Quality Investigator

Info Way Solutions; Sturtevant (WI); On-site; USD 60,000 - 80,000; Full time

Job summary

Merz Global is seeking a Product Surveillance Associate to assess clinical and safety aspects of post-marketing events, ensuring compliance with global regulations. The role involves interacting with customers, health care professionals, and global teams across levels.

You will process inquiries, review complaints, and conduct investigations in alignment with the Quality System, providing technical guidance and timely closures from the Sturtevant, WI site.

Qualifications

• BS in a Physical Science or Engineering or Equivalent Experience - Required.
• Experience in Quality Assurance and/or other regulated industry or similar experience - Required.
• Strong technical writing and general problem-solving skills - Required.
• Requires Vision Assessment (20/20 near visual acuity & acceptable color vision)

Responsibilities

• Process field inquiries by phone, email or verbal, per SOPs.
• Review complaint records for regulatory compliance and internal procedures.
• Provide technical support and remote troubleshooting guidance as needed.
• Conduct follow-up activities to close records in a timely manner.
• Complete investigations including product returns, manufacturing record reviews, and approvals.
• Execute processing of complaints in accordance with the Company Quality System.

Skills

Quality Assurance

Technical Writing

Problem Solving

Education

Physical Science or Engineering degree

Job description

The Product Surveillance Associate position provides clinical and safety assessments of post-marketing events. This position is an integral role in marketing compliance with global regulations.

Work with minimal supervision and requires a high degree of interaction with customers, health care professionals and Global Merz at all levels within the organization.

Key Responsibilities

Processing the field inquiries received by phone, electronic or verbal correspondence in accordance to applicable SOP(s). Will also be responsible for reviewing complaint records to ensure the records are completed in accordance with global regulations and internal procedures.

Provide technical support and remote troubleshooting guidance as needed.

Conduct follow-up activities to be able to close records in a timely manner.

Complete investigations which may include execution of product returns and subsequent evaluations, reviews of manufacturing records, and assuring proper approvals are obtained as part of closures.

Execute the activities of processing complaints in accordance with the Company Quality System.

Qualifications

BS in a Physical Science or Engineering or Equivalent Experience - Required.

Experience in Quality Assurance and/or other regulated industry or similar experience - Required.

Strong technical writing and general problem-solving skills - Required.

Requires Vision Assessment (20/20 near visual acuity & acceptable color vision)”

Work Location: 13900 Grandview Parkway, Sturtevant, WI