Quality Operations Specialist I (cur_1_131017@curatelyai.net)

Job Description

Job Description

"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".

Job Title: Quality Operations Specialist I

Location:  Irvine, CA , 92618

Duration: 12 Months

Pay rate: $25/hr. - $35/hr. on w2

Job Description:

Major Accountabilities:

• Review and investigate assigned technical and clinical customer complaints.
• Perform technical investigations and document results per established procedures and timelines.
• Supports quality functions pertaining to manufacturing line support and maintenance, including SAP.
• Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation
• Assist complaint intake group through review and verification of initial complaint coding.
• Monitor post-market and manufacturing product performance through evaluation and trending of customer complaints, service calls, and manufacturing rejections.
• Ensure that appropriate corrective actions are implemented to address the root cause of trending issues.
• Support and coordinate product/process improvements through collaboration with cross-functional teams (Quality, Manufacturing, R&D, Supply Chain, Finance, etc).
• Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies pertaining to medical devices

Years’ Experience: 2-5 years

• Familiarity with regulatory reporting requirements for medical devices (e.g. MDRs, Vigilance reports, etc);
• Familiarity with medical device complaint files and quality records;
• Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard;
• Strong computer skills (including Excel)
• Demonstrated written and verbal communication skills

Education:

• Bachelor’s Degree in Electrical Engineering or Mechanical Engineering HIGHLY PREFERRED. Other Engineering degrees or Natural Science degrees to be considered with RELEVANT experience in MEDICAL DEVICE TROUBLESHOOTING.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.