Quality Engineer Medical Device

Title: Quality Inspector
Pay Rate: $25-28/HR  on W2
Location: 13900 Grandview Parkway, Sturtevant, WI

The Product Surveillance Specialist V performs day-to-day tasks and provides technical data assessment of post-market events and can support the Quality Department with Quality System activities including Change Control and Client/CAPA. This position plays an integral role in maintaining compliance with global regulations. The Product Surveillance Specialist V works with minimal supervision and requires a high degree of interaction with customers, health care professionals, global government agencies, and Global employees at all levels within the organization.

Work Environment:
Onsite Required
Overtime limited
Must be able to pass vision testing requirements at 20/20 near acuity vision (with or without corrective eyewear).

Key Responsibilities:
• Independently field inquiries received by phone, electronic or verbal correspondence and determine if it qualifies as a complaint; document reported issues according to applicable SOP(s).
• Provide technical support and remote troubleshooting guidance as needed.
• Independently review associated records, and contact users and customers to collect information on the treatment, product performance, functionality, etc.
• Conduct periodic follow-up to close complaints in a timely manner.
• Manage customer relationship and expectations during the course of the complaint investigation.
• Independently complete investigations, which may include execution or coordination of product returns and subsequent evaluations, review of manufacturing records and ensuring proper approvals are obtained as part of closure.
• Develop solutions to a variety of moderate problems.
• Conduct statistical analysis of complaint trends.
• Support training program by training users on the complaint process and tools used to assess and investigate complaints.

Process Improvement Initiatives:
• Supports and may identify operational changes to improve efficiencies in all aspects of complaint handling.
• Support and sometimes lead investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting.
• Update internal operating procedures and specifications through the Document Change process.

Compliance Initiatives:
• Support and participate in internal quality system audits. Support external quality system audits.
• Evaluate complaints and determine if the submission of a Medical Device Report (MDR) or other Vigilance Report is required.
• Support submitting MDRs and Vigilance Reports according to regulatory timelines.

Education (required):
High School Diploma with 4 years of experience OR Associate's Degree with 2 years of experience OR Bachelor's Degree

Work Experience:
Medical or Surgical Office Experience (preferred)
Customer Service Experience (preferred)

Knowledge, Skills, Abilities:
• Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.
• Basic medical and/or scientific terminology.
• Highly organized with attention to detail.
• Strong ability to prioritize and manage multiple records/reports simultaneously.
• Professional phone etiquette with the ability to appropriately handle sensitive information.
• Effective communication skills including written and verbal.
• Ability to work with company staff and communicate effectively throughout the organization.
• Proficient in Microsoft Office Suite.