quality Assurance Engineer II 8/31/2016
JOB DESCRIPTIONAPPLY JOB TITLE: QUALITY ASSURANCE ENGINEER
LOCATION: PHOENIX, AZ
"looking for somebody with experience in Quality Assurance on Medical devices with focus on writing SOP's, training, CAPA and FDA experience. The position is not an experienced level role, it is more like entry to mid-level for somebody with 3-6 years of experience. Preferable, If they have ISO13485 experience. From the other resumes, Tomas Wetteroth had some of the elements I am looking for, but he has been primarily in Management positions and that is not what we are looking for at this time. "
KEY RESPONSIBILITIES INCLUDE:
1. Responsible for supporting the Site Quality Assurance team in the management of quality systems, processes and procedures to assure product quality and safety.
2. Responsible for supporting the design and manufacturing teams in accordance with documented procedures and practices.
3. Assists the Quality Assurance Site Manager to ensure/follow up/implement corrective actions that are raised by deviations, internal audit or regulatory inspection
4. Facilitates the implementation of Production and Process Control changes at the site.
5. Participates in efforts to ensure audit-readiness and helping in the resolution of documentation issues, as required.
6. Supports Quality Management Systems documentation workflow and ensures compliance with relevant Document Management procedures and work instructions, as required
7. Ensures training programs are current and employees are trained in accordance with latest regulatory requirements at a function or segment of the business.
1. Bachelor's degree (or high school diploma/GED plus 4 years of experience work experience)
2. Three years of experience working in a regulated medical device, and knowledge of quality system regulations and policies
3. Required experience with some or all of the following: Production and process controls, Design controls, design verification and validation activities, CAPA and risk management
4. Experience performing internal audits
1. Effective oral and written communication skills
2. Analytical & problem-solving skills/root-cause analysis
3. Effective interpersonal and networking skills