Quality Engineer (3 month contract)

Kelly Science, Engineering, Technology & Telecom; Grand Rapids (MI); On-site; USD 55,000 - 62,000; Full time

Job summary

Kelly Science seeks a Quality Engineer for a short-term contract in Grand Rapids, MI. The role supports nonconformance and complaint investigations in a GMP-regulated medical device or OTC pharmaceutical environment.

Requirements include a life science/engineering degree and at least three years of GMP experience, with strong attention to detail and solid communication skills for cross-functional collaboration.

Qualifications

• Bachelor’s degree in life science, engineering, physical science, or a related field.
• At least three years of experience in a GMP-regulated medical device or OTC pharmaceutical environment.
• Experience reviewing investigation records and manufacturing documentation for accuracy.
• Strong attention to detail, critical thinking, and clear communication with stakeholders.

Responsibilities

• Support nonconformance and complaint investigations in a GMP-regulated medical device or OTC pharmaceutical environment, ensuring investigations are thorough and documented.
• Review investigation case details, supporting documentation, and batch records as needed.
• Monitor open investigations and follow up with stakeholders to keep cases progressing and on time.
• Collaborate with operators and process stakeholders to confirm reported nonconformances and gather facts.
• Assist with investigation documentation, including issue descriptions, evidence, root-cause, containment actions, and dispositions.
• Review investigation records for completeness and GMP compliance; identify gaps and follow-up needs.
• Track investigation status and closure performance; escalate delays or gaps.
• Support complaint-trending and nonconformance review by identifying recurring issues and patterns.
• Partner with Quality, Operations, and other teams to ensure timely resolution and follow-through on corrective actions.

Skills

Attention to detail

Analytical thinking

Effective communication

Education

Bachelor's degree in life science, engineering, physical science, or related field

Job description

Kelly Science is seeking a Quality Engineer for a short term contract opportunity with a growing company located in Grand Rapids, MI.

Pay: $40-45/hour

Schedule: Monday-Friday 1st shift

Employment Type: Full Time; 3 month contract

Job Responsibilities:

• Support nonconformance and complaint investigations in a GMP-regulated medical device or OTC pharmaceutical environment, helping ensure investigations are thorough, well documented, and completed on time.
• Review investigation case details, supporting documentation, and available product or process records; retrieve and review batch records and related paperwork as needed.
• Monitor open investigations and follow up with stakeholders to keep cases progressing, including providing investigation-review coverage during team absences.
• Work with operators and other process stakeholders to confirm reported nonconformances, clarify events, and gather relevant facts from the work area.
• Assist with investigation documentation, including clear descriptions of the issue, evidence reviewed, root cause rationale, containment actions, corrective actions, and material disposition, as applicable.
• Review investigation records for completeness, consistency, and compliance with applicable GMP and quality-system requirements; identify missing information or follow-up needed before closure.
• Track investigation status and on-time closure performance, escalating delays or investigation gaps to the appropriate stakeholders.
• Support complaint-trending and nonconformance review by identifying recurring issues and communicating potential patterns for further assessment.
• Partner with Quality, Operations, and other relevant teams to support timely investigation resolution and appropriate follow-through on corrective actions.

Qualifications:

• Bachelor’s degree in life science, engineering, physical science, or a related field.
• At least three years of experience in a GMP-regulated medical device or OTC pharmaceutical environment, with experience supporting or reviewing nonconformance and/or complaint investigations.
• Experienced in reviewing investigation records and manufacturing documentation for completeness and accuracy.
• Strong attention to detail, critical-thinking, and communication skills, including the ability to gather information from operators, track investigation actions and deadlines, and escalating gaps or delays.